SEMINAR
Biodrugs
16th January & 23rd January
Session program
About this session
16th January & 23rd January
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
Participants: members of the Algerian Medicines and Pharmaceuticals Agency, Ministry of Pharmaceutical Products, Center of Pharmacovigilance
Attending experts
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