Seminars, Topic : Biodrugs

Description

Saturday, January 16 2020

10:00 – 10:05 Opening remarks from the organizers

10:05 – 10: 15 Reminder of the objectives of the session and of the work already carried out in Algeria

• Kamel Mansouri, Director General, ANPP

10:05 – 10:30 Introduction and review of definitions and characteristics: Biomedicines & generics

• Francis Megerlin

10: 30 – 12: 00 Regulation, guidelines, evaluation and registration of Biomedicines

• European case : Pr. Jean-Hugues Trouvin
• United States case: Pr. Ruth Lopert
• Jordan / MENA case: Ph. Ahlam Abdelaziz
• WHO recommendation: Nabil Menasria

13:30 – 14:30 Process of developing comparability studies and application

• Ahlam Abdelaziz

14:30 – 16:00 Switch, Interchangeability and extrapolation

• European case : Jean-Hugues Trouvin
• United States case: Pr. Ruth Lopert
• Jordan / MENA case: Ph. Ahlam Abdelaziz

16: 00 – 17: 00 Question and answer sessions

Saturday , 23 January 2020

10:00 – 10:05 Opening remarks from the organizers

10:05 – 10: 15 Reminder of the objectives of the session

• Kamel Mansouri, Director General, ANPP

10:05 – 10:30 Biodrugs pricing policy

• Francis Megerlin

10: 30 – 11: 15 Traceability and Pharmacovigilance of biomedicines

• Michael Muenzberg

11:15 – 12: 00 Comparative studies and clinical trials for biomedicines

• Ahlam Abdelaziz

13:30 – 14:30 Risk management plan

• Michael Muenzberg

14: 30 – 15: 30 Good practices in the production of biomedicines

• Michael Muenzberg

15:30  – 16:30  Questions and clarification sessions