Panel session
Main hall
Panel session
APPROACHES TO LICENSING THE MANUFACTURE OF MEDICINES
Questions and topics for discussion:
- Current requirements for licensing the production of medicines and periodic confirmation of compliance as an integral part thereof
- Licensing and GMP certification of quality control laboratories and other outsourced organizations performing separate stages. Approaches in different regions of the world
- Regulatory approaches to ensure compliance with licensing requirements by manufacturers of medicines (preventive measures and unscheduled control (supervisory) measures)
- WHO pre-qualification experience
- International experience in licensing the production of medicines
MODERATORS
Yelena Denisova
Deputy Director of Department of Pharmaceutical and Medical Industry Development of the Ministry of Industry and Trade of the Russian Federation
SPEAKERS
Gelena Grosheva
Head of the Department for Licensing and Inspection of the Production of Medicines of the Ministry of Industry and Trade of the Russian Federation
Dmitry Somov
Director General a.i. of the Federal State Budgetary Institution «IMTSEUAOSMP» of the Federal Service for Supervision of Healthcare (Roszdravnadzor)
Tatyana Zagumennikova
FSI “SID and GP” of the Ministry of Industry and Trade of the Russian Federation
Alexander Stepanov
Deputy General Director of Generium JSC
Adel Sattarova
Head of the Project Department, the SPbSRIVS of the FMBA of Russia
Mohammed Yusuf
Director General of Bangladesh Medicines Administration General Directorate