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Radisson Grand Place

Jan 30, 2024 8:00 AM - Jan 31, 2024 6:30 PM

47 Rue du Fossé aix Loups, Brussels, Belgium

2024 Combination Products in the EU

Impact of the New EU General Pharma Legislation on Combination Products

Session Chair(s)

Thomas Wejs Møller, MBA, MSc

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

Amanda Matthews

Pfizer R&D UK, Ltd, United Kingdom

Senior Director, GCMC for Combination Products & Medical Devices

Christelle  Bouygues, PharmD

Christelle Bouygues, PharmD

European Medicines Agency, Netherlands

Regulatory Affairs Senior Officer

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