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

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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

Contact us

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Tour Sebastopol, 3 Quai Kleber, 67000 Strasbourg

+33 - 388 - 23 - 70 - 92
+33 - 643 - 12 - 95 -13
+213 - 549 - 55 - 62 - 05

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