Panel session
Main hall
Parallel Event
SPECIFICS OF ENSURING COMPLIANCE WITH THE GMP GUIDELINES IN THE PRODUCTION OF CERTAIN TYPES OF MEDICINES
RUSSIAN AND INTERNATIONAL PRACTICE
Questions and topics for discussion:
- Innovations and state-of-the-art technologies in the pharmaceutical industry in the production of sterile medicines
- Single-Use Systems: Risks. Focused on while inspecting
- Specifics of ensuring the safety of high-tech medicines (ATMPs). What the developer needs to consider
- Control systems of biological products
- Practical challenges of implementing risk analysis of elemental impurities
- Extractable and leachable substances: requirements and approaches
- Shared manufacturing facilities for solid dosage forms. Experience in applying a risk-based approach
MODERATORS
Nadezhda Arkhipova
Deputy Head of the Directorate for Inspection of Medicines Manufacturers, Federal State Institution “SID and GP”, Ministry of Industry and Trade of the Russian Federation
SPEAKERS
Alexandra Taube
Leading Researcher, Institute for Research and Development, Federal State Budgetary Institution ‘SCEEMP’ of the Ministry of Health of Russia
Jesus Herrera
Head of Directorate for Medicinal Products and Cosmetics, Autonomous Health Control Service, Bolivarian Republic of Venezuela
Naala Grivapsh
Corporate Quality Director, Binnopharm Group
Roman Karasyov
Chief Qualified Person for Quality, Gedeon Richter-Rus
Faiza Yagudina
Quality Director, Akrikhin
Vyacheslav Goryachkin
Adviser on quality issues and technology transfers, Skopinfarm LLC
Ali Al-Muhsin
Senior Products and Facilities Inspection Expert, Saudi Food and Drug Authority, Kingdom of Saudi Arabia