Training Schedule

  • 09:15-09:45:    Regulation in EU/US
  • 09:45 -10:00:  Regulations: MENA & GCC
  • 10:00-10:30:   Regulations & Guidelines for Registration & Marketing Authorization of Biosimilars in Morocco
  • 10:30-11:00:   Global Development to meet all Regulators expectations
  • 11:30-12:00: Comparative PK/PD
  • 12:00-12:45:  Phase 3 Safety and Efficacy
    • Safety assessment
    • Statistical consideration/ Historical data
    • End points
    • Safety of Biosimilars since first one launched in the EU
  • 12:45-13:00: Discussion: Challenges & Opportunities in conducting clinical trials for biosimilars
  • 09:00-09:30: Manufacturing Biosimilars
  • 09:30-10:00: Structural and Physicochemical Analysis of Biosimilars
  • 10:00 -10:30: Biologic Activity analysis of Biosimilars
  • 10:30 -11:00: Bio analytical methodology & validation of Biosimilars
  • 12:00-12:15: LMWH
  • 12:15-12:30: Specific approved drug (examples of monoclonal antibodies)
  • 12:30-12:45: Case Study Biosimilars Uptake - Scandinavia
  • 13:45-14:15: The importance of Robust PV systems
  • 14:15-14:45: Post Marketing Surveillance of Biosimilars
  • 14:45-15:15: Risk Management Plans- Originator and Biosimilars
  • 15:15-15:45: Case Study: Epo and PRCA
  • 15:45-16:30: Panel Discussion with all participants and afternoon tea