3rd International Forum of Pharmaceutical Inspectorates. Agenda Structure
Hanoi, Vietnam
Hanoi, Vietnam
Plenary Session, November 16
Good regulatory practice: harmonizing and strengthening regulatory systems for medicinal products
Implementing good regulatory practice: pathways for process optimization and increasing regulatory efficiency
International experience in reforming the regulatory system based on good regulatory practice approaches: pathways and prospects
Flexible regulatory environment: ensuring timely response to emerging risks and challenges
Transparency as a foundation for reliance and cooperation: path to regulatory excellence
Transparency, participation and accessibility: a comprehensive strategy for ensuring transparency in regulation
Aligning best global practices with national standards
Implementation of guidelines of international organizations to improve regulatory processes
Multifaceted approach to regulatory effectiveness science, risk assessment, and international cooperation to achieve public health objectives
Stakeholder engagement in regulatory process:
Mechanisms for public consultation on draft laws and regulations
Consultations with businesses, expert communities, and civil society
Launching platforms for dialogue and feedback
Raising awareness of regulatory changes
Digitalization of regulatory processes:
Development of common platforms to submit documents and receive authorization
Artificial Intelligence for regulatory risk analysis and forecasting
Automation of compliance checks and monitoring
Ensuring accessibility and user-friendliness of digital services for business
Regulatory Session, November 16
Current regulatory approaches: experience and future perspectives
Manufacturing Regulatory Aspects of High-Tech Medicinal Products and Blood Products.
Regulatory strategies for CAR-T: global approaches and local differences
Regulatory aspects of plasma collection and plasma testing for blood manufacturing: challenges and solutions
Certification of plasma master files
Expert sessions, November 16-17
Good Regulatory Practice: Modern Approaches
1. Digital Transformation of Import Licensing: From Paper-Based Document Flow to Electronic Platforms and Blockchain Solutions.
2. Harmonisation of National Licensing Systems with International Trade Agreements: Experience and Best Practices.
3. The Role of Import Licensing in Ensuring National Security and Consumer Protection: Contemporary Challenges and Effective Mechanisms.
4. Impact of Regional Trade Blocs on Import Licensing Practices: Unification or Diversification of Approaches.
5. Import Licensing: Barrier or Necessity?
6. Use of Data and Analytics for Optimisation of Import Licensing Processes: Risk Prediction and Efficiency Enhancement.
Technology: advancement and development
Advanced Therapy Medicinal Products: manufacturing approaches and quality control
Environmentally sustainable culture media: innovations when using renewable resources and waste minimization in culture media production, and their impact on green biotechnology
New sources of nutrient components: investigating alternative sources of amino acids, vitamins, and growth factors of non-animal origin to enhance the safety and ethical standards of cell technologies
Specifics of CAR-T manufacturing inspection
Inspection of plasma centers
Cross-contamination control, comparability, and lifecycle management in the production of gene and cell therapy products: key inspection areas and regulatory expectations
Inspectorate oversight of personalized and ultra-small batch production: approaches to inspecting highly variable drug products and personalized medicinal products
Radiopharmaceuticals: challenges in manufacturing and practical use
Specific challenges and aspects of radiopharmaceutical industry: Radioactive materials: GMP requirements for facilities, equipment, and personnel.
Short shelf life of many radiopharmaceuticals and its impact on logistics and control
Challenges of real-time quality control
International standards and harmonization of requirements
Approaches to radiopharmaceuticals synthesis: novel synthesis methods, use of microreactors, automated systems
Advancements in radiopharmaceutical quality control: automated control systems, new analytical techniques
Logistical solutions for radiopharmaceuticals delivery: drones, specialized transport, regional manufacturing centers
Radiation safety and waste management
Practical aspects and case studies:
Revision of GMP requirements on radiopharmaceutical manufacturing
Inspection of radiopharmaceutical manufacturing facilities
Common deficiencies identified during inspections of radiopharmaceutical manufacturers
Examples of successful quality system implementation
Continuous Professional Development: New Horizons for Pharmaceutical Inspectors. Detecting the Invisible for Flawless Compliance.
Inspection methodologies for manufacturers, regulator’s experience
Development of Inspection approaches: how methodologies have changed over time under the influence of technological progress and emerging production challenges?
Role of risk-based approach: how do the regulators prioritize inspections and adjust strategies to different types of manufacturing and products?
Inspection process digitalization: use of digital tools, remote monitoring, and data analytics to improve efficiency and effectiveness of audits
International cooperation and standards harmonization: experience of information sharing and exchange of best practices among national regulatory authorities
Collaboration with manufacturers: how to make a constructive dialogue that promotes product quality and safety rather than focusing solely on control?
Inspections in the context of global supply chains: challenges and aspects of quality and safety control of products manufactured in countries with different legislation
Root cause analysis of deficiencies and development of preventive measures: how to use inspection results to prevent future violations
Inspection impact on manufacturing innovations: do the regulatory requirements foster the development of new technologies and improvement of manufacturing processes?
Evaluation of effectiveness of inspection methodologies: how to measure the impact of inspections and their contribution in customer safety
Application of Big Data to improve inspection efficiency
Monitoring and control systems: inspector’s role
Inspections of quality management systems (QMS) created on cloud platforms and electronic batch record (EBR): regulator expectations, data integrity, system validation, and inspector real-time access to records
Application of Artificial Intelligence in Pharmaceutical Inspections: Practical Experience
Inspector training and professional development: continuous learning and adjustment to change
Path to professionalism: hiring, training and qualification procedure for inspectors of pharmaceutical
Key competences of modern pharmaceutical inspector: a detailed review of essential knowledge, skills, and interpersonal skills relevant to the changeable regulatory environment
Implementation of international standards into inspector’s training and education system: comparison of national and international approaches, examples of successful conformation, identified challenges and ways to overcome them
Digitalization of inspector qualification and authorization processes: opportunities and risks. Overview of electronic systems for certification, competency monitoring, data storage, and cybersecurity issues.
Use of simulation training and case study analysis in the training of pharmaceutical inspectors. Advantages of hands-on learning, scenario development, results assessment, and examples of successful programs. Metrics and performance indicators for pharmaceutical inspector training systems. Development of KPIs, methods for assessing knowledge, impact of training on inspection quality, and long-term outcomes.
Approaches to forming inspection teams: balancing experience, competences, and independence. Methodologies on building a team, rotation, specifics of facility, and conflict of interest prevention.
Time management and prioritization: effective planning of inspection activities under resource constraints.
Mental resilience and stress management: how to handle pressure and maintain objectivity in challenging situations
The role of quality system in ensuring independence and objectivity of pharmaceutical inspectorate. Corruption prevention mechanisms, impartiality, internal audit, and risk management.
Professional burnout among inspectors: causes, prevention, and support methods. Psychological aspects of job, job stressors, support programs, mentoring, and soft skills development.
Differences in the organizational approaches of local and international pharmaceutical inspections
Information Session, November 17
Risk management: preventing negative impacts and ensuring quality
Management of Interaction with Contract Organisations: From Selection to Implementation
Challenges Faced by Regulatory Authorities in the Context of Rapid Technology Transfer in Global Manufacturing Networks: Alignment, Knowledge Management, and Inspection Coordination.
Minimisation of the Risk of Intellectual Property Leakage when Working with Contract Organisations (RQR).
Assessment and Management of Risks Associated with the Geographical Location of Contract Organisations.
Comprehensive Audit of a Contract Manufacturing Site.
Globalisation of the Manufacturing Supply Chain. Optimisation of Agreements between Parties. Challenges of Control and Inspection.
Batch Release: Review of Successful Case Studies.
Organisation and Management of Toll Manufacturing: Advantages and Challenges.
Logistics and Supply Chain Management in Toll Manufacturing.
International Toll Manufacturing: Specifics and Perspectives.
Risk Management with Respect to Source Materials and Excipients.
Risk Management in the Manufacture of Medicinal Products.
Reduction of administrative barriers and costs for business.
Simplification of licensing, registration and permitting procedures.
Reduction of the number and scope of mandatory requirements.
Regulatory oversight in the context of accelerated drug approval and rapid technology transfer: ensuring GMP compliance while maintaining timely patient access to medicinal products.
Optimisation of control and supervisory activities.
Creation of favourable conditions for business development.
Business–government interaction in the development and application of import licensing norms: dialogue and partnership.
Comparative analysis of import licensing systems in different countries: lessons for improving national legislation.
The "Smart Regulation" paradigm: principles, instruments and administrative burden reduction.
From compliance to simplification of formalities: new approaches to business–regulator interaction.
Exhibition
G2G, B2G, B2B meetings
Good regulatory practice: harmonizing and strengthening regulatory systems for medicinal products
Implementing good regulatory practice: pathways for process optimization and increasing regulatory efficiency
International experience in reforming the regulatory system based on good regulatory practice approaches: pathways and prospects
Flexible regulatory environment: ensuring timely response to emerging risks and challenges
Transparency as a foundation for reliance and cooperation: path to regulatory excellence
Transparency, participation and accessibility: a comprehensive strategy for ensuring transparency in regulation
Aligning best global practices with national standards
Implementation of guidelines of international organizations to improve regulatory processes
Multifaceted approach to regulatory effectiveness science, risk assessment, and international cooperation to achieve public health objectives
Stakeholder engagement in regulatory process:
Mechanisms for public consultation on draft laws and regulations
Consultations with businesses, expert communities, and civil society
Launching platforms for dialogue and feedback
Raising awareness of regulatory changes
Digitalization of regulatory processes:
Development of common platforms to submit documents and receive authorization
Artificial Intelligence for regulatory risk analysis and forecasting
Automation of compliance checks and monitoring
Ensuring accessibility and user-friendliness of digital services for business
Regulatory Session, November 16
Current regulatory approaches: experience and future perspectives
Manufacturing Regulatory Aspects of High-Tech Medicinal Products and Blood Products.
Regulatory strategies for CAR-T: global approaches and local differences
Regulatory aspects of plasma collection and plasma testing for blood manufacturing: challenges and solutions
Certification of plasma master files
Expert sessions, November 16-17
Good Regulatory Practice: Modern Approaches
1. Digital Transformation of Import Licensing: From Paper-Based Document Flow to Electronic Platforms and Blockchain Solutions.
2. Harmonisation of National Licensing Systems with International Trade Agreements: Experience and Best Practices.
3. The Role of Import Licensing in Ensuring National Security and Consumer Protection: Contemporary Challenges and Effective Mechanisms.
4. Impact of Regional Trade Blocs on Import Licensing Practices: Unification or Diversification of Approaches.
5. Import Licensing: Barrier or Necessity?
6. Use of Data and Analytics for Optimisation of Import Licensing Processes: Risk Prediction and Efficiency Enhancement.
Technology: advancement and development
Advanced Therapy Medicinal Products: manufacturing approaches and quality control
Environmentally sustainable culture media: innovations when using renewable resources and waste minimization in culture media production, and their impact on green biotechnology
New sources of nutrient components: investigating alternative sources of amino acids, vitamins, and growth factors of non-animal origin to enhance the safety and ethical standards of cell technologies
Specifics of CAR-T manufacturing inspection
Inspection of plasma centers
Cross-contamination control, comparability, and lifecycle management in the production of gene and cell therapy products: key inspection areas and regulatory expectations
Inspectorate oversight of personalized and ultra-small batch production: approaches to inspecting highly variable drug products and personalized medicinal products
Radiopharmaceuticals: challenges in manufacturing and practical use
Specific challenges and aspects of radiopharmaceutical industry: Radioactive materials: GMP requirements for facilities, equipment, and personnel.
