Biodrugs Seminar
16th January & 23rd January
Topics
Review of the definition and regulation of EMA / FDA / JFDA biomedicines
Biosimilar vs Generic
Importance of the issue of efficiency and safety, quality control
Extrapolation, switch, interchangeability
Biosimilar pricing policy
Production of biosimilars
Comparability studies
Post-market surveillance
Risk management plan
Comparative studies and clinical trials
Details :
- Organization by videoconference (Zoom)
Participants: members of the Algerian Medicines and Pharmaceuticals Agency, Ministry of Pharmaceutical Products, Center of Pharmacovigilance
Recording of the session
Speakers
- Pr. Ruth Lopert, independent consultant in global health, pharmaceutical policy, and health technology assessment
- Philippe Megerlin, Health Laws & Systemics
- Michael Muenzberg, global Consultant for Biosimilars, Member of the Comparative Outcomes Group
- Ph. Ahlam Abdelaziz, Head of Sera & Vaccines Subdivision Jordan Food & Drug Administration
- Nabil Menasria, OMS Algerie
- Pr. Jean Hughes Trouvin, Professor at the Faculty of Pharmacy, Paris-Descartes University
Pr. Ruth Lopert
Independent consultant in global health, pharmaceutical policy, and health technology assessment
Philippe Megerlin
Health Laws & Systemics
Michael Muenzberg
Global Consultant for Biosimilars, Member of the Comparative Outcomes Group
Ph. Ahlam Abdelaziz
Head of Sera & Vaccines Subdivision Jordan Food & Drug Administration
Nabil Menasria
OMS Algerie
Pr. Jean Hughes Trouvin
Professor at the Faculty of Pharmacy, Paris-Descartes University
