Co-Chair, IFPI Expert Committee. 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 obtained
diplomas after completing professional training programs on GMP inspection/audit, international WHO certificate (GMP inspection, Quality Management System for national regulatory authorities). Since 2016, Vladislav Shestakov has been the Deputy Head of the Russian GMP Inspectorate, and the Head of the Good Practices Committee of the Council for Professional Qualifications in Pharmacy of the National Pharmaceutical Chamber. Vladislav Shestakov is the author/co-author of 11 patents, 61 publications, monographs "What is acceptable and unacceptable in pharmaceutical manufacture" and "GMP Standard. Case Studies", which are training and reference guidance for pharma industry specialists.
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).
Dr. Shanti Marlina Sibuea,
Deputy Director General, Food and Drug Administration, Myanmar. Regulatory Experience – 30 years. Deputy Director General (2021–current). Director of Drug Department (2014–2021)
Inspector’s experience – 23 years
- Training of GMP Inspectors (Hands-on Training for Newly Recruited Inspectors)
- e-Submission System for Pharmaceuticals
- Adverse Drug Reaction Guideline
- ACTD, ACTR Implementation for Registration
- Member of ASEAN MRA GMP
Chair, IFPI Expert Committee Founder and CEO of Al Kenz Pharmaceutical Prod. and Yash Scientific Office. More than 25 years of experience in the pharma sector across the UAE and the wider Gulf region.
Head of the Department of Pharmaceutical Inspection, Ministry of Health of the Republic of Belarus. Regulator in the field of medicinal product circulation (Head of the Pharmaceutical Inspectorate, Ministry of Health of the Republic of Belarus). Development of a pharmaceutical quality system within the Ministry of Health, including drafting regulatory documents related to the circulation of medicinal products, their practical implementation, and validation.
Participant to be confirmed
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.
Mrs Olga Lidia Jacobo Casanueva