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Session 7: Global Regulatory Changes and Emerging Markets
Session Chair(s)
Ryan McGowan
Associate Director, Combination Products
AstraZeneca, United States
Kirsten H. Paulson, MS, RAC
Pfizer, Inc., United States
The global landscape for combination products is constantly changing. New regulations and polices are emerging within key international markets and it is essential that companies understand expectations to ensure successful marketing and change management strategies. This session will cover the new EU Medical Device Regulation and its impact on combination products as well as an overview of international combination product regulation within emerging markets.
Learning Objective : Upon completion of this session, participants should be able to:- Define a combination product in major international markets
- Recognize the importance of compliance with the EU MDR and specific provisions on combination products
- Understand high-level expectations of international health authorities regarding combination products
Speaker(s)
Combination Product Regulation in Emerging Markets
Ola Oyinloye
AstraZeneca, United States
Associate Director - Medical Devices and Combination Products
EU Medical Device Regulation and Impact on Combination Products
Sarah H. Stec
Johnson & Johnson, United States
Senior Counsel, Regulatory Law