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Early Access CMC Approaches: EMA Toolbox Guidance 2021
Session Chair(s)
Diane Wilkinson, PhD, RPh
Executive Director, Global CMC Regulatory Affairs
AstraZeneca, United Kingdom
Mats Welin, MPharm
Senior Expert
Medical Products Agency (MPA), Sweden
The focus of this session will be on the EMA CMC toolbox guidance, which is due to be published for consultation in Q1 2021. This toolbox covers scientific and regulatory tools, available in the EU regulatory framework, that can be used by applicants to address challenges commonly experienced when completing Module 3 data requirements for PRIME applications. It follows on from the Workshop with stakeholders on support to quality development in early access approaches (i.e. PRIME, Breakthrough Therapies), held jointly with the US Food and Drug Administration (FDA) in 2018, and subsequent report 2019. There will be panel discussion with representatives from EMA, FDA and Industry to look at these proposals and next steps.
Speaker(s)
Industry Perspectives: Benefit-risk Evolution Not Revolution; Support and Desired Next Steps
Markus Goese
F. Hoffmann-La Roche Ltd, Switzerland
Head EU CMC Regulatory Policy
Title to be Announced
Sean Barry, PhD
Health Products Regulatory Authority (HPRA), Ireland
Senior Pharmaceutical Assessor
Reflections from FDA
Laurie Graham
FDA, United States
Director, DIPAP, OPPQ, OPQ, CDER
Panelist
Marcel Hoefnagel, DrSc, PhD, MSc
Medicines Evaluation Board , Netherlands
Senior Assessor Biopharmaceuticals
Panelist
Mahesh R. Ramanadham, PharmD, MBA
FDA, United States
Deputy Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER
Panelist
Matt Popkin, PhD
GSK, United Kingdom
Senior Director, CMC Excellence, Global Regulatory Affairs
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