Technical Director. No deviation Pte. Ltd. International Board of Directors International Society of Pharmaceutical Engineering, ISPE. Shanshan Liu is the current Technical Director at No deviation, responsible for the company’s technology and innovation roadmap. She also sits on the Core Team, defining the company’s international growth and business strategy. She received her M.Sc. in Biochemical Engineering from the University of Birmingham and brings an international perspective to her work from her experiences across various continents.
Throughout her 18-year career, Shanshan has held various technical roles within consulting firms and major pharmaceutical companies, including Novartis, where she worked within the Global Engineering organization. With a solid technical background, Shanshan expanded her expertise into the Quality, Compliance, and Regulatory domains, assisting pharmaceutical and medical device manufacturers in establishing quality systems, remediating quality and compliance risks, and forming regulatory strategies. Shanshan is passionate about connecting people and technologies in the life science industry, and is devoted to fostering international collaborations. She currently serves on the ISPE International Board, contributing to its global mission and vision. To further share her knowledge, Shanshan is qualified as an ISPE instructor for various modules, spanning GMP to ATMP.

Director of Reference National Laboratory, Drug Department, Emirates Drug Establishment. Dr. Shaikha Almazrouei is an Emirati scientist with the following education qualifications:

• PhD, King's College London (Liver transplant using hepatocyte microbes)
• MSc, King's College London (Stem cells from bench to market)
• MSc, UAEU (Genetic basis of familial hypercholesterolemia)
• Bachelor of Cellular and Molecular Biology from UAEU

Active member of international NGOs in the field of stem cells and regenerative medicine.

• Member of International Society of Cell & Gene Therapy (ISCT)
• Member of International Stem Cells Research Association (ISCCR)
• Member of UAE Scholars
• Chairman and Co-founder of UAE Stem Cell Society

Participated in many national projects such as:

• Establishing Emirate Genome Program & the Omics Center of Excellence with G42
• Establishing the Biotechnology Research Center at Abu Dhabi Technology Innovation Institute

Director of the Federal State Institution “State Institute of Drugs and Good Practices” (FSI “SID & GP”). Honorary Chemist of the Russian Federation, certified GMP inspector and auditor, he completed professional training programs on GMP inspection/audit and holds the international WHO certificate (GMP inspection, Quality Management System for national regulatory authorities). The Russian GMP Inspectorate (first in the country) was created under his leadership, where he oversaw planning, development, personnel, and compliance procedures. Since 2016, he has been Deputy Head of the Russian GMP Inspectorate and Head of the Good Practices Committee of the Council for Professional Qualifications in Pharmacy of the National Pharmaceutical Chamber. He is author/co-author of 11 patents, 61 publications, and the monographs “What is Acceptable and Unacceptable in Pharmaceutical Manufacture” and “GMP Standard. Case Studies,” serving as training guides for pharma specialists. Vladislav Shestakov initiated the annual Pan-Russian GMP Conference with International Engagement, attended by many foreign participants, which has grown into a key event addressing current industry issues. Since February 2020, he chairs the Board of Directors of the National Centre for Reference Standards, LLC, and since December 2020, he is the sole founder of the Autonomous Non-Commercial Organization “Eurasian Academy of Good Practices.” In the 2017 “Importance Rating” survey by KPMG, Battersea Power Marketing, and Pharmvestnik, he was recognized as the most influential person in GMP development in Russia and beyond.

Senior Pharmacist, QP GMP Consultant

Dr. Jean-Denis Mallet is a former pharmaceutical inspector. He possesses a diverse range of expertise in the industry (1986−1994), he worked for the French Agency for the Safety of Health Products (AFSSAPS) in 1994−1999 and then in 2003−2006. Dr. JD Mallet has been working in the International Red Cross (2007−2010). Since 2010, he has been a GMP consultant.  

Technical Assistant to the Director General, Jordan Food and Drug Administration (JFDA)
Since January 2021, holds the position of Technical Assistant to the Director General of JFDA. Previously served in several key roles within JFDA, including Director of the Drug Directorate for 4 years, and with five years of experience as Head of the Drug Registration Department. Gained two years of experience in the UAE private sector as an External Regulatory Affairs Specialist. Worked with international organizations (USAID, WHO, ICH, PIC/S, and FAO), led Jordan’s accession to the ICH, and now represents JFDA in the assembly. Team head of the PIC/S initial project. Under Dr. Wesal’s leadership, Jordan completed the pre-accession process and moved to the accession phase to become a PIC/S member.

Vice-president of commerce JSC Pharmasyntez
2018 – 2025 Executive Director of JSC Pharmasyntez

Vice President of China Association for Vaccines
Mr. Fu Bainian has served as:

• General Manager, Changchun Institute of Biological Products Co., Ltd.
• Deputy General Manager, Changchun Institute of Biological Products Co., Ltd.
• Deputy General Manager, Beijing Tiantan Biological Products Co., Ltd.
• Deputy General Manager, Lanzhou Institute of Biological Products Co., Ltd.
• General Manager, Changchun Keygen Biological Products Co., Ltd.
• General Manager, Changchun Institute of Biological Products Co., Ltd.

