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The Future of Combination Products in the EU
Session Chair(s)
Maren von Fritschen, PharmD
Head EU Regulatory Policy
Moderna, Netherlands
This forum will focus on the applicability of the new European Medical Device Regulation (EU-MDR) on 26 March 2020. Implications and challenges of the new legal requirements and technical provisions for drug-device combination products will be discussed from the perspective of regulators, industry and patients.
Learning Objective : Describe the complexity and consequences of the new EU Medical Device Regulation for drug-device combination products; Identify the challenges of the new requirements for industry, regulators, and Notified Bodies (NB) e.g. new designation process of Notified Bodies and competent staff, accountability, new technical requirements etc; Describe the challenges against patients' expectations and join the discussion.
Speaker(s)
EMA Perspective
Zahra Hanaizi, PharmD, MPharm
European Medicines Agency, Netherlands
Scientific Officer, PRIME Coordinator, Scientific and Regulatory Management Dept
Industry Perspective
Trine B. Moulvad, MSc
Lundbeck, Denmark
Global RA, Medical Documentation and R&D QA
Patient Perspective
Nicholas Brooke, MBA
PFMD, Belgium
Executive Director, Patient Focused Medicines Development (PFMD)
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