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Impact of the New EU General Pharma Legislation on Combination Products
Session Chair(s)
Thomas Wejs Møller, MBA, MSc
Director Global Regulatory Affairs - Devices
Novo Nordisk, Denmark
Continuing the previous discussion, this session will explore the potential impact of the new EU General Pharma Legislation on Combination Products focusing on lifecycle management, particularly on limitations/challenges of the existing variations guidelines vs. variations revision/regulation with the new draft of the GPL in mind.
Speaker(s)
Amanda Matthews
Pfizer R&D UK, Ltd, United Kingdom
Senior Director, GCMC for Combination Products & Medical Devices
Christelle Bouygues, PharmD
European Medicines Agency, Netherlands
Regulatory Affairs Senior Officer
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