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)

12:45 – 14:00

Lunch Break

14:00 – 14:45

Expert Session / Q&A Session

14:45 – 15:00

Coffee and Networking Break

17:00 – 17:30

Closing remarks by Vladislav Shestakov, Director, SID & GP

November 25, 2024

9:00 - 10:00

Registration and Coffee

11:30 - 11:45

Coffee and networking break

10:30 – 12:30

Plenary Session: Development Trends of Pharmaceutical Regulatory System

Wayne Müller, Medicines Control Officer of the South African Health Products Regulatory Authority and GMP Technical Committee Chair of the African Medicines Regulatory Harmonisation
Presentation Title:
Key elements of the pharmaceut ical regulatory system

Dr. Theingi Zin, Deputy Director General of the Department of Food and Drug Administration (Republic of the Union of Myanmar)

Darwin Yaser Marcelo Feliz, Director of the General Directorate of Drugs, Food and Sanitary Products of the Ministry of Health and Social Welfare (DIGEMAPS) (Dominican Republic)
Presentation Title:
Strengthening reliance practices in regulation of medicinal products: international regulatory collaboration between countries

Dr. Ranga Chandrashekar, Joint Drugs Controller of the Central Drugs Standard Control Organisation (CDSCO) (Republic of India)
Presentation Title:
Digitalization in pharmaceut ical regulation: prospects and development trends — artific ia l intelligence

10:00 – 10:15

Welcome Speech

of Dr. Fatima Al Kaabi, Director General, Emirates Drug Establishment

11:45 – 12:45

Plenary Session Continuation

Dmitry Galkin, Head of Department of Pharmaceutical and Medical Industry Development of the Ministry of Industry and Trade of the Russia
Presentation Title: Global regulatory requirem1e nts: should there be any and those who make them

Dr. Medard Bitekyerezo, Chairman of the National Drug Authority (Republic of Uganda)

Lisette Pérez Ojeda, Advisor of the Center for State Control of Medicines and Medical Equipment of the Ministry of Public Health (Republic of Cuba)
Presentation Title: Experiences of regulatory cooperation international between countries

Aziz Dusmatov, Director, State Unitary Enterprise "Center for Good Practices", Agency for the Development of the Pharmaceutical Industry (Republic of Uzbekistan)
Presentation Title: International regulatory harmonization: implementation of international standards into the regulatory system

15:00 – 17:00

Expert Session

Wayne Müller, Medicines Control Officer of the South African Health Products Regulatory Authority and GMP Technical Committee Chair of the African Medicines Regulatory Harmonisation Presentation Title: Implementation of Annex 1 (Manufacture of sterile medicinal products): advantages and difficulties

Yulia Norba GMP Inspector, SID & GP, (Russia)
Presentation Title: Manufacture of sterile medicinal products: lyophilisation processes and associated risks

George Derzskiy, GMP Inspector, SID & GP (Russia)
Presentation Title: Cross Contamination Risks

Vladimir Orlov, Director ISPE Eurasian Economic Union Affiliate, International
Society for Pharmaceutical Engineering (ISPE)
Presentation Title: Role of International Guidelines and Recommendations in Ensuring a Harmonized Approach to the Technical Interpretation of GMP requirements

Banu Refik, Secretary, ISPE 2(Republic of Türkiye)
Presentation Title: Highlights of ISPE's Baseline® Guide: Commissioning and Qualification
Vladimir Smirnov, GMP Inspector, SID & GP (Russia) GAPI working groups

Moderators:
Nadezhda Arkhipova, Deputy Head, Department of Pharmaceutical Manufacturing Inspection, FSI "SID & GP"
Vladimir Orlov, Director ISPE Eurasian Economic Union Affiliate, International Society for Pharmaceutical Engineering (ISPE)