Invitación a participar en la organización del 3º Foro Internacional de Inspecciones Farmacéuticas (IFPI-2026)
El Comité Organizador del IFPI tiene el honor de invitarles a participar en la organización del 3º Foro Internacional de Inspecciones Farmacéuticas (IFPI-2026).
El 1º Foro Internacional de Inspecciones Farmacéuticas, celebrado en Dubái en 2024, y el 2º Foro, celebrado en Abu Dabi en 2025, demostraron la gran relevancia de este evento para la comunidad mundial de las Buenas Prácticas de Fabricación (GMP). El IFPI brinda una oportunidad única para que las autoridades reguladoras nacionales, los inspectores farmacéuticos y los expertos de la industria intercambien mejores prácticas, colaboren en el desarrollo y profundización de la cooperación y el intercambio de información regulatorios, promuevan la convergencia de los enfoques normativos y eleven los estándares globales de calidad de las inspecciones farmacéuticas. De acuerdo con la decisión adoptada por el Comité Organizador del IFPI-2025, la sede del Foro IFPI en 2026 se seleccionará en base a las propuestas de los países participantes.
La sede del evento ofrecerá al país anfitrión las siguientes ventajas:
Participación activa en la definición de la agenda del 3º Foro Internacional de Inspecciones Farmacéuticas.
Oportunidad de presentar las características y los logros del sistema de regulación farmacéutica de su país.
Posibilidad de mostrar los avances de las compañías farmacéuticas nacionales.
Fortalecimiento de su propia imagen y ampliación de oportunidades para la cooperación multilateral en materia regulatoria, así como el fomento de la colaboración internacional con la industria (B2G).
Intercambio de conocimientos y experiencias con los principales expertos internacionales en el ámbito de las inspecciones farmacéuticas.
Si están interesados en que su país sea la sede de este importante evento, les invitamos a revisar nuestros criterios de selección y completar el formulario correspondiente. Su iniciativa permitirá fortalecer los vínculos comerciales, ampliar los horizontes de cooperación y puede ser clave para una organización y realización del evento al más alto nivel.
En caso de estar interesados, se ruega enviar una carta oficial de intenciones en formato libre al Comité Organizador del Foro, manifestando la voluntad de actuar como país anfitrión, a la dirección de correo electrónico: info@ifpi-forum.com, a más tardar el 20 de enero de 2026.
Como siguiente paso, les solicitamos completar el formulario adjunto y enviarlo por correo electrónico a info@ifpi-forum.com antes del 30 de enero de 2026.
Foro Internacional de Inspecciones Farmacéuticas (IFPI)
Es la plataforma para el diálogo profesional, el intercambio de experiencias y la formación del futuro del sector farmacéutico.
El IFPI tiene por objetivo fomentar la cooperación entre los organismos reguladores de diferentes regiones del mundo en el ámbito de la regulación de la producción de medicamentos y las inspecciones GMP, especialmente en los países del Sur Global y Eurasia.
Garantía de la disponibilidad de medicamentos de calidad, seguros y eficaces mediante el desarrollo del sistema de inspección farmacéutica, la unificación normativa y el fortalecimiento de la comunidad profesional de inspectores.
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.
Khamusi Philip Mutoti
Current Position: 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.
Pantelia Gkoura
Current Position: 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.
Dr. Vee (Vasiliki) Revithi
Current Position: 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.
Liang Zhao
Current Position: Senior Vice President, BioEngine, China
Professional Background: Has dedicated 25 years to the industrialization of protein drugs and viral biologics based on cell culture technology. In particular, he accumulates extensive experience in the efficient industrial production technology of biopharmaceuticals and viral vaccines, the medium and process development and large-scale manufacturing of the key raw materials—serum-free culture media, as well as the regulation of critical quality attributes of products.
As a lead, he has presided over multiple key projects—such as the National 863 Program, NSFC grants, and Shanghai Science and Technology Commission initiatives—he successfully addressed critical scale-up and engineering challenges, accelerating the industrialization of related bioproducts.
Key Achievements & Experience: Contributed to regulatory infrastructure by serving as a principal drafter of China’s first two group quality standards for serum free media (T/SBIAORG 0002 2022 & T/SBIAORG 0003 2022), establishing the guides for cell culture medium quality
Wayne Matheuw Müller
Current Position: 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.
Dr. Heba Bahaa
Current Position: Manager of Biological Inspection Administration at Egyptian Drug Authority (EDA). Chairman 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.
Mankeke F Tlhoaele
Current Position: 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.
Las empresas farmacéuticas tienen la oportunidad de presentar sus productos en la feria que se celebra en el marco del Foro
En 2025, participaron en la feria las principales empresas farmacéuticas. Se presentaron novedades en el ámbito de los medicamentos innovadores, los biosimilares y los genéricos