Mr. Fu is one of the veterans in the Chinese vaccine industry and has held several leading positions in a variety of vaccine companies, playing key roles in administration, R&D, manufacturing, marketing, and regulation.
He currently holds the position of Vice President of the China Association for Vaccines, which has more than 40 branches and over 330 member companies and organizations in the vaccine and biologicals sector in China. The Association bridges the relationship between companies and the NMPA (Chinese National Medical Products Administration) and coordinates business activities of its members.

Deputy Director of the State Institution "State Pharmaceutical Supervision in the Circulation of Medicines (Gosfarmnadzor)" of the Republic of Belarus.

Sergey Seredyuk has extensive experience in the development and evaluation of legal and regulatory acts, as well as in the analysis of law enforcement practices. He has participated in the development of over 100 draft regulatory acts in the field of medicines circulation.
Previous experience:

1. Chief Specialist of the Main Department of Mandatory Legal Expertise of Regulatory Acts, Ministry of Justice of the Republic of Belarus;
2. Senior Specialist of the Department of Mandatory Legal Expertise of Technical Regulatory Acts, National Center of Legal Information of the Republic of Belarus.

GMP Inspections Coordinator — African Medicines Regulatory Harmonisation (AMRH)
Washington Dengu is a pharmaceutical and regulatory affairs expert with 15+ years' experience across Africa. He has held senior roles at AUDA-NEPAD [AMRH], WHO [Afro C HQ], and SADC (Zazibona), and has national experience in Zimbabwe supporting Africa’s Agenda 2063. He is currently Continental GMP Coordinator at AMRH, leading the operationalization of the African Medicines Agency (AMA). He developed the continental Playbook for inspection procedures, coordinated pilot GMP inspections for biological products and vaccines, and trained over 400 regulators. In industry, he led the design, validation, and licensing of a pharmaceutical plant in Zimbabwe, commercializing 20+ products within 2 years. A recognized thought leader, he co-authored WHO guidance on antimicrobial resistance in pharmaceutical production and waste management, contributed to strengthening regulatory systems, achieving WHO Maturity Level 3 for Zimbabwe, and promoting local production through guidance for greenfield and existing facilities. As a PhD candidate in Strategic Management, Washington combines practical experience with academic insight, advancing regulatory harmonization, GMP, and capacity building to support Africa’s health security.

New Products and R&D Director. Member of the Board of Directors Promomed Group. 20xx-20xx: National medical manager Promomed 20xx-20xx: R&D Director Promomed

• 20xx-currently: New Products and R&D Director. Author of over 40 scientific articles (Hirsch index 8) 
• Owner of 15 patents
• National&International Speaker of Industrial Events (+xx congresses…)
• Led more than 70 clinical trials and new developments (next in class& original drugs) resulting registration of more than 80 new drugs over the past 3 years. 

Recent: The first Russian semaglutide (Welgia, Quinsenta) and tirzepatide (Tirzetta) for the treatment of obesity and diabetes in Russia. All manufactured using own patented full-cycle technologies.

Deputy Head of International Cooperation, Division of FSI "SID&GP". Deputy Head of the Department for Inspection of Foreign Manufacturers of Medicines, FSI "SID&GP". Deputy Head of Division of Foreign Medicines Manufacturers Inspection. Firn M LLC, Head of QC Division. As a GMP inspector, participated in more than 200 international GMP inspections.

Chairperson National Drug Authority (Uganda). Chairperson NDA board since 2017.

Dr. Medard Bitekyerezo is a highly respected medical doctor and specialist physician, academic, legislator, and public health regulator. As a former Lecturer of Internal Medicine at Mbarara University of Science and Technology and a member of the 9th Parliament of Uganda, he chaired the Committee on Health and champions regulatory excellence, institutional integrity, and stakeholder collaboration. He is a member of the Uganda National Medical Stores (NMS) Board, the Chairperson of the Country Coordinating Mechanism for the Global Fund in Uganda, and the current Chairperson of the Uganda National Drug Authority. His leadership continues to shape the NDA’s trajectory toward global best standards and improved public health outcomes for Ugandans. 

Director of Quality Assurance — Sterility Assurance MSD Pharmaceuticals.

Will Peterson, Director of sterility assurance at MSD, has spent his 15-year career focused on sterilizing filtration, sterility assurance, and single-use technology. Sitting in a global quality department, he supports dozens of internal & external manufacturing sites with respect to selection, validation, and troubleshooting of these technologies. He has establishing himself as a technical expert on the topics within MSD and the industry, co-leading of the PDA Filtration Interest Group, lead author on PDA Technical Report #26 Revision committee and serving as a founding member of the biophorum Sterile Filtration Quality Risk Management team and Closed system Integrity Assurance team.

