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Regulatory – How to Submit a Combination Product OR Drug Device Combination Globally

Track:
A New Era for Medical Devices and Diagnostics. How Is The Impact?

Day & Time:
April 18, 2:00PM - 3:00PM (Central Europe Standard Time)

Session Number:
S0702

Type:
Session

Title:
Regulatory – How to Submit a Combination Product OR Drug Device Combination Globally

Chair(s):
Manfred Maeder, PhD
Head of Device Development & Commercialization
Novartis, