Notified Body Opinion Workshop – Experiences and Lessons for Combination Products in EU

It has been three years since Notified Body Opinions have been required for integral combination products in the European Union (EU) under the requirements of Article 117 of the EU Medical Device Regulations. In the intervening time, both industry and notified bodies have learned more about expectations of these submissions, however key elements also remain uncertain which places some combination products at approval risk due to lack of clarity on expectations. This session will provide an overview of Notified Body Opinions in EU, cover practical considerations and best practices in delivering the submissions, and explore some key areas of uncertainty such as post-approval substantial changes.

Leading Facilitators

• Ryan McGowan, Director, Digital Devices and Combination Products, AstraZeneca
• James Wabby, Global Head – Emerging Technologies, Combination Products, and Devices, Abbvie

Facilitators

• Arabe Ahmed, Bsi Group
• Timothy Chesworth, Senior Director Regulatory Affairs – Devices & Digital Therapeutic, AstraZeneca
•  Katie Chowdhury, Director, Global Regulatory Affair, Emerging Technologies, Digital Medical Devices, & Combination Products, AbbVie
• Amanda Matthews, Senior Director, Regulatory CMC for Combination Products & Medical Devices, Pfizer