Director Advisor, Center for State Control of Medicnes and Medical Devices (CECMED), Cuba. Over the past decade, Ms. Pérez Ojeda has led international cooperation initiatives at the CECMED, Cuba’s National Regulatory Authority. She served as Founder and Head of the International Affairs Office (2006−2020) and currently advises on strategic regulatory cooperation and policy development. Her work focuses on strengthening regulatory reliance, promoting trust among National Regulatory Authorities (NRAs), and advancing the implementation of Good Regulatory Practices (GRP). Ms. Pérez Ojeda holds a Bachelor’s degree in Pharmaceutical Sciences and a Master’s in Clinical Pharmacy from the University of Havana, as well as postgraduate training in International Public Health and Science Diplomacy. With 30 years in the health sector and 24 in medicines regulation, she has played a key role in fostering regulatory cooperation, evaluation of authorities, and innovation policies linking intellectual property and access to medicines. She represented Cuba in the negotiations of the WHO Global Strategy on Innovation, Access, and Intellectual Property and has completed over 40 specialized courses offered by WHO, PAHO, and WTO. She has published more than 15 scientific papers and continues to advocate for regulatory convergence and mutual trust among agencies to strengthen public health systems globally.

Chief Medical Officer, R-Pharm. Dr. Mikhail Samsonov is an active speaker and panel expert at various international conferences on clinical operations and developmental strategies for emerging markets. Dr. Samsonov’s education includes: MD from Moscow Medical University, National Cardiology Centre (Moscow) training in Clinical Cardiology, a Ph.D. in Cardiology & Immunology from the National Cardiology Center, a BA from Open University, London, and several business courses at INSEAD and OWEN business schools. Previous work experience: Graduated from the Pirogov Russian National Research Medical University, studied at the National Heart Center in Moscow and the Open University in London. Holds PhD in medicine. cardiologist and immunologist. For more than 16 years, he worked in management positions at Bristol-Myers Squibb, a U.S. pharmaceutical company, and Novartis, Switzerland. In 2011, he joined R-Pharm as Chief Medical Officer.

Executive Director, 2012 – present, Association InPharma. In 2012, Vadim Kukava was offered the position of Executive Director of the Association of leading global innovative pharmaceutical companies, InPharma. During this time, the Association has become a key player in the Russian pharmaceutical market, collaborating with government bodies to develop balanced regulations of the industry for the benefit of Russian patients.

From 2006 to 2012, Vadim worked in leading international consumer goods companies in positions related to public/GR relations and policy affairs. He participated in discussions on key legislation in the regulation of the tobacco and medical industries, collaborated with representatives of the Russian and European scientific communities, and played an active role in industrial associations, including serving on the Board. He was also responsible for creating and developing a division for public and regulatory affairs
.
From 2004 to 2006, he worked as a consultant at the Federal Agency for State Property Administration (Rosimuschestvo), responsible for implementing the full range of ownership powers related to property within the forestry and chemical industries owned by the Russian Federation.

Deputy Head of Department of Inspection of Drug Manufacturers, State Institute of Drugs and Good Practices of the Ministry of Industry and Trade, Lead GMP Inspector. Nadezhda has worked in the pharmaceutical industry for more than ten years with experience in API and various dosage forms manufacturing. She joined the Russian GMP Inspectorate in 2015. Nadezhda currently works in the Department of Inspection, providing scientific and methodological support to inspectors. In addition, she conducts GMP inspections in various regions of the world. She received her Master of Science degree in Biotechnology from Saint-Petersburg Chemical-Pharmaceutical University and a B.S. in Biochemical Manufacturing (biosynthesis of antibiotics) from Chemical-Technological College.

Head of Division of Inspection of Foreign Pharmaceuticals Manufacturers, FSI "SID&GP", 2017 — present. From 2012 to 2017, worked at a pharmaceutical manufacturing site. More than 8 years of experience inspecting drug manufacturers.

Deputy Head, Division of Pharmaceutical Inspectorate Training, FSI “SID & GP” since 2020; before that, Radiopharmaceuticals manufacturing, 100+ inspections carried out.

Head of Regulatory, Sun Pharma Eurasia (Russia, Kazakhstan, Belarus, Uzbekistan). Before joining Sun Pharma, Ruslan worked in consulting agencies as Head of Regulatory. He also worked in the Scientific Center for Expertise and Medical Care of the Ministry of Health of the Russian Federation as a pharmaceutical expert. Master of Chemistry. Good knowledge in chemical science.