Short shelf life of many radiopharmaceuticals and its impact on logistics and control
Challenges of real-time quality control
International standards and harmonization of requirements
Approaches to radiopharmaceuticals synthesis: novel synthesis methods, use of microreactors, automated systems
Advancements in radiopharmaceutical quality control: automated control systems, new analytical techniques
Logistical solutions for radiopharmaceuticals delivery: drones, specialized transport, regional manufacturing centers
Radiation safety and waste management
Practical aspects and case studies:
Revision of GMP requirements on radiopharmaceutical manufacturing
Inspection of radiopharmaceutical manufacturing facilities
Common deficiencies identified during inspections of radiopharmaceutical manufacturers
Examples of successful quality system implementation
Continuous Professional Development: New Horizons for Pharmaceutical Inspectors. Detecting the Invisible for Flawless Compliance.
Inspection methodologies for manufacturers, regulator’s experience
Development of Inspection approaches: how methodologies have changed over time under the influence of technological progress and emerging production challenges?
Role of risk-based approach: how do the regulators prioritize inspections and adjust strategies to different types of manufacturing and products?
Inspection process digitalization: use of digital tools, remote monitoring, and data analytics to improve efficiency and effectiveness of audits
International cooperation and standards harmonization: experience of information sharing and exchange of best practices among national regulatory authorities
Collaboration with manufacturers: how to make a constructive dialogue that promotes product quality and safety rather than focusing solely on control?
Inspections in the context of global supply chains: challenges and aspects of quality and safety control of products manufactured in countries with different legislation
Root cause analysis of deficiencies and development of preventive measures: how to use inspection results to prevent future violations
Inspection impact on manufacturing innovations: do the regulatory requirements foster the development of new technologies and improvement of manufacturing processes?
Evaluation of effectiveness of inspection methodologies: how to measure the impact of inspections and their contribution in customer safety
Application of Big Data to improve inspection efficiency
Monitoring and control systems: inspector’s role
Inspections of quality management systems (QMS) created on cloud platforms and electronic batch record (EBR): regulator expectations, data integrity, system validation, and inspector real-time access to records
Application of Artificial Intelligence in Pharmaceutical Inspections: Practical Experience
Inspector training and professional development: continuous learning and adjustment to change
Path to professionalism: hiring, training and qualification procedure for inspectors of pharmaceutical
Key competences of modern pharmaceutical inspector: a detailed review of essential knowledge, skills, and interpersonal skills relevant to the changeable regulatory environment
Implementation of international standards into inspector’s training and education system: comparison of national and international approaches, examples of successful conformation, identified challenges and ways to overcome them
Digitalization of inspector qualification and authorization processes: opportunities and risks. Overview of electronic systems for certification, competency monitoring, data storage, and cybersecurity issues.
Use of simulation training and case study analysis in the training of pharmaceutical inspectors. Advantages of hands-on learning, scenario development, results assessment, and examples of successful programs. Metrics and performance indicators for pharmaceutical inspector training systems. Development of KPIs, methods for assessing knowledge, impact of training on inspection quality, and long-term outcomes.
Approaches to forming inspection teams: balancing experience, competences, and independence. Methodologies on building a team, rotation, specifics of facility, and conflict of interest prevention.
Time management and prioritization: effective planning of inspection activities under resource constraints.
Mental resilience and stress management: how to handle pressure and maintain objectivity in challenging situations
The role of quality system in ensuring independence and objectivity of pharmaceutical inspectorate. Corruption prevention mechanisms, impartiality, internal audit, and risk management.
Professional burnout among inspectors: causes, prevention, and support methods. Psychological aspects of job, job stressors, support programs, mentoring, and soft skills development.
Differences in the organizational approaches of local and international pharmaceutical inspections
Information Session, November 17
Risk management: preventing negative impacts and ensuring quality
Management of Interaction with Contract Organisations: From Selection to Implementation
Challenges Faced by Regulatory Authorities in the Context of Rapid Technology Transfer in Global Manufacturing Networks: Alignment, Knowledge Management, and Inspection Coordination.
Minimisation of the Risk of Intellectual Property Leakage when Working with Contract Organisations (RQR).
Assessment and Management of Risks Associated with the Geographical Location of Contract Organisations.
Comprehensive Audit of a Contract Manufacturing Site.
Globalisation of the Manufacturing Supply Chain. Optimisation of Agreements between Parties. Challenges of Control and Inspection.
Batch Release: Review of Successful Case Studies.
Organisation and Management of Toll Manufacturing: Advantages and Challenges.
Logistics and Supply Chain Management in Toll Manufacturing.
International Toll Manufacturing: Specifics and Perspectives.
Risk Management with Respect to Source Materials and Excipients.
Risk Management in the Manufacture of Medicinal Products.
Reduction of administrative barriers and costs for business.
Simplification of licensing, registration and permitting procedures.
Reduction of the number and scope of mandatory requirements.
Regulatory oversight in the context of accelerated drug approval and rapid technology transfer: ensuring GMP compliance while maintaining timely patient access to medicinal products.
Optimisation of control and supervisory activities.
Creation of favourable conditions for business development.
Business–government interaction in the development and application of import licensing norms: dialogue and partnership.
Comparative analysis of import licensing systems in different countries: lessons for improving national legislation.
The "Smart Regulation" paradigm: principles, instruments and administrative burden reduction.
From compliance to simplification of formalities: new approaches to business–regulator interaction.
Exhibition
G2G, B2G, B2B meetings
Архитектура программы 3-го Международного форума фармацевтических инспекторатов
16-17 ноября 2026
Ханой, Вьетнам
16-17 ноября 2026
Ханой, Вьетнам
Пленарная сессия, 16 ноября
Надлежащая регуляторная практика: гармонизация и укрепление систем регулирования лекарственных средств. Внедрение надлежащей регуляторной практики: пути оптимизации процессов и повышение эффективности регулирования
Международный опыт реформирования регуляторной системы с учетом подходов надлежащей регуляторной практики: Пути и перспективы
Гибкая регуляторная среда: Гарантия своевременного реагирования на новые риски и вызовы.
Прозрачность как фундамент доверия и сотрудничества: Путь к совершенству регулирования
Открытость, участие и доступность: Комплексная стратегия обеспечения прозрачности в регулировании.
Адаптация лучших мировых практик к национальным условиям.
Применение рекомендаций международных организаций для совершенствования процессов регулирования
Комплексный подход к регуляторной эффективности: Наука, оценка рисков и международное сотрудничество для достижения целей общественного здравоохранения
Вовлечение заинтересованных сторон в процесс регулирования:
Механизмы общественного обсуждения законопроектов и нормативных актов.
Консультации с представителями бизнеса, экспертного сообщества и гражданского общества.
Создание площадок для диалога и обратной связи.
Повышение осведомленности о регуляторных изменениях.
Цифровизация регуляторных процессов:
Создание единых платформ для подачи документов и получения разрешений.
Использование искусственного интеллекта для анализа и прогнозирования регуляторных рисков.
Автоматизация проверок и мониторинга соблюдения требований.
Обеспечение доступности и удобства использования цифровых сервисов для бизнеса.
Регуляторная сессия, 16 ноября
Современные подходы к регулированию: опыт и перспективы
Особенности регулирования производства высокотехнологичных лекарственных препаратов и препаратов крови.
Регуляторные стратегии для CAR-T: Глобальные подходы и локальные нюансы.
Регуляторные аспекты сбора и тестирования плазмы для производства крови: Вызовы и решения.
Сертификация плазма мастер-файлов
Экспертные сессии, 16-17 ноября
Надлежащая регуляторная практика: современные подходы
Цифровая трансформация лицензирования импорта: от бумажного документооборота к электронным платформам и блокчейн-решениям.
Гармонизация национальных систем лицензирования с международными торговыми соглашениями: опыт и лучшие практики.
Роль лицензирования импорта в обеспечении национальной безопасности и защите потребителей: современные вызовы и эффективные механизмы.
Влияние региональных торговых блоков на практику лицензирования импорта: унификация или диверсификация подходов.
Лицензирование импорта: барьер или необходимость
Использование данных и аналитики для оптимизации процессов лицензирования импорта: прогнозирование рисков и повышение эффективности.
Технологии: совершенствование и развитие
Высокотехнологичные лекарственные препараты: подходы к производству и контролю качества
Особенности инспектирования производства CAR-T
Инспектирование плазма-центров
Контроль перекрёстной контаминации, сопоставимость и управление жизненным циклом в производстве препаратов генной и клеточной терапии: ключевые области инспектирования и ожидания регулятора
Надзор со стороны инспектората за персонализированными и сверхмалыми сериями препаратов: подходы к инспектированию высоко вариабельных лекарственных препаратов, ориентированных на конкретного пациента
Радиофарма. Вызовы в практике регулирования и производства
Специфические вызовы и особенности радиофармацевтической отрасли:
Работа с радиоактивными материалами: требования GMP к помещениям, оборудованию, персоналу.
Короткий срок годности многих радиофармпрепаратов и его влияние на логистику и контроль.
Сложность контроля качества в реальном времени.
Международные стандарты и гармонизация требований.
Подходы к синтезу радиофармпрепаратов: Новые методы синтеза, использование микрореакторов, автоматизированные системы.
Развитие методов контроля качества радиофармпрепаратов: Автоматизированные системы контроля, новые аналитические методы.
Логистические решения для доставки радиофармпрепаратов: Дроны, специализированный транспорт, региональные центры производства.
Вопросы радиационной безопасности и утилизации отходов
Практические аспекты и кейсы:
Пересмотр требований GMP к производству радиофармпрепаратов
Особенности инспектирования радиофармпрепаратов.
Разбор типичных несоответствий, выявляемых при инспектировании производителей радиофармпрепаратов.
Примеры успешного внедрения систем качества.
Совершенствование компетенций: новые горизонты для фармацевтических инспекторов. Видеть то, что скрыто, для безупречного результата
Методики инспектирования производителей, опыт регуляторов.
Эволюция подходов к инспектированию: Как менялись методики с течением времени под влиянием технологического прогресса и новых вызовов в производстве?
Роль риск-ориентированного подхода: Как регуляторы определяют приоритеты инспекций и адаптируют свои стратегии к различным типам производств и продукции?
Цифровизация инспекционного процесса: Применение цифровых инструментов, удаленного мониторинга и анализа данных для повышения эффективности и оперативности проверок.
Международное сотрудничество и гармонизация стандартов: Опыт обмена информацией и лучшими практиками между регуляторными органами разных стран.
Взаимодействие с производителями: Как выстроить конструктивный диалог, способствующий повышению качества и безопасности продукции, а не только контролю?
Инспекции в условиях глобальных цепочек поставок: Сложности и особенности контроля качества и безопасности продукции, произведенной в разных юрисдикциях.
Анализ причин несоответствий и разработка превентивных мер: Как использовать результаты инспекций для предотвращения будущих нарушений.
Влияние инспекций на инновации в производстве: Способствуют ли регуляторные требования развитию новых технологий и улучшению производственных процессов?
Оценка эффективности методик инспектирования: Как измерить результативность проводимых проверок и их вклад в обеспечение безопасности потребителей.
Применение больших данных (Big Data) для повышения эффективности инспекций
Создание «систем мониторинга и контроля»: роль инспектора в их эксплуатации
Инспекции систем качества, разработанных на базе облачных платформ (QMS) и электронные платформы досье на серию (EBR): ожидания регулятора, целостность данных, валидация систем и доступ инспекторов к записям в режиме реального времени
Опыт применения ИИ в практике инспектирования
Подготовка и профессиональное развитие инспектора: непрерывное обучение и адаптация к изменениям
Путь к профессионализму: порядок приема, обучения и допуска инспектора фармацевтического инспектората.
Ключевые компетенции современного фармацевтического инспектора: вызовы и требования. Подробный анализ необходимых знаний, навыков и личностных качеств, актуальных в условиях меняющейся регуляторной среды.
Опыт внедрения международных стандартов в систему обучения и подготовки фармацевтических инспекторов. Сравнение национальных и международных подходов, примеры успешной адаптации, выявленные сложности и пути их преодоления.
Цифровизация процесса допуска инспектора к проведению инспектирования: возможности и риски. Обзор использования электронных систем для аттестации, мониторинга квалификации, хранения данных, вопросы кибербезопасности.
Использование симуляционных тренингов и анализ случаев из практики при подготовке фармацевтических инспекторов. Преимущества практического обучения, разработка сценариев, оценка результатов, примеры успешных программ.
Метрики и индикаторы эффективности системы обучения фармацевтических инспекторов. Разработка KPI, методы оценки усвоения материала, влияние обучения на качество инспекций, долгосрочные результаты.
Подходы к формированию инспекционных групп: баланс опыта, специализации и независимости. Методологии формирования команд, ротация, учет специфики инспектируемого объекта, предотвращение конфликта интересов.
Управление временем и приоритетами: Эффективное планирование инспекционной деятельности в условиях ограниченных ресурсов.
Психологическая устойчивость и стресс-менеджмент: Как справляться с давлением и сохранять объективность в сложных ситуациях.
Роль системы качества в обеспечении независимости и объективности фармацевтического инспектората. Механизмы предотвращения коррупции, обеспечения беспристрастности, внутренний аудит, управление рисками.
Профессиональное выгорание инспекторов: причины, профилактика и методы поддержки. Психологические аспекты работы, стресс-факторы, программы поддержки, менторство, развитие soft skills.
Различия в подходах организации локальных и международных фармацевтических инспекций.
Информационные сессии, 17 ноября
Управление рисками: предотвращение негативных последствий и обеспечение качества.
Управление взаимодействием с контрактными организациями:
От выбора до реализации
Вызовы, с которыми сталкиваются регуляторные органы в условиях быстрого трансфера технологий в глобальных производственных сетях: согласованность, управление знаниями и координация инспекций.
Минимизация риска утечки интеллектуальной собственности при работе с КП (RQR).
Оценка и управление рисками, связанными с географическим положением КП.
Комплексный аудит контрактной производственной площадки
Глобализация производственной цепи. Оптимизация соглашений между сторонами. Вызовы контроля и инспектирования.
Выпускающий контроль: Изучение успешных кейсов
Организация и управление толлинговым производством: Преимущества и вызовы.
Логистика и управление цепочками поставок в толлинговом производстве.
Международный толлинг: особенности и перспективы.
Управление рисками в отношении исходного сырья и вспомогательных материалов.
Управление рисками при производстве лекарственных средств.
Снижение административных барьеров и издержек для бизнеса.
Упрощение процедур лицензирования, регистрации и получения разрешений.
Сокращение количества и объема обязательных требований.
Надзор со стороны регулятора при ускоренном одобрении препаратов и быстром трансфере технологий: соблюдение требований GMP при обеспечении своевременного доступа пациентов к препаратам.
Оптимизация контрольно-надзорной деятельности.
Создание благоприятных условий для развития предпринимательства.
Взаимодействие бизнеса и государства в процессе разработки и применения норм лицензирования импорта: диалог и партнерство.
Сравнительный анализ систем лицензирования импорта в различных странах: уроки для совершенствования национального законодательства.
Парадигма «Умное регулирование»: Принципы инструментов и снижения административной нагрузки».
От соблюдения требований к упрощению формальностей: новые подходы к взаимодействию бизнеса и регулятора.
Выставка
Встречи: G2G, B2G, B2B
Надлежащая регуляторная практика: гармонизация и укрепление систем регулирования лекарственных средств. Внедрение надлежащей регуляторной практики: пути оптимизации процессов и повышение эффективности регулирования
Международный опыт реформирования регуляторной системы с учетом подходов надлежащей регуляторной практики: Пути и перспективы
Гибкая регуляторная среда: Гарантия своевременного реагирования на новые риски и вызовы.
Прозрачность как фундамент доверия и сотрудничества: Путь к совершенству регулирования
Открытость, участие и доступность: Комплексная стратегия обеспечения прозрачности в регулировании.
Адаптация лучших мировых практик к национальным условиям.
Применение рекомендаций международных организаций для совершенствования процессов регулирования
Комплексный подход к регуляторной эффективности: Наука, оценка рисков и международное сотрудничество для достижения целей общественного здравоохранения
Вовлечение заинтересованных сторон в процесс регулирования:
Механизмы общественного обсуждения законопроектов и нормативных актов.
Консультации с представителями бизнеса, экспертного сообщества и гражданского общества.
Создание площадок для диалога и обратной связи.
Повышение осведомленности о регуляторных изменениях.
Цифровизация регуляторных процессов:
Создание единых платформ для подачи документов и получения разрешений.
Использование искусственного интеллекта для анализа и прогнозирования регуляторных рисков.
Автоматизация проверок и мониторинга соблюдения требований.
Обеспечение доступности и удобства использования цифровых сервисов для бизнеса.
Регуляторная сессия, 16 ноября
Современные подходы к регулированию: опыт и перспективы
Особенности регулирования производства высокотехнологичных лекарственных препаратов и препаратов крови.
Регуляторные стратегии для CAR-T: Глобальные подходы и локальные нюансы.
Регуляторные аспекты сбора и тестирования плазмы для производства крови: Вызовы и решения.
Сертификация плазма мастер-файлов
Экспертные сессии, 16-17 ноября
Надлежащая регуляторная практика: современные подходы
Цифровая трансформация лицензирования импорта: от бумажного документооборота к электронным платформам и блокчейн-решениям.
Гармонизация национальных систем лицензирования с международными торговыми соглашениями: опыт и лучшие практики.
Роль лицензирования импорта в обеспечении национальной безопасности и защите потребителей: современные вызовы и эффективные механизмы.
Влияние региональных торговых блоков на практику лицензирования импорта: унификация или диверсификация подходов.
Лицензирование импорта: барьер или необходимость
Использование данных и аналитики для оптимизации процессов лицензирования импорта: прогнозирование рисков и повышение эффективности.
Технологии: совершенствование и развитие
Высокотехнологичные лекарственные препараты: подходы к производству и контролю качества
Особенности инспектирования производства CAR-T
Инспектирование плазма-центров
Контроль перекрёстной контаминации, сопоставимость и управление жизненным циклом в производстве препаратов генной и клеточной терапии: ключевые области инспектирования и ожидания регулятора
Надзор со стороны инспектората за персонализированными и сверхмалыми сериями препаратов: подходы к инспектированию высоко вариабельных лекарственных препаратов, ориентированных на конкретного пациента
Радиофарма. Вызовы в практике регулирования и производства
Специфические вызовы и особенности радиофармацевтической отрасли:
Работа с радиоактивными материалами: требования GMP к помещениям, оборудованию, персоналу.
Короткий срок годности многих радиофармпрепаратов и его влияние на логистику и контроль.
Сложность контроля качества в реальном времени.
Международные стандарты и гармонизация требований.
Подходы к синтезу радиофармпрепаратов: Новые методы синтеза, использование микрореакторов, автоматизированные системы.
Развитие методов контроля качества радиофармпрепаратов: Автоматизированные системы контроля, новые аналитические методы.
Логистические решения для доставки радиофармпрепаратов: Дроны, специализированный транспорт, региональные центры производства.
Вопросы радиационной безопасности и утилизации отходов
Практические аспекты и кейсы:
Пересмотр требований GMP к производству радиофармпрепаратов
Особенности инспектирования радиофармпрепаратов.
Разбор типичных несоответствий, выявляемых при инспектировании производителей радиофармпрепаратов.
Примеры успешного внедрения систем качества.
Совершенствование компетенций: новые горизонты для фармацевтических инспекторов. Видеть то, что скрыто, для безупречного результата
Методики инспектирования производителей, опыт регуляторов.
Эволюция подходов к инспектированию: Как менялись методики с течением времени под влиянием технологического прогресса и новых вызовов в производстве?
Роль риск-ориентированного подхода: Как регуляторы определяют приоритеты инспекций и адаптируют свои стратегии к различным типам производств и продукции?
Цифровизация инспекционного процесса: Применение цифровых инструментов, удаленного мониторинга и анализа данных для повышения эффективности и оперативности проверок.
Международное сотрудничество и гармонизация стандартов: Опыт обмена информацией и лучшими практиками между регуляторными органами разных стран.
Взаимодействие с производителями: Как выстроить конструктивный диалог, способствующий повышению качества и безопасности продукции, а не только контролю?
Инспекции в условиях глобальных цепочек поставок: Сложности и особенности контроля качества и безопасности продукции, произведенной в разных юрисдикциях.
Анализ причин несоответствий и разработка превентивных мер: Как использовать результаты инспекций для предотвращения будущих нарушений.
Влияние инспекций на инновации в производстве: Способствуют ли регуляторные требования развитию новых технологий и улучшению производственных процессов?
Оценка эффективности методик инспектирования: Как измерить результативность проводимых проверок и их вклад в обеспечение безопасности потребителей.
Применение больших данных (Big Data) для повышения эффективности инспекций
Создание «систем мониторинга и контроля»: роль инспектора в их эксплуатации
Инспекции систем качества, разработанных на базе облачных платформ (QMS) и электронные платформы досье на серию (EBR): ожидания регулятора, целостность данных, валидация систем и доступ инспекторов к записям в режиме реального времени
Опыт применения ИИ в практике инспектирования
Подготовка и профессиональное развитие инспектора: непрерывное обучение и адаптация к изменениям
Путь к профессионализму: порядок приема, обучения и допуска инспектора фармацевтического инспектората.
Ключевые компетенции современного фармацевтического инспектора: вызовы и требования. Подробный анализ необходимых знаний, навыков и личностных качеств, актуальных в условиях меняющейся регуляторной среды.
Опыт внедрения международных стандартов в систему обучения и подготовки фармацевтических инспекторов. Сравнение национальных и международных подходов, примеры успешной адаптации, выявленные сложности и пути их преодоления.
Цифровизация процесса допуска инспектора к проведению инспектирования: возможности и риски. Обзор использования электронных систем для аттестации, мониторинга квалификации, хранения данных, вопросы кибербезопасности.
Использование симуляционных тренингов и анализ случаев из практики при подготовке фармацевтических инспекторов. Преимущества практического обучения, разработка сценариев, оценка результатов, примеры успешных программ.
Метрики и индикаторы эффективности системы обучения фармацевтических инспекторов. Разработка KPI, методы оценки усвоения материала, влияние обучения на качество инспекций, долгосрочные результаты.
Подходы к формированию инспекционных групп: баланс опыта, специализации и независимости. Методологии формирования команд, ротация, учет специфики инспектируемого объекта, предотвращение конфликта интересов.
Управление временем и приоритетами: Эффективное планирование инспекционной деятельности в условиях ограниченных ресурсов.
Психологическая устойчивость и стресс-менеджмент: Как справляться с давлением и сохранять объективность в сложных ситуациях.
Роль системы качества в обеспечении независимости и объективности фармацевтического инспектората. Механизмы предотвращения коррупции, обеспечения беспристрастности, внутренний аудит, управление рисками.
Профессиональное выгорание инспекторов: причины, профилактика и методы поддержки. Психологические аспекты работы, стресс-факторы, программы поддержки, менторство, развитие soft skills.
Различия в подходах организации локальных и международных фармацевтических инспекций.
