12:30 – 14:00

Обед

9:00 - 09:30

Registration and Morning Coffee

16:00 – 16:30

Coffee Break. Networking

17:30

11:00 – 11:30

Coffee Break

13:00 – 14:00

Lunch

9:30 – 11:00

Theme: Approaches to GMP inspection of biological drug products
Speakers:
Dr. Jean-Denis Gérard Mallet, Senior Pharmacist, QP, GMP Consultant
Presentation Title: Inspection of biological processes (fermentation) 
George Derzskiy, Deputy Head, Pharmaceutical Inspectorate Training and Development Division, FSI "SID & GP"
Presentation Title: Subsequent stages of biological drug manufacturing and inspection

Theme: Manufacturing and quality control of biological drug products
Speakers:
Dr. Mikhail Samsonov, MD, PhD, Chief Medical Officer, R-Pharm Group
Presentation Title: Innovative biologicals: 1st hand global experience
Anna Lakhtanova, Chair, AIPM Regulatory Committee 
Presentation Title: Out of specification issue for the cell-based products. Reasons and ways of resolving.
Kira Zaslavskaya, Director, New Products, PROMOMED Group, Member of the Board of Directors
Presentation Title: ATMP Regulatory Issues

Moderator:
Denis Baranovsky, Head, Scientific and Production Complex for Biotechnology, State Institution "National Medical Research Radiological Centre of the Ministry of Health of the Russian Federation"

11:30 – 13:00

Themes: Mutual recognition of results of GMP inspections: regulatory reliance, assessment and equivalence of regulatory systems; 
Information exchange between the national regulatory authorities during issuance of GMP certificates: minimum content requirements for GMP inspection report and required additional information

Speakers: 

• Dr. Medard Kab Bitekyerezo, Chairman, National Drug Authority

Presentation Title: Mutual recognition of results of GMP inspection

• Dr. Bounxou Keohavong, Director General, Food and Drug Department, Ministry of Health of Laos
• Lisette Elda Perez Ojeda, Advisor to the Director, Center for State Control of Medicines, Medical Devices and Medical Supplies (CECMED)

Presentation Title: Recognition of GMP Certificates Based on Regulatory Authority Guarantee

• Cecilia Martinez Rossi. Head of the Inspection Department, Ministry of Health of Uruguay

Presentation Title: Regulatory Reliance

• Dr. Shaikha Al Mazrouei, Director of Reference National Laboratory, Drug Department, Emirates Drug Establishment

Moderators: 
Pavel Karpov, Deputy Head, Pharmaceutical Inspectorate Cooperation Division, FSI "SID & GP"
Yulia Grishina, Deputy Head, Pharmaceutical Inspectorate Cooperation Division, FSI "SID & GP"

14:00 – 15:50

Theme: Overview of regulatory requirements (regulatory landscape of countries)  

• Dr. Shaikha Al Mazrouei, Director of Reference National Laboratory, Drug Department, Emirates Drug Establishment
• Shanti Marlina Sibuea, Acting Director, Drugs, Narcotics, Psychotropics, and Precursors Production Control, Indonesian Food and Drug Authority (BPOM)
• Dejene Daba Dibaba, Head, Medicine Manufacturers Inspection and Enforcement Desk, Ethiopian Food and Drug Authority (EFDA)

Theme: Foreign market entry for pharmaceuticals: pharmaceutical companies’ experience 
Speakers:

• Ruslan Suleymanov, Head, Regulatory Division, Sun Pharma Eurasia
• Nikita Punia, Vice-president of commerce, Pharmasyntez group

Presentation Title: The experience of Pharmasyntez Group in bringing medical products to foreign markets: obstacles and solutions 

• Fu Bainian, Vice President, China Association for Vaccines

Presentation Title: Overview of the vaccine industry in China 

Moderator:
Vadim Kukava, Executive Director, Association Infarma

16:30 – 17:30

Moderators:

Anna Derkach, Head, Division of Inspection of Foreign Pharmaceutical Manufacturers, FSI "SID & GP”

George Derzskiy, Deputy Head, Pharmaceutical Inspectorate Training and Development Division, FSI "SID & GP"

15:50 - 16:00

15:30 – 16:00

Networking 

9:00 - 09:30

Registration and Morning Coffee

09:30 - 10:00

Exhibition Tour

18:00

Evening Reception

13:00 - 14:00

Lunch

10:00 - 10:30

Welcome Speech 

12:30 – 13:00

Group Photo. Press Conference. Networking

10:30 – 12:30

Theme: Regulatory harmonization of pharmaceutical manufacturing: trends in regional unions

Speakers:

• Siarhei Seradziuk, Deputy Director, State Institution “Gosfarmnadzor”
• Dr. Taruna Ikrar, Chairperson, Indonesian Food and Drug Authority
• Washington Dengu, GMP Inspections Coordinator, African Medicines Regulatory Harmonisation (AMRH)

Theme: Ensuring access to innovative pharmaceuticals: ways to provide it in different countries

Speakers:

• Dr. Wesal Al Haqish, Director General Technical Assistant, Jordan Food and Drug Administration (JFDA)
• Dmitry Galkin, Director, Department of Pharmaceutical and Medical Industry Development, Ministry of Industry and Trade of Russia
• Dr. Olga Lidia Jacobo Casanueva, Director, Center for State Control of Medicines, Medical Devices, and Medical Supplies (CECMED)

Moderator: 
Dr. Mahmoud Fawaz Seatan Alqawasmeh, Deputy Director of the Drug Directorate, Head of Drug Control and Inspection Department, Jordan Food and Drug Administration (JFDA)

14:10 – 15:30

Speaker:
Natalia Burlakina, Deputy Head, Department of Pharmaceutical Manufacturing Inspection, FSI "SID & GP"

Theme: Working Group on Requirements for manufacture of sterile medicinal products: SUS and closed systems, Contamination Control Strategy, GMP inspection
Speakers:
William Peterson, Director of Quality Assurance - Sterility Assurance, MSD Pharmaceuticals (Virtual)
Presentation Title: Closed systems (Annex 1 of GMP rules)

Shanshan Liu, Technical Director of No deviation Pte. Ltd
Presentation Title: Effective Contamination Control Strategy (CCS)

Moderator:
Nadezhda Arkhipova, Deputy Head, Department of Pharmaceutical Manufacturing Inspection, FSI "SID & GP"
Parallel Event
Theme: VR Pharm Factory for industry (Presentation)