Head, Medicine Manufacturers Inspection and Enforcement Desk, Ethiopian FDA. I have been working at Ethiopian FDA as dossier assessor, GMP inspector, Desk Head. I graduated with BSc Pharmacy and MSc in Regulatory Affairs. I will be shared separately.

General manager ANO "National Scientific Center for Pharmacovigilance"

Director General of Food and Drug Department, Ministry of Health, Laos.

• Pharmaceutical regulation and policy development
• Good Manufacturing Practice Inspection Committee
• Drug quality control and pharmacovigilance
• Regional and international collaboration on standards and quality of health products
• Leadership in public health administration
• Strategic planning and project management
• Regulation and supervision of food, drugs, and medical products control system in Lao PDR
• Contribution to drug regulatory affairs, including drug registration, quality control, and pharmacovigilance
• Policy development and implementation to ensure public health safety and quality standards
• Chair of National Essential Drug Committee, Ministry of Health, Lao PDR
• Member of Procurement Committee for Drugs and Medical Products, contributing to procurement and quality assurance of pharmaceuticals and medical products for public health facilities
• Chair of ASEAN Consultative Committee for Standards and Quality - Pharmaceutical Product Working Group (ACCSQ-PPWG), June 2023 – June 2024
• Member of Management Committee for Good Manufacturing Practice (GMP) Pharmaceutical Inspection
• Evaluator for Drug Registration (Marketing Authorization Approval)
• Contribution to the development and enforcement of GMP standards for pharmaceutical manufacturing
• Focal Point of National Drug Regulatory Authority for Anti-Counterfeit and Substandard Medicines

Director of the Inspection Division, General Directorate of Inspection, Ministry of Public Health of Uruguay Ms. Cecilia Martinez is a pharmacist and clinical biochemist, graduated from the University of the Uruguay Republic. She received advanced training in Health Services Management (PDS, University of Montevideo), Regulatory Impact Analysis (IDB), MERCOSUR Regulatory Frameworks, and Senior Public Management. Pharmacy Specialist (Academy of Health Sciences, Texas, USA). Led the implementation of the ISO 9001:2015 Quality Management System at the General Directorate of Inspection. Implemented and coordinated the Hospital Pharmacy Course at the Central Hospital of the Armed Forces. Has additional training in WTO Technical Barriers to Trade, Risk Analysis, and Good Manufacturing Practices (GMP) for medicines and medical products. Work experience: Coordinator of the Health Products Committee of MERCOSUR Sub-Working Group No. 11 on Health (SGT 11). Member of the technical team for the establishment of the Sanitary Surveillance Agency of Uruguay
Uruguay’s Focal Point in the MERCOSUR. Pharmacopoeia Subcommittee. Supervisor of the internship program for students of the Pharmaceutical Chemistry and Clinical Biochemistry degrees at the University of the Republic

Deputy Head of the Department of Pharmaceutical Manufacturing Inspection FSI "SID & GP"

Head of Drug Control and Inspection Department
Jordan Food and Drug Administration (JFDA)
Dr. Mahmoud Alqawasmeh had multiple inspections of Korean pharmaceutical companies, which allowed them to enter the MENA markets with income of more than $ 70,000,000. Developed the inspection approach at JFDA, which was rewarded by entering the PIC/S Membership on Nov 5th, 2025. Executive Consultant at South Korea MOHW, 2015−2020

Head of Research and Manufacturing Division, FSBI "NMRRC" of the Russian MoH
Previous work experience: Head of GMP Lab, FSBI "NMRRC" of the Russian MoH. Surgeon and Postdoc, University Hospital of Basel (Switzerland). A specialist in the development of advanced therapeutic medicinal products, leading projects to create Russia’s first biomedical cell-based therapies—CAR-T cell therapy, oncolytic vaccines, and other cutting-edge treatments. An architect of programs for localization, regulatory integration, and clinical implementation of innovative biotechnologies.

Director Center for State Control of Medicines,
Equipment and Medical Devices, Cuba (CECMED)
Professional with more than 30 years of
experience in the field of medicines regulations. Founder of the Area of vaccines, biological and biotechnology products of CECMED WHO/PAHO expert in vaccines and leader of the Vaccines Group of the Pan American Network for Drug Regulatory Harmonization (PANDRH). Coordinator of the ANVISA-CECMED Regulatory Technical Committee for the regulatory support of the Technology Transfer of Biopharmaceutical Products Cuba - Brazil 2005-2019.

S.Si., M.Sc. Apt. Acting Director of Directorate of Control of Production of Drugs, Narcotics, Psychotropics, and Precursors, Indonesian Food and Drug Authority (Badan POM). Over 15 years of experience in regulatory assessment and GMP inspection of biological products, including vaccines, monoclonal antibodies, and advanced therapy medicinal products (ATMPs). Actively involved in policy development, inspection capacity building, and international collaborations under the Pharmaceutical Inspection Co-operation Scheme (PIC/S).