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
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Yelena Denisova
Deputy Director of Department of Pharmaceutical and Medical Industry Development of the Ministry of Industry and Trade of the Russian Federation
SPEAKERS
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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
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Dmitry Somov
Director General a.i. of the Federal State Budgetary Institution «IMTSEUAOSMP» of the Federal Service for Supervision of Healthcare (Roszdravnadzor)
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Tatyana Zagumennikova
FSI “SID and GP” of the Ministry of Industry and Trade of the Russian Federation
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Alexander Stepanov
Deputy General Director of Generium JSC
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Adel Sattarova
Head of the Project Department, the SPbSRIVS of the FMBA of Russia
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Mohammed Yusuf
Director General of Bangladesh Medicines Administration General Directorate