Ask your question
Expert Committee
Chair of the 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.
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.
Mr. Vladislav Shestakov
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).
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..
Developed and implemented the following processes
Regulatory Experience – 30 years..
Developed and implemented the following processes
- 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
Dr. Theingi Zin
Head of the Department of Pharmaceutical Inspection, Ministry of Health of the Republic of Belarus.
Ms. Lavnik developed 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.
Ms. Lavnik developed 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.
Ms. Elena Lavnik
Lead Executive Officer, Medicine Manufacturer Inspection and Enforcement
Ethiopian Food and Drug Authority
Regulatory professional in pharmaceutical manufacturing inspection, GMP compliance, Quality Assurance and regulatory enforcement at the Ethiopian Food and Drug Authority. Expert in GMP/GCP of the African Medicines Agency.
Have led GMP inspections for more than 150 pharmaceutical manufacturing facilities, strong technical expertise in GMP Inspection, report writing, review and evaluation, CAPA assessment, Root cause analysis, Data integrity evaluation and Pharmaceutical Quality System in-depth evaluation.
Ethiopian Food and Drug Authority
Regulatory professional in pharmaceutical manufacturing inspection, GMP compliance, Quality Assurance and regulatory enforcement at the Ethiopian Food and Drug Authority. Expert in GMP/GCP of the African Medicines Agency.
Have led GMP inspections for more than 150 pharmaceutical manufacturing facilities, strong technical expertise in GMP Inspection, report writing, review and evaluation, CAPA assessment, Root cause analysis, Data integrity evaluation and Pharmaceutical Quality System in-depth evaluation.
Getachew Genete
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.
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