Информационные сессии, 17 ноября
Управление рисками: предотвращение негативных последствий и обеспечение качества.
Управление взаимодействием с контрактными организациями:
От выбора до реализации
Вызовы, с которыми сталкиваются регуляторные органы в условиях быстрого трансфера технологий в глобальных производственных сетях: согласованность, управление знаниями и координация инспекций.
Минимизация риска утечки интеллектуальной собственности при работе с КП (RQR).
Оценка и управление рисками, связанными с географическим положением КП.
Комплексный аудит контрактной производственной площадки
Глобализация производственной цепи. Оптимизация соглашений между сторонами. Вызовы контроля и инспектирования.
Выпускающий контроль: Изучение успешных кейсов
Организация и управление толлинговым производством: Преимущества и вызовы.
Логистика и управление цепочками поставок в толлинговом производстве.
Международный толлинг: особенности и перспективы.
Управление рисками в отношении исходного сырья и вспомогательных материалов.
Управление рисками при производстве лекарственных средств.
Снижение административных барьеров и издержек для бизнеса.
Упрощение процедур лицензирования, регистрации и получения разрешений.
Сокращение количества и объема обязательных требований.
Надзор со стороны регулятора при ускоренном одобрении препаратов и быстром трансфере технологий: соблюдение требований GMP при обеспечении своевременного доступа пациентов к препаратам.
Оптимизация контрольно-надзорной деятельности.
Создание благоприятных условий для развития предпринимательства.
Взаимодействие бизнеса и государства в процессе разработки и применения норм лицензирования импорта: диалог и партнерство.
Сравнительный анализ систем лицензирования импорта в различных странах: уроки для совершенствования национального законодательства.
Парадигма «Умное регулирование»: Принципы инструментов и снижения административной нагрузки».
От соблюдения требований к упрощению формальностей: новые подходы к взаимодействию бизнеса и регулятора.
Выставка
Встречи: G2G, B2G, B2B
III Foro Internacional de Inspectorados Farmacéuticos (IFPI). Arquitectura del Programa Empresarial
Hanói, Vietnam
Hanói, Vietnam
Sesión Plenaria – 16 de noviembre
Buenas Prácticas Regulatorias: armonización y fortalecimiento de los sistemas de regulación de medicamentos. Implementación de las Buenas Prácticas Regulatorias: vías para la optimización de procesos y el aumento de la eficiencia regulatoria
Experiencia internacional en la reforma del sistema regulatorio basada en enfoques de Buenas Prácticas Regulatorias: vías y perspectivas
Entorno regulatorio flexible: garantía de una respuesta oportuna a los riesgos y desafíos emergentes
Transparencia como base para la confianza y la cooperación: camino hacia la excelencia regulatoria
Transparencia, participación y accesibilidad: una estrategia integral para garantizar la transparencia en la regulación
Armonización de las mejores prácticas globales con las normas nacionales
Implementación de directrices de organizaciones internacionales para la mejora de los procesos regulatorios
Enfoque multidimensional de la eficacia regulatoria: ciencia, evaluación de riesgos y cooperación internacional para alcanzar los objetivos de salud pública
Participación de las partes interesadas en el proceso regulatorio:
Mecanismos de consulta pública sobre proyectos de leyes y reglamentos
Consultas con el sector empresarial, comunidades de expertos y la sociedad civil
Creación de plataformas para el diálogo y la retroalimentación
Sensibilización sobre los cambios regulatorios
Digitalización de los procesos regulatorios:
Desarrollo de plataformas comunes para la presentación de documentos y la obtención de autorizaciones
Inteligencia Artificial para el análisis y la previsión de riesgos regulatorios
Automatización de los controles de cumplimiento y el seguimiento
Garantía de accesibilidad y facilidad de uso de los servicios digitales para el sector empresarial
Sesión Regulatoria – 16 de noviembre
Enfoques regulatorios actuales: experiencia y perspectivas futuras
Aspectos regulatorios de fabricación de medicamentos de alta tecnología y hemoderivados
Estrategias regulatorias para CAR-T: enfoques globales y diferencias locales
Aspectos regulatorios de la recolección de plasma y pruebas de plasma para la fabricación de hemoderivados: desafíos y soluciones
Certificación de expedientes maestros de plasma
Sesiones de expertos – 16 y 17 de noviembre
Buenas Prácticas Regulatorias: Enfoques Modernos
1. Transformación digital de las licencias de importación: del flujo documental en papel a las plataformas electrónicas y soluciones basadas en cadena de bloques.
2. Armonización de los sistemas nacionales de licencias con los acuerdos comerciales internacionales: experiencia y mejores prácticas.
3. Función de las licencias de importación en la garantía de la seguridad nacional y la protección de los consumidores: desafíos contemporáneos y mecanismos eficaces.
4. Impacto de los bloques comerciales regionales en las prácticas de concesión de licencias de importación: ¿unificación o diversificación de enfoques?
5. Licencias de importación: ¿barrera o necesidad?
6. Uso de datos y análisis para la optimización de los procesos de concesión de licencias de importación: predicción de riesgos y mejora de la eficiencia.
Tecnología: avances y desarrollo
Productos Médicos de Terapia Avanzada: enfoques de fabricación y control de calidad
Medios de cultivo sostenibles con el medio ambiente: innovaciones en el uso de recursos renovables y minimización de residuos en la producción de medios de cultivo, y su impacto en la biotecnología verde
Nuevas fuentes de componentes nutritivos: investigación de fuentes alternativas de aminoácidos, vitaminas y factores de crecimiento de origen no animal para mejorar la seguridad y los estándares éticos de las tecnologías celulares
Particularidades de la inspección de la fabricación de CAR-T
Inspección de centros de plasma
Control de contaminación cruzada, comparabilidad y gestión del ciclo de vida en la producción de productos de terapia génica y celular: áreas clave de inspección y expectativas regulatorias
Supervisión por parte del inspectorado de la producción personalizada y de lotes ultrapequeños: enfoques para la inspección de productos farmacéuticos de alta variabilidad y productos medicinales personalizados
Radiofármacos: desafíos en la fabricación y el uso práctico
Desafíos específicos y aspectos de la industria radiofarmacéutica:
Materiales radiactivos: requisitos de GMP para instalaciones, equipos y personal
Corta vida útil de muchos radiofármacos y su impacto en la logística y el control
Desafíos del control de calidad en tiempo real
Estándares internacionales y armonización de requisitos
Enfoques para la síntesis de radiofármacos: nuevos métodos de síntesis, uso de microrreactores, sistemas automatizados
Avances en el control de calidad de radiofármacos: sistemas de control automatizados, nuevas técnicas analíticas
Soluciones logísticas para la entrega de radiofármacos: drones, transporte especializado, centros de fabricación regionales
Seguridad radiológica y gestión de residuos
Aspectos prácticos y casos de estudio:
Revisión de los requisitos de GMP para la fabricación de radiofármacos
Ejemplos de implementación exitosa de sistemas de calidad
Desarrollo Profesional Continuo: Nuevos Horizontes para los Inspectores Farmacéuticos. Detectando lo Invisible para un Cumplimiento Impecable.
Metodologías de inspección para fabricantes: experiencia del regulador
Desarrollo de enfoques de inspección: ¿cómo han cambiado las metodologías a lo largo del tiempo bajo la influencia del progreso tecnológico y los desafíos emergentes en la producción?
Papel del enfoque basado en riesgos: ¿cómo priorizan los reguladores las inspecciones y ajustan las estrategias a los diferentes tipos de fabricación y productos?
Digitalización del proceso de inspección: uso de herramientas digitales, monitoreo remoto y análisis de datos para mejorar la eficiencia y eficacia de las auditorías
Cooperación internacional y armonización de estándares: experiencia en el intercambio de información y buenas prácticas entre autoridades reguladoras nacionales
Colaboración con los fabricantes: ¿cómo establecer un diálogo constructivo que promueva la calidad y seguridad del producto en lugar de centrarse únicamente en el control
Inspecciones en el contexto de las cadenas de suministro globales: desafíos y aspectos del control de calidad y seguridad de productos fabricados en países con legislaciones diferentes
Análisis de causas raíz de las deficiencias y desarrollo de medidas preventivas: ¿cómo utilizar los resultados de las inspecciones para prevenir futuras infracciones?
Impacto de las inspecciones en la innovación en la fabricación: ¿los requisitos regulatorios fomentan el desarrollo de nuevas tecnologías y la mejora de los procesos de producción?
Evaluación de la eficacia de las metodologías de inspección: ¿cómo medir el impacto de las inspecciones y su contribución a la seguridad del paciente?
Aplicación de Big Data para mejorar la eficiencia de las inspecciones
Sistemas de monitoreo y control: papel del inspector
Inspecciones de los sistemas de gestión de calidad (QMS) alojados en plataformas en la nube y registro de lotes electrónico (EBR): expectativas del regulador, integridad de los datos, validación del sistema y acceso en tiempo real del inspector a los registros
Aplicación de la Inteligencia Artificial en las inspecciones farmacéuticas: experiencia práctica
Formación y desarrollo profesional del inspector: aprendizaje continuo y adaptación al cambio
Camino hacia la profesionalidad: contratación, formación y procedimiento de cualificación de los inspectores farmacéuticos
Competencias clave del inspector farmacéutico moderno: revisión detallada de los conocimientos esenciales, habilidades técnicas e interpersonales relevantes para el cambiante entorno regulatorio
Implementación de estándares internacionales en el sistema de formación y educación de inspectores: comparación de enfoques nacionales e internacionales, ejemplos de conformación exitosa, desafíos identificados y formas de superarlos
Digitalización de los procesos de cualificación y autorización de inspectores: oportunidades y riesgos. Panorama de los sistemas electrónicos para la certificación, monitoreo de competencias, almacenamiento de datos y cuestiones de ciberseguridad
Uso de entrenamiento con simulación y análisis de casos de estudio en la formación de inspectores farmacéuticos. Ventajas del aprendizaje práctico, desarrollo de escenarios, evaluación de resultados y ejemplos de programas exitosos
Métricas e indicadores de rendimiento para los sistemas de formación de inspectores farmacéuticos. Desarrollo de KPIs, métodos para la evaluación de conocimientos, impacto de la formación en la calidad de las inspecciones y resultados a largo plazo
Enfoques para la formación de equipos de inspección: equilibrio entre experiencia, competencias e independencia. Metodologías para la conformación de equipos, rotación, particularidades de las instalaciones y prevención de conflictos de interés
Gestión del tiempo y priorización: planificación eficaz de las actividades de inspección en condiciones de recursos limitados
Resiliencia mental y gestión del estrés: cómo manejar la presión y mantener la objetividad en situaciones desafiantes
El papel del sistema de calidad en la garantía de la independencia y objetividad del inspectorado farmacéutico. Mecanismos de prevención de la corrupción, imparcialidad, auditoría interna y gestión de riesgos
Agotamiento profesional entre los inspectores: causas, prevención y métodos de apoyo. Aspectos psicológicos del trabajo, factores estresantes laborales, programas de apoyo, mentoría y desarrollo de habilidades blandas
Diferencias en los enfoques organizativos de las inspecciones farmacéuticas locales e internacionales
Sesión Informativa – 17 de noviembre
Gestión de riesgos: prevención de impactos negativos y garantía de calidad
Gestión de la interacción con organizaciones contratadas: desde la selección hasta la implementación
Desafíos que enfrentan las autoridades reguladoras en el contexto de la rápida transferencia de tecnología en las redes de fabricación globales: alineación, gestión del conocimiento y coordinación de inspecciones
Minimización del riesgo de fuga de propiedad intelectual al trabajar con organizaciones contratadas (RQR)
Evaluación y gestión de los riesgos asociados con la ubicación geográfica de las organizaciones contratadas
Auditoría integral de un sitio de fabricación por contrato
Globalización de la cadena de suministro de fabricación.
Optimización de los acuerdos entre las partes.
Desafíos de control e inspección
Liberación de lotes: revisión de casos de estudio exitosos
Organización y gestión de la fabricación por contrato (toll manufacturing): ventajas y desafíos
Logística y gestión de la cadena de suministro en la fabricación por contrato
Fabricación internacional por contrato: particularidades y perspectivas
Gestión de riesgos en relación con materiales de partida y excipientes
Gestión de riesgos en la fabricación de medicamentos
Reducción de barreras administrativas y costos para el sector empresarial
Simplificación de los procedimientos de licencias, registro y autorizaciones
Reducción del número y alcance de los requisitos obligatorios
Supervisión regulatoria en el contexto de la aprobación acelerada de medicamentos y la rápida transferencia de tecnología: garantía del cumplimiento de GMP manteniendo el acceso oportuno de los pacientes a los medicamentos
Optimización de las actividades de control y supervisión
Creación de condiciones favorables para el desarrollo empresarial
Interacción entre el sector empresarial y el gobierno en el desarrollo y aplicación de las normas de licencias de importación: diálogo y colaboración
Análisis comparativo de los sistemas de licencias de importación en diferentes países: lecciones para la mejora de la legislación nacional
El paradigma de la "Regulación Inteligente": principios, instrumentos y reducción de la carga administrativa
Del cumplimiento a la simplificación de formalidades: nuevos enfoques en la interacción entre el sector empresarial y el regulador
Exposición
Reuniones G2G, B2G y B2B
Buenas Prácticas Regulatorias: armonización y fortalecimiento de los sistemas de regulación de medicamentos. Implementación de las Buenas Prácticas Regulatorias: vías para la optimización de procesos y el aumento de la eficiencia regulatoria
Experiencia internacional en la reforma del sistema regulatorio basada en enfoques de Buenas Prácticas Regulatorias: vías y perspectivas
Entorno regulatorio flexible: garantía de una respuesta oportuna a los riesgos y desafíos emergentes
Transparencia como base para la confianza y la cooperación: camino hacia la excelencia regulatoria
Transparencia, participación y accesibilidad: una estrategia integral para garantizar la transparencia en la regulación
Armonización de las mejores prácticas globales con las normas nacionales
Implementación de directrices de organizaciones internacionales para la mejora de los procesos regulatorios
Enfoque multidimensional de la eficacia regulatoria: ciencia, evaluación de riesgos y cooperación internacional para alcanzar los objetivos de salud pública
Participación de las partes interesadas en el proceso regulatorio:
Mecanismos de consulta pública sobre proyectos de leyes y reglamentos
Consultas con el sector empresarial, comunidades de expertos y la sociedad civil
Creación de plataformas para el diálogo y la retroalimentación
Sensibilización sobre los cambios regulatorios
Digitalización de los procesos regulatorios:
Desarrollo de plataformas comunes para la presentación de documentos y la obtención de autorizaciones
Inteligencia Artificial para el análisis y la previsión de riesgos regulatorios
Automatización de los controles de cumplimiento y el seguimiento
Garantía de accesibilidad y facilidad de uso de los servicios digitales para el sector empresarial
Sesión Regulatoria – 16 de noviembre
Enfoques regulatorios actuales: experiencia y perspectivas futuras
Aspectos regulatorios de fabricación de medicamentos de alta tecnología y hemoderivados
Estrategias regulatorias para CAR-T: enfoques globales y diferencias locales
Aspectos regulatorios de la recolección de plasma y pruebas de plasma para la fabricación de hemoderivados: desafíos y soluciones
Certificación de expedientes maestros de plasma
Sesiones de expertos – 16 y 17 de noviembre
Buenas Prácticas Regulatorias: Enfoques Modernos
1. Transformación digital de las licencias de importación: del flujo documental en papel a las plataformas electrónicas y soluciones basadas en cadena de bloques.
2. Armonización de los sistemas nacionales de licencias con los acuerdos comerciales internacionales: experiencia y mejores prácticas.
3. Función de las licencias de importación en la garantía de la seguridad nacional y la protección de los consumidores: desafíos contemporáneos y mecanismos eficaces.
4. Impacto de los bloques comerciales regionales en las prácticas de concesión de licencias de importación: ¿unificación o diversificación de enfoques?
5. Licencias de importación: ¿barrera o necesidad?
6. Uso de datos y análisis para la optimización de los procesos de concesión de licencias de importación: predicción de riesgos y mejora de la eficiencia.
Tecnología: avances y desarrollo
Productos Médicos de Terapia Avanzada: enfoques de fabricación y control de calidad
Medios de cultivo sostenibles con el medio ambiente: innovaciones en el uso de recursos renovables y minimización de residuos en la producción de medios de cultivo, y su impacto en la biotecnología verde
Nuevas fuentes de componentes nutritivos: investigación de fuentes alternativas de aminoácidos, vitaminas y factores de crecimiento de origen no animal para mejorar la seguridad y los estándares éticos de las tecnologías celulares
Particularidades de la inspección de la fabricación de CAR-T
Inspección de centros de plasma
Control de contaminación cruzada, comparabilidad y gestión del ciclo de vida en la producción de productos de terapia génica y celular: áreas clave de inspección y expectativas regulatorias
Supervisión por parte del inspectorado de la producción personalizada y de lotes ultrapequeños: enfoques para la inspección de productos farmacéuticos de alta variabilidad y productos medicinales personalizados
Radiofármacos: desafíos en la fabricación y el uso práctico
Desafíos específicos y aspectos de la industria radiofarmacéutica:
Materiales radiactivos: requisitos de GMP para instalaciones, equipos y personal
Corta vida útil de muchos radiofármacos y su impacto en la logística y el control
Desafíos del control de calidad en tiempo real
Estándares internacionales y armonización de requisitos
Enfoques para la síntesis de radiofármacos: nuevos métodos de síntesis, uso de microrreactores, sistemas automatizados
Avances en el control de calidad de radiofármacos: sistemas de control automatizados, nuevas técnicas analíticas
Soluciones logísticas para la entrega de radiofármacos: drones, transporte especializado, centros de fabricación regionales
Seguridad radiológica y gestión de residuos
Aspectos prácticos y casos de estudio:
Revisión de los requisitos de GMP para la fabricación de radiofármacos
Ejemplos de implementación exitosa de sistemas de calidad
Desarrollo Profesional Continuo: Nuevos Horizontes para los Inspectores Farmacéuticos. Detectando lo Invisible para un Cumplimiento Impecable.
Metodologías de inspección para fabricantes: experiencia del regulador
Desarrollo de enfoques de inspección: ¿cómo han cambiado las metodologías a lo largo del tiempo bajo la influencia del progreso tecnológico y los desafíos emergentes en la producción?
Papel del enfoque basado en riesgos: ¿cómo priorizan los reguladores las inspecciones y ajustan las estrategias a los diferentes tipos de fabricación y productos?
Digitalización del proceso de inspección: uso de herramientas digitales, monitoreo remoto y análisis de datos para mejorar la eficiencia y eficacia de las auditorías
Cooperación internacional y armonización de estándares: experiencia en el intercambio de información y buenas prácticas entre autoridades reguladoras nacionales
Colaboración con los fabricantes: ¿cómo establecer un diálogo constructivo que promueva la calidad y seguridad del producto en lugar de centrarse únicamente en el control
Inspecciones en el contexto de las cadenas de suministro globales: desafíos y aspectos del control de calidad y seguridad de productos fabricados en países con legislaciones diferentes
Análisis de causas raíz de las deficiencias y desarrollo de medidas preventivas: ¿cómo utilizar los resultados de las inspecciones para prevenir futuras infracciones?
Impacto de las inspecciones en la innovación en la fabricación: ¿los requisitos regulatorios fomentan el desarrollo de nuevas tecnologías y la mejora de los procesos de producción?
Evaluación de la eficacia de las metodologías de inspección: ¿cómo medir el impacto de las inspecciones y su contribución a la seguridad del paciente?
Aplicación de Big Data para mejorar la eficiencia de las inspecciones
Sistemas de monitoreo y control: papel del inspector
Inspecciones de los sistemas de gestión de calidad (QMS) alojados en plataformas en la nube y registro de lotes electrónico (EBR): expectativas del regulador, integridad de los datos, validación del sistema y acceso en tiempo real del inspector a los registros
Aplicación de la Inteligencia Artificial en las inspecciones farmacéuticas: experiencia práctica
Formación y desarrollo profesional del inspector: aprendizaje continuo y adaptación al cambio
Camino hacia la profesionalidad: contratación, formación y procedimiento de cualificación de los inspectores farmacéuticos
Competencias clave del inspector farmacéutico moderno: revisión detallada de los conocimientos esenciales, habilidades técnicas e interpersonales relevantes para el cambiante entorno regulatorio
Implementación de estándares internacionales en el sistema de formación y educación de inspectores: comparación de enfoques nacionales e internacionales, ejemplos de conformación exitosa, desafíos identificados y formas de superarlos
Digitalización de los procesos de cualificación y autorización de inspectores: oportunidades y riesgos. Panorama de los sistemas electrónicos para la certificación, monitoreo de competencias, almacenamiento de datos y cuestiones de ciberseguridad
Uso de entrenamiento con simulación y análisis de casos de estudio en la formación de inspectores farmacéuticos. Ventajas del aprendizaje práctico, desarrollo de escenarios, evaluación de resultados y ejemplos de programas exitosos
Métricas e indicadores de rendimiento para los sistemas de formación de inspectores farmacéuticos. Desarrollo de KPIs, métodos para la evaluación de conocimientos, impacto de la formación en la calidad de las inspecciones y resultados a largo plazo
Enfoques para la formación de equipos de inspección: equilibrio entre experiencia, competencias e independencia. Metodologías para la conformación de equipos, rotación, particularidades de las instalaciones y prevención de conflictos de interés
Gestión del tiempo y priorización: planificación eficaz de las actividades de inspección en condiciones de recursos limitados
Resiliencia mental y gestión del estrés: cómo manejar la presión y mantener la objetividad en situaciones desafiantes
El papel del sistema de calidad en la garantía de la independencia y objetividad del inspectorado farmacéutico. Mecanismos de prevención de la corrupción, imparcialidad, auditoría interna y gestión de riesgos
Agotamiento profesional entre los inspectores: causas, prevención y métodos de apoyo. Aspectos psicológicos del trabajo, factores estresantes laborales, programas de apoyo, mentoría y desarrollo de habilidades blandas
Diferencias en los enfoques organizativos de las inspecciones farmacéuticas locales e internacionales
Sesión Informativa – 17 de noviembre
Gestión de riesgos: prevención de impactos negativos y garantía de calidad
Gestión de la interacción con organizaciones contratadas: desde la selección hasta la implementación
Desafíos que enfrentan las autoridades reguladoras en el contexto de la rápida transferencia de tecnología en las redes de fabricación globales: alineación, gestión del conocimiento y coordinación de inspecciones
Minimización del riesgo de fuga de propiedad intelectual al trabajar con organizaciones contratadas (RQR)
Evaluación y gestión de los riesgos asociados con la ubicación geográfica de las organizaciones contratadas
Auditoría integral de un sitio de fabricación por contrato
Globalización de la cadena de suministro de fabricación.
Optimización de los acuerdos entre las partes.
Desafíos de control e inspección
Liberación de lotes: revisión de casos de estudio exitosos
Organización y gestión de la fabricación por contrato (toll manufacturing): ventajas y desafíos
Logística y gestión de la cadena de suministro en la fabricación por contrato
Fabricación internacional por contrato: particularidades y perspectivas
Gestión de riesgos en relación con materiales de partida y excipientes
Gestión de riesgos en la fabricación de medicamentos
Reducción de barreras administrativas y costos para el sector empresarial
Simplificación de los procedimientos de licencias, registro y autorizaciones
Reducción del número y alcance de los requisitos obligatorios
Supervisión regulatoria en el contexto de la aprobación acelerada de medicamentos y la rápida transferencia de tecnología: garantía del cumplimiento de GMP manteniendo el acceso oportuno de los pacientes a los medicamentos
Optimización de las actividades de control y supervisión
Creación de condiciones favorables para el desarrollo empresarial
Interacción entre el sector empresarial y el gobierno en el desarrollo y aplicación de las normas de licencias de importación: diálogo y colaboración
Análisis comparativo de los sistemas de licencias de importación en diferentes países: lecciones para la mejora de la legislación nacional
El paradigma de la "Regulación Inteligente": principios, instrumentos y reducción de la carga administrativa
Del cumplimiento a la simplificación de formalidades: nuevos enfoques en la interacción entre el sector empresarial y el regulador
Exposición
Reuniones G2G, B2G y B2B
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Speakers
Director, Bob Tribe Consulting
Professional Background:
Over 40 years of experience in pharmaceutical regulatory affairs.
23 years as Head of GMP at the TGA Australia.
Former Chairman of PIC/S.
Global GMP Consultant assisting regulatory authorities worldwide in achieving PIC/S membership.
Key Achievements:
Assisted 15 GMP regulatory authorities obtain PIC/S membership over the past 18 years (the most recent was JFDA, Jordan which became a PIC/S member on 1 January 2026).
Currently assisting 6 GMP regulatory authorities prepare for either pre-accession or full accession to PIC/S.
Awards & Recognition:
US FDA Commissioner's Award (initiated ICH Q7A).
John Martin Memorial Award (RACI, Australia).
ISPE Joe Phillips Award for professional achievement.
Professional Background:
Over 40 years of experience in pharmaceutical regulatory affairs.
23 years as Head of GMP at the TGA Australia.
Former Chairman of PIC/S.
Global GMP Consultant assisting regulatory authorities worldwide in achieving PIC/S membership.
Key Achievements:
Assisted 15 GMP regulatory authorities obtain PIC/S membership over the past 18 years (the most recent was JFDA, Jordan which became a PIC/S member on 1 January 2026).
Currently assisting 6 GMP regulatory authorities prepare for either pre-accession or full accession to PIC/S.
Awards & Recognition:
US FDA Commissioner's Award (initiated ICH Q7A).
John Martin Memorial Award (RACI, Australia).
ISPE Joe Phillips Award for professional achievement.
Bob Tribe
Chairperson, Indonesian Food and Drug Authority
Professional Background:
Dr. Taruna Ikrar, M.D., M.Biomed, Ph.D. is an Indonesian pharmacologist, cardiovascular scientist, and neuroscience expert. Since 19 August 2024, he serves as Chairperson of the Indonesian Food and Drug Authority (BPOM).
Education: Hasanuddin University (1997), University of Indonesia (2003), Ph.D. in Pharmacology and Cardiology from Niigata University, Japan (2008). Postdoctoral fellowship at UC Irvine (2008–2013); Research Scholar at Harvard University (2014).
Key Achievements & Experience:
Professor at the Republic of Indonesia Defense University (2023), Prima Indonesia University (2024), and University of Technology Malaysia (2026). Visiting professor at Harvard University (2024–2026) and Tsinghua University (2025). Member of the Advisory Board of IAMRA (2025–2029); Chairman of the Indonesian Medical Council (2020–2024). Advisor at THIAMS (2019–2024) and RSPAD (2017–2024). Author of over 100 scientific publications, including in Nature. Cited more than 2,500 times; h-index 19, i10-index 27 (Google Scholar); over 2,000 citations in Scopus.
Awards: Outstanding Scientist from the US Government (2014) and UKP-Presidential Award (2017).
Professional Background:
Dr. Taruna Ikrar, M.D., M.Biomed, Ph.D. is an Indonesian pharmacologist, cardiovascular scientist, and neuroscience expert. Since 19 August 2024, he serves as Chairperson of the Indonesian Food and Drug Authority (BPOM).
Education: Hasanuddin University (1997), University of Indonesia (2003), Ph.D. in Pharmacology and Cardiology from Niigata University, Japan (2008). Postdoctoral fellowship at UC Irvine (2008–2013); Research Scholar at Harvard University (2014).
Key Achievements & Experience:
Professor at the Republic of Indonesia Defense University (2023), Prima Indonesia University (2024), and University of Technology Malaysia (2026). Visiting professor at Harvard University (2024–2026) and Tsinghua University (2025). Member of the Advisory Board of IAMRA (2025–2029); Chairman of the Indonesian Medical Council (2020–2024). Advisor at THIAMS (2019–2024) and RSPAD (2017–2024). Author of over 100 scientific publications, including in Nature. Cited more than 2,500 times; h-index 19, i10-index 27 (Google Scholar); over 2,000 citations in Scopus.
Awards: Outstanding Scientist from the US Government (2014) and UKP-Presidential Award (2017).
Dr. Taruna Ikrar
Member of the Board (Minister) for Technical Regulation of the Eurasian Economic Commission, Doctor of Biological Sciences, Professor.
Professional Background:
Alexandr Subbotin is a government official with extensive experience in management, science, education, and international cooperation. He possesses expertise in technical regulation, food security, and the development of the agro-industrial complex. He graduated from the Vitebsk State Academy of Veterinary Medicine (1998) with a degree in Veterinary Medicine and the International Institute of Management (2000) with a degree in International Economic Relations.
Key Achievements & Experience:
In 1998–2015, he worked at the Vitebsk State Academy of Veterinary Medicine, serving as Vice-Rector for Research in 2010–2012 and First Vice-Rector in 2012–2014. From 2014 to 2015, he worked as Deputy Head of the Main Economic Department of the Presidential Administration of the Republic of Belarus. In 2015, he was appointed Deputy Minister of Agriculture and Food of the Republic of Belarus — Director of the Department of Veterinary and Food Supervision of the Republic of Belarus. In 2017–2018, he was Assistant to the President of the Republic of Belarus — Inspector for the Vitebsk region.
In 2018–2020, he was Minister for Industry and Agro-Industrial Complex of the Eurasian Economic Commission.
From March to June 2020, he was Assistant to the President of the Republic of Belarus for the Mogilev region. In 2020–2021, he was Deputy Prime Minister of the Republic of Belarus. From 2021 to 2026, he headed the Vitebsk Regional Executive Committee.
By decision of the Supreme Eurasian Economic Council, from March 19, 2026, he was appointed Minister for Technical Regulation of the Eurasian Economic Commission.
Professional Background:
Alexandr Subbotin is a government official with extensive experience in management, science, education, and international cooperation. He possesses expertise in technical regulation, food security, and the development of the agro-industrial complex. He graduated from the Vitebsk State Academy of Veterinary Medicine (1998) with a degree in Veterinary Medicine and the International Institute of Management (2000) with a degree in International Economic Relations.
Key Achievements & Experience:
In 1998–2015, he worked at the Vitebsk State Academy of Veterinary Medicine, serving as Vice-Rector for Research in 2010–2012 and First Vice-Rector in 2012–2014. From 2014 to 2015, he worked as Deputy Head of the Main Economic Department of the Presidential Administration of the Republic of Belarus. In 2015, he was appointed Deputy Minister of Agriculture and Food of the Republic of Belarus — Director of the Department of Veterinary and Food Supervision of the Republic of Belarus. In 2017–2018, he was Assistant to the President of the Republic of Belarus — Inspector for the Vitebsk region.
In 2018–2020, he was Minister for Industry and Agro-Industrial Complex of the Eurasian Economic Commission.
From March to June 2020, he was Assistant to the President of the Republic of Belarus for the Mogilev region. In 2020–2021, he was Deputy Prime Minister of the Republic of Belarus. From 2021 to 2026, he headed the Vitebsk Regional Executive Committee.
By decision of the Supreme Eurasian Economic Council, from March 19, 2026, he was appointed Minister for Technical Regulation of the Eurasian Economic Commission.
Alexandr Subbotin
Senior Vice President, Strategic Compliance Consulting, Parexel
Professional Background:
Mark Birse has over 30 years of pharmaceutical industry experience, including 17 years at the UK Regulator (MHRA) and 25 years of performing both GMP/GDP audits and regulatory inspections of human and veterinary medicines.
He is a former Head of the MHRA GXP Inspectorate and Deputy Director, Inspection, Enforcement and Standards
Key Achievements & Experience:
Mark led the creation of the risk-based inspection and compliance management principles at MHRA and PIC/S GMP Reliance Procedure.
He also headed up MHRA Digital Health team 2018-2019, including x-Government AI meetings.
He is a former PIC/S Executive Bureau member and PIC/S lead assessor (assessing various agencies including FDA and ANVISA).
He has had a Qualified Person eligibility since 2003 and IRCA Principal Auditor PQMS - GMP Scheme.
Professional Background:
Mark Birse has over 30 years of pharmaceutical industry experience, including 17 years at the UK Regulator (MHRA) and 25 years of performing both GMP/GDP audits and regulatory inspections of human and veterinary medicines.
He is a former Head of the MHRA GXP Inspectorate and Deputy Director, Inspection, Enforcement and Standards
Key Achievements & Experience:
Mark led the creation of the risk-based inspection and compliance management principles at MHRA and PIC/S GMP Reliance Procedure.
He also headed up MHRA Digital Health team 2018-2019, including x-Government AI meetings.
He is a former PIC/S Executive Bureau member and PIC/S lead assessor (assessing various agencies including FDA and ANVISA).
He has had a Qualified Person eligibility since 2003 and IRCA Principal Auditor PQMS - GMP Scheme.
Mark Birse
Senior Consultant to Regulatory Authorities (GMDP Inspectorates)
Professional Background:
About 40 years' experience in EOF (Medicines Agency of Greece), 5 years' in the Pharmaceutical Industry (Roche, Switzerland). Since 2018, a self-employed International Consultant to Regulatory Agencies to achieve PIC/S membership and WHO GBT ML3 to 4. Pharmaceutical Regulatory Expert with 37 years of experience, 12 of them as Head of GMDP at EOF, the Medicines Authority of Greece. Participated for more than 25 years in EU meetings in Brussels and EMA, involved in many EU Regulations preparation. Leadership in the implementation of a Quality System according to EU, PIC/S and ISO17020 in the Greek GMDP Inspectorate and the accession of EOF to PIC/S in 2002. Represented EOF/Greece and has been a member of the PIC/S Executive Bureau (Chair of Compliance Group, monitoring new applications at PIC/S). Involvement in several State Inspectorates' PIC/S and EU assessment Teams (US FDA, Romania, Austria, Cyprus, Iran, Uganda, Armenia, UNICEF) and at the EU-Japan MRA.
Performed GMP inspections with EDQM and WHO Prequalification Program in India and China and in missions as "Assistance to CFDA" project by WHO/Global Fund. Worked for the Industry at Roche, Switzerland in External Relations Europe.
Key Achievements & Experience:
Global GMP Consultant assisting regulatory authorities in obtaining PIC/S membership, including Armenia (2012), Turkey (2013), Jordan (2020-2025), China (2019, 2024), UAE (2026). Consultant for the successful assessment by WHO GBT on all functions of a regulatory authority.
Professional Background:
About 40 years' experience in EOF (Medicines Agency of Greece), 5 years' in the Pharmaceutical Industry (Roche, Switzerland). Since 2018, a self-employed International Consultant to Regulatory Agencies to achieve PIC/S membership and WHO GBT ML3 to 4. Pharmaceutical Regulatory Expert with 37 years of experience, 12 of them as Head of GMDP at EOF, the Medicines Authority of Greece. Participated for more than 25 years in EU meetings in Brussels and EMA, involved in many EU Regulations preparation. Leadership in the implementation of a Quality System according to EU, PIC/S and ISO17020 in the Greek GMDP Inspectorate and the accession of EOF to PIC/S in 2002. Represented EOF/Greece and has been a member of the PIC/S Executive Bureau (Chair of Compliance Group, monitoring new applications at PIC/S). Involvement in several State Inspectorates' PIC/S and EU assessment Teams (US FDA, Romania, Austria, Cyprus, Iran, Uganda, Armenia, UNICEF) and at the EU-Japan MRA.
Performed GMP inspections with EDQM and WHO Prequalification Program in India and China and in missions as "Assistance to CFDA" project by WHO/Global Fund. Worked for the Industry at Roche, Switzerland in External Relations Europe.
Key Achievements & Experience:
Global GMP Consultant assisting regulatory authorities in obtaining PIC/S membership, including Armenia (2012), Turkey (2013), Jordan (2020-2025), China (2019, 2024), UAE (2026). Consultant for the successful assessment by WHO GBT on all functions of a regulatory authority.
Dr. Vee (Vasiliki) Revithi
Founder & Managing Director, CONSILIUM LPG Consulting Services S.M.P.C.Chemist, TQM MBA. Senior Pharmaceutical Regulatory Expert.
Professional Background:
2022 – Present: Founder & Managing Director, CONSILIUM LPG Consulting Services S.M.P.C., Greece.Consulting services on GMP/GDP compliance, regulatory systems strengthening, quality management systems, and market surveillance of pharmaceutical enterprises.
International Consultant for pharmaceutical regulatory systems:
Jordan (JFDA / IFC – World Bank Group): PIC/S accession preparation, WHO GBT alignment, QMS development, SOPs, and inspector training.
Pakistan (DRAP / WHO): Strengthening market surveillance and control systems for substandard and falsified medical products.
UAE (Dubai Regulatory Authority): GMP/GDP compliance, inspection systems, and QMS strengthening.
2014 – 2021: Head of Production & Distribution Control Division (GMP/GDP Inspectorate), EOF Greece.
2011 – 2013: Head of Market Surveillance Section, EOF Greece.
Key Achievements & Experience:
More than 20 years of experience in GMP/GDP inspections, market surveillance, and pharmaceutical regulatory systems strengthening.
Successfully supported PIC/S accession and ISO/IEC 17020 accreditation of the EOF GMP/GDP Inspectorate.
Contributed to the EU–US FDA Mutual Recognition Assessment, confirming the equivalence of the Greek GMP inspection system.
Extensive experience supporting WHO, PIC/S, and EU regulatory alignment in Europe and the Middle East.
Expert in quality management systems (ISO 9001, ISO 17020, ISO 13485), risk-based post-marketing surveillance, and supply chain integrity.
Certified Trainer for Adults and External Assessor for Medical Devices Accreditation.
Official representative of the Greek Ministry of Health and EOF in several European and international regulatory bodies.
Professional Background:
2022 – Present: Founder & Managing Director, CONSILIUM LPG Consulting Services S.M.P.C., Greece.Consulting services on GMP/GDP compliance, regulatory systems strengthening, quality management systems, and market surveillance of pharmaceutical enterprises.
International Consultant for pharmaceutical regulatory systems:
Jordan (JFDA / IFC – World Bank Group): PIC/S accession preparation, WHO GBT alignment, QMS development, SOPs, and inspector training.
Pakistan (DRAP / WHO): Strengthening market surveillance and control systems for substandard and falsified medical products.
UAE (Dubai Regulatory Authority): GMP/GDP compliance, inspection systems, and QMS strengthening.
2014 – 2021: Head of Production & Distribution Control Division (GMP/GDP Inspectorate), EOF Greece.
2011 – 2013: Head of Market Surveillance Section, EOF Greece.
Key Achievements & Experience:
More than 20 years of experience in GMP/GDP inspections, market surveillance, and pharmaceutical regulatory systems strengthening.
Successfully supported PIC/S accession and ISO/IEC 17020 accreditation of the EOF GMP/GDP Inspectorate.
Contributed to the EU–US FDA Mutual Recognition Assessment, confirming the equivalence of the Greek GMP inspection system.
Extensive experience supporting WHO, PIC/S, and EU regulatory alignment in Europe and the Middle East.
Expert in quality management systems (ISO 9001, ISO 17020, ISO 13485), risk-based post-marketing surveillance, and supply chain integrity.
Certified Trainer for Adults and External Assessor for Medical Devices Accreditation.
Official representative of the Greek Ministry of Health and EOF in several European and international regulatory bodies.
Ms. Pantelia GKOURA
GMP Expert, Inspector with South African Health Products Regulatory Authority (SAHPRA)
Professional Background:
GMP Expert.
Inspector with South African Health Products Regulatory Authority (SAHPRA) responsible for conducting national and international inspections.
Chair of the GMP Technical Committee of African Medicines Regulatory Harmonization (AMRH).
Chair of the GMP Technical Committee focusing on Vaccine, Biological and API manufacture under the auspices of the African Medicines Regulatory Harmonization, which is transitioning to the African Medicines Agency.
Member of ZAZIBONA Inspection Team.
Member of WHO PQ inspection team.
Member of WHO RSS team.
Member of various workgroups e.g. Annex 1 Implementation team, Unique Facility Identifiers, Contamination and Cross Contamination in Shared facilities, Anti-Microbial Resistance and Waste Treatment.
Professional Background:
GMP Expert.
Inspector with South African Health Products Regulatory Authority (SAHPRA) responsible for conducting national and international inspections.
Chair of the GMP Technical Committee of African Medicines Regulatory Harmonization (AMRH).
Chair of the GMP Technical Committee focusing on Vaccine, Biological and API manufacture under the auspices of the African Medicines Regulatory Harmonization, which is transitioning to the African Medicines Agency.
Member of ZAZIBONA Inspection Team.
Member of WHO PQ inspection team.
Member of WHO RSS team.
Member of various workgroups e.g. Annex 1 Implementation team, Unique Facility Identifiers, Contamination and Cross Contamination in Shared facilities, Anti-Microbial Resistance and Waste Treatment.
Mr. Wayne Matheuw Müller
Global Process Science & Regulator Director, Fedegari. Member of the International Board of Directors, International Society of Pharmaceutical Engineering, ISPE
Professional Background:
In her current role at Fedegari, Ms. Shanshan is leading the advancement of manufacturing systems for emerging modalities and engagement with global regulators. She brings over 20 years of international experience across pharma manufacturing and consulting organisations, with expertise spanning process science, engineering, quality, compliance, and regulatory.
Shanshan is an ISPE International Board member and certified trainer, committed to advancing collaboration and knowledge sharing across the life sciences industry.
Professional Background:
In her current role at Fedegari, Ms. Shanshan is leading the advancement of manufacturing systems for emerging modalities and engagement with global regulators. She brings over 20 years of international experience across pharma manufacturing and consulting organisations, with expertise spanning process science, engineering, quality, compliance, and regulatory.
Shanshan is an ISPE International Board member and certified trainer, committed to advancing collaboration and knowledge sharing across the life sciences industry.
Shanshan Liu
Manager of Biological Inspection Administration at Egyptian Drug Authority (EDA). Chair. of GMP subcommittee of vaccine at African Medicine Agency.
Professional Background:
Over 16 years of experience in pharmaceutical regulation and GMP inspections, with extensive expertise in biological products, vaccines, blood products, biosimilars, and plasma-related facilities.
Currently serving as Manager of the Biological Inspection Administration at the Egyptian Drug Authority since 2024.
Previously held several regulatory and leadership positions within EDA, including Chairman of the Technical Office (2022−2024).
Active contributor to WHO regulatory initiatives and African Medicines Regulatory Harmonization (AMRH) activities, including inspector training, quality systems development, and risk-based inspection programs.
Key Achievements & Experience:
Played a significant role in strengthening pharmaceutical regulatory systems at both national and international levels.
Contributed to the development and revision of regulations and guidelines related to radiopharmaceuticals, plasma apheresis centers, biosimilars, vaccines, and blood products in Egypt.
Internationally, collaborates with WHO and AMRH initiatives as a WHO GMP Advisor and focal point for biological inspections during WHO accreditation activities.
Serves as Chairperson of the Vaccine GMP Sub-Technical Committee at AMRH (AMA), leading initiatives for guideline harmonization, inspection capacity building, and regulatory strengthening across African countries.
Professional Background:
Over 16 years of experience in pharmaceutical regulation and GMP inspections, with extensive expertise in biological products, vaccines, blood products, biosimilars, and plasma-related facilities.
Currently serving as Manager of the Biological Inspection Administration at the Egyptian Drug Authority since 2024.
Previously held several regulatory and leadership positions within EDA, including Chairman of the Technical Office (2022−2024).
Active contributor to WHO regulatory initiatives and African Medicines Regulatory Harmonization (AMRH) activities, including inspector training, quality systems development, and risk-based inspection programs.
Key Achievements & Experience:
Played a significant role in strengthening pharmaceutical regulatory systems at both national and international levels.
Contributed to the development and revision of regulations and guidelines related to radiopharmaceuticals, plasma apheresis centers, biosimilars, vaccines, and blood products in Egypt.
Internationally, collaborates with WHO and AMRH initiatives as a WHO GMP Advisor and focal point for biological inspections during WHO accreditation activities.
Serves as Chairperson of the Vaccine GMP Sub-Technical Committee at AMRH (AMA), leading initiatives for guideline harmonization, inspection capacity building, and regulatory strengthening across African countries.
Dr. Heba Bahaa
Senior GMP Inspector/ Lead Inspector, South African Health Products Regulatory Authority (SAHPRA)
Professional Background:
Ms Mankeke F. Tlhoaele is an accomplished Senior GMP and Lead Inspector at the South African Health Products Regulatory Authority (SAHPRA), bringing 15 years of deep expertise in GxP regulatory oversight.
Throughout her career, she has led over 100 domestic and international inspections, covering a vast spectrum of complex manufacturing environments. Her technical expertise spans sterile and non-sterile facilities, including high-potency substances (hormones, cytotoxins), biomanufacturing (vaccines), radiopharmaceuticals, medicinal gases, and cannabis.
Key Achievements & Experience:
Beyond her national responsibilities, Ms. Tlhoaele has established herself as a prominent figure in international regulatory harmonization. She is appointed by the African Medicines Regulatory Harmonization (AMRH) as a GMP Inspector to participate in the Pilot of the Continental Listing of Medicinal Products. S
She is also an active member of the Southern African Development Community (SADC) GMP Quality Circle, contributing to regional quality assurance and regulatory collaboration.
Her leadership extends to the ZAZIBONA Initiative, where she serves as a Lead Inspector in collaborative medicines registration inspections across SADC member states. In addition, she has supported global quality standards through her role as a Seasonal GMP Inspector with the World Health Organization (WHO) Prequalification Inspection Service contributing to the assurance of safe, effective, and high-quality medicines worldwide.
Professional Background:
Ms Mankeke F. Tlhoaele is an accomplished Senior GMP and Lead Inspector at the South African Health Products Regulatory Authority (SAHPRA), bringing 15 years of deep expertise in GxP regulatory oversight.
Throughout her career, she has led over 100 domestic and international inspections, covering a vast spectrum of complex manufacturing environments. Her technical expertise spans sterile and non-sterile facilities, including high-potency substances (hormones, cytotoxins), biomanufacturing (vaccines), radiopharmaceuticals, medicinal gases, and cannabis.
Key Achievements & Experience:
Beyond her national responsibilities, Ms. Tlhoaele has established herself as a prominent figure in international regulatory harmonization. She is appointed by the African Medicines Regulatory Harmonization (AMRH) as a GMP Inspector to participate in the Pilot of the Continental Listing of Medicinal Products. S
She is also an active member of the Southern African Development Community (SADC) GMP Quality Circle, contributing to regional quality assurance and regulatory collaboration.
Her leadership extends to the ZAZIBONA Initiative, where she serves as a Lead Inspector in collaborative medicines registration inspections across SADC member states. In addition, she has supported global quality standards through her role as a Seasonal GMP Inspector with the World Health Organization (WHO) Prequalification Inspection Service contributing to the assurance of safe, effective, and high-quality medicines worldwide.
Mankeke F Tlhoaele
Technical Officer (GxP Inspector), World Health Organisation (WHO)
Professional Background:
Since 2010 Vimal Sachdeva is working with the WHO Prequalification Unit as a Senior GxP Inspector, with extensive experience in pharmaceutical quality and regulatory compliance. He has conducted more than 300 on-site GxP inspections worldwide, covering GMP and other GxP areas across diverse pharmaceutical manufacturing and quality systems.
Prior to joining WHO in Geneva, Switzerland, he worked with Singapore’s Health Sciences Authority (HSA), the national regulatory authority, as a Senior GMP Auditor and Regulatory Consultant.
His professional experience spans international GMP inspections, pharmaceutical quality systems, regulatory compliance, manufacturing operations, quality control, investigations, and assessment of complex GxP risks.
Professional Background:
Since 2010 Vimal Sachdeva is working with the WHO Prequalification Unit as a Senior GxP Inspector, with extensive experience in pharmaceutical quality and regulatory compliance. He has conducted more than 300 on-site GxP inspections worldwide, covering GMP and other GxP areas across diverse pharmaceutical manufacturing and quality systems.
Prior to joining WHO in Geneva, Switzerland, he worked with Singapore’s Health Sciences Authority (HSA), the national regulatory authority, as a Senior GMP Auditor and Regulatory Consultant.
His professional experience spans international GMP inspections, pharmaceutical quality systems, regulatory compliance, manufacturing operations, quality control, investigations, and assessment of complex GxP risks.
Vimal Sachdeva
Senior Regulatory Affairs Associate, Roche Holding AG
Professional Background:
A highly accomplished regulatory scientist with a decade of specialized experience in the evaluation, policy formulation, and registration of Biological Medicines. Founder and inaugural Chairperson of the African Blood Regulatory Forum (ABRF-TC) — a premier Continental Technical Working Group under the African Medicines Regulatory Harmonisation (AMRH) initiative. Spearheaded the historic unification of blood and blood product regulations across South Africa and the wider African continent.
This leadership has been pivotal in advising the African Medicines Agency (AMA) and AUDA-NEPAD, driving the creation of harmonized technical guidelines, innovative regulatory pathways, and reliance frameworks across Member States. A trusted voice on expert committees, bridging complex biological assessment with continental healthcare strategy to ensure equitable access to quality-assured, safe, and affordable blood products for all African citizens. Over the past 17 years, significant contributions have been made to the advancement of global health regulation through peer-reviewed publications and high-level international representation.
Key Publications & Research:
Published definitive frameworks on biosimilar registration and blood product implementation in the GaBI Journal and Research Square.
Authored a landmark 10-country sub-Saharan haemovigilance study.
Presentations & Speaking Engagements:
Featured speaker at the WHO's 18th International Conference of Drug Regulatory Authorities (ICDRA) in Dublin. Featured speaker at the 1st International Symposium on Streptococcus agalactiae Disease in Cape Town.
Professional Background:
A highly accomplished regulatory scientist with a decade of specialized experience in the evaluation, policy formulation, and registration of Biological Medicines. Founder and inaugural Chairperson of the African Blood Regulatory Forum (ABRF-TC) — a premier Continental Technical Working Group under the African Medicines Regulatory Harmonisation (AMRH) initiative. Spearheaded the historic unification of blood and blood product regulations across South Africa and the wider African continent.
This leadership has been pivotal in advising the African Medicines Agency (AMA) and AUDA-NEPAD, driving the creation of harmonized technical guidelines, innovative regulatory pathways, and reliance frameworks across Member States. A trusted voice on expert committees, bridging complex biological assessment with continental healthcare strategy to ensure equitable access to quality-assured, safe, and affordable blood products for all African citizens. Over the past 17 years, significant contributions have been made to the advancement of global health regulation through peer-reviewed publications and high-level international representation.
Key Publications & Research:
Published definitive frameworks on biosimilar registration and blood product implementation in the GaBI Journal and Research Square.
Authored a landmark 10-country sub-Saharan haemovigilance study.
Presentations & Speaking Engagements:
Featured speaker at the WHO's 18th International Conference of Drug Regulatory Authorities (ICDRA) in Dublin. Featured speaker at the 1st International Symposium on Streptococcus agalactiae Disease in Cape Town.
Khamusi Philip Mutoti
Head of Inspection and Licensing Department, Macedonian Agency for medicines and medical devices
Professional Background:
Ms. Doncheva is a Graduate Pharmacist, Specialist in Pharmaceutical Technology.
She has more than 25 years of experience in pharmaceutical inspection. Performed more than 80 GMP inspections in Macedonia and abroad as senior GMP inspector
Key Achievements & Experience:
Professional Background:
Ms. Doncheva is a Graduate Pharmacist, Specialist in Pharmaceutical Technology.
She has more than 25 years of experience in pharmaceutical inspection. Performed more than 80 GMP inspections in Macedonia and abroad as senior GMP inspector
Key Achievements & Experience:
- Member of the GMDP Inspectors Working Group in the European Medicines Agency (EMA), as observer, for over 15 years
- Delegate at the Committee of Experts on Minimizing the Public Health Risks Posed by Falsification of Medical Products and Similar Crimes at the European Directorate for Quality of Medicines (EDQM)
- Participates in working groups for drafting laws and legal regulations in the health care and pharmacy
Mirjana Doncheva
Head of Cell therapy localisation strategy, Alexion (AstraZeneca group)
Professional Background:
Received the Dr. med. degree from the University of Basel for research in cell technologies, has 10 years of experience in ATMP development and GMP manufacturing, including leading the establishment and regulatory licensing of CAR-T manufacturing operations, currently leads cell-therapy localization strategy at Alexion (AstraZeneca group). Participant of an expert panels on ATMP quality and GMP compliance.
Professional experience includes overseeing the manufacture of a clinical CAR-T batches at the first in Russia licensed manufacturing site and developing a manufacturing model with an aggregate capacity of up to 160 patient-specific batches per year.
Professional Background:
Received the Dr. med. degree from the University of Basel for research in cell technologies, has 10 years of experience in ATMP development and GMP manufacturing, including leading the establishment and regulatory licensing of CAR-T manufacturing operations, currently leads cell-therapy localization strategy at Alexion (AstraZeneca group). Participant of an expert panels on ATMP quality and GMP compliance.
Professional experience includes overseeing the manufacture of a clinical CAR-T batches at the first in Russia licensed manufacturing site and developing a manufacturing model with an aggregate capacity of up to 160 patient-specific batches per year.
Denis Baranovskii
Senior Principal Assistant Director Good Manufacturing Practice Section, Centre for Compliance and Quality Control. National Pharmaceutical Regulatory Agency (NPRA), Malaysia
Professional Background:
Regulatory pharmacist and GMP Inspector with more than 15 years of experience in regulatory and enforcement pharmaceutical services. Holds a Bachelor of Pharmacy (Hons), Master of Enforcement Law and Master of Business Administration (MBA).
Currently heads the Quality Management and Organization Unit within the GMP Section, NPRA. Regulatory expertise covers Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Active Pharmaceutical Ingredients (APIs) and Good Preparation Practice (GPP).
Key Achievements & Experience:
Experience in GMP and GDP inspections, with involvement in more than 300 inspections of pharmaceutical premises in Malaysia and overseas, covering finished pharmaceutical products and APIs.
Member of national working groups involved in the various development and revision of regulatory guidelines for GMP, GDP and GPP.
Currently involved in the development of a new national regulatory framework and supporting legislation for APIs in Malaysia. Speaker at various regulatory seminars, training programmes and conferences.
Professional Background:
Regulatory pharmacist and GMP Inspector with more than 15 years of experience in regulatory and enforcement pharmaceutical services. Holds a Bachelor of Pharmacy (Hons), Master of Enforcement Law and Master of Business Administration (MBA).
Currently heads the Quality Management and Organization Unit within the GMP Section, NPRA. Regulatory expertise covers Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Active Pharmaceutical Ingredients (APIs) and Good Preparation Practice (GPP).
Key Achievements & Experience:
Experience in GMP and GDP inspections, with involvement in more than 300 inspections of pharmaceutical premises in Malaysia and overseas, covering finished pharmaceutical products and APIs.
Member of national working groups involved in the various development and revision of regulatory guidelines for GMP, GDP and GPP.
Currently involved in the development of a new national regulatory framework and supporting legislation for APIs in Malaysia. Speaker at various regulatory seminars, training programmes and conferences.
ABDUL HAKIM bin Mohd Isa
Director of Quality Control and Assurance, LLC "Medicine and nuclear technologies"
Professional Background:
18 years of experience in pharmaceutical manufacturing, including 16 years in the production of sterile radiopharmaceuticals. Worked at five different manufacturing sites.
Mr. Semenov was responsible for obtaining GMP certification for four sites; at three of these, manufacturing processes were established from scratch. Registered two radiopharmaceuticals with the Ministry of Health of the Russian Federation (obtained marketing authorizations).
Professional Background:
18 years of experience in pharmaceutical manufacturing, including 16 years in the production of sterile radiopharmaceuticals. Worked at five different manufacturing sites.
Mr. Semenov was responsible for obtaining GMP certification for four sites; at three of these, manufacturing processes were established from scratch. Registered two radiopharmaceuticals with the Ministry of Health of the Russian Federation (obtained marketing authorizations).
Nikolai Semenov
Acting Director of the Directorate for the Control of Drug, Narcotic, Psychotropic, and Precursor Production. Indonesian Food and Drug Authority (Badan POM)
Professional Background:
With over 15 years of experience as a GMP inspector, she has led and participated in numerous international inspections in China, India, South Korea, Japan, and Puerto Rico.
Her expertise covers regulatory systems strengthening, quality management systems, and oversight of biological products and advanced therapy medicinal products (ATMPs). She serves as a PIC/S assessor and actively contributes to global regulatory convergence initiatives, including participation in international regulatory assessments and expert circles on ATMPs.
She holds a PhD from Monash University, with research focusing on stem cell biology and regenerative medicine, and actively supports national and regional capacity building in regulatory science.
Professional Background:
With over 15 years of experience as a GMP inspector, she has led and participated in numerous international inspections in China, India, South Korea, Japan, and Puerto Rico.
Her expertise covers regulatory systems strengthening, quality management systems, and oversight of biological products and advanced therapy medicinal products (ATMPs). She serves as a PIC/S assessor and actively contributes to global regulatory convergence initiatives, including participation in international regulatory assessments and expert circles on ATMPs.
She holds a PhD from Monash University, with research focusing on stem cell biology and regenerative medicine, and actively supports national and regional capacity building in regulatory science.
Shanti Marlina Sibuea
