10:35 – 10:55

Strengthening reliance practices in regulation of medicinal products: international regulatory collaboration between countries

10:55 – 11:10

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

11:30 – 11:45

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11:10 – 11:30

Digitalization in pharmaceutical regulation: prospects and development trends — artificial intelligence

Dr. Ranga Chandrashekar

Joint Drugs Controller of the Central Drugs Standard Control Organisation (CDSCO)

Republic of India

Key elements of the pharmaceutical regulatory system

Wayne Matheuw Muller

Medicines Control Officer of the South African Health Products Regulatory Authority and GMP Technical Committee Chair of the African Medicines Regulatory Harmonisation

10:15 – 10:35

10:15 – 11:30

Plenary Session
Development Trends of Pharmaceutical Regulatory System

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

10:00 – 10:15

09:00 – 10:00

November 25, 2024

12:00 – 12:15

Experiences of international regulatory cooperation
between countries

12:15 – 12:30

Lisette Pérez Ojeda

Advisor of the Center for State Control of Medicines and Medical Equipment of the Ministry of Public Health

Republic of Cuba

Doctor Medard Bitekyerezo

Chairman of the National Drug Authority

Republic of Uganda

12:30 – 12:45

International regulatory harmonization: implementation of international standards into the regulatory system

Aziz Dusmatov

Director, State Unitary Enterprise "Center for Good Practices", Agency for the Development of the Pharmaceutical Industry

Republic of Uzbekistan

12:45 – 14:00

14:00 – 14:45

Expert Session
Q&A Session

Moderators:
Nadezhda Arkhipova
Vladimir Orlov

Global regulatory requirements: should there be any and those who make them

Russia

Dmitry Sergeevich Galkin

Head of Department of Pharmaceutical and Medical Industry Development of the Ministry of Industry and Trade of the Russia

11:45 – 12:00

11:45 – 12:45

Plenary Session Continuation

November 25, 2024

Closing remarks by Vladislav Shestakov, Director, SID & GP

17:00 – 17:30

15:40 – 16:00

Cross Contamination Risks

George Derzskiy

GMP Inspector, SID & GP

Russia

15:20 – 15:40

Manufacture of sterile medicinal products: lyophilisation processes and associated risks

Yulia Norba

GMP Inspector, SID & GP

Russia

16:00 – 16:20

Role of International Guidelines and Recommendations in Ensuring a Harmonized Approach to the Technical Interpretation of GMP requirements

Vladimir Orlov

Director ISPE Eurasian Economic Union Affiliate, International Society for Pharmaceutical Engineering (ISPE)

Russia

16:20 – 16:40

Highlights of ISPE’s Baseline® Guide: Commissioning and Qualification

Banu Refik

Secretary, ISPE

Republic of Türkiye

16:40 – 17:00

Q&A Session

Moderators:
Nadezhda Arkhipova
Vladimir Orlov

Implementation of Annex 1 (Manufacture of sterile medicinal products): advantages and difficulties

Wayne Matheuw Muller

Medicines Control Officer of the South African Health Products Regulatory Authority and GMP Technical Committee Chair of the African Medicines Regulatory Harmonisation

Expert Session

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November 25, 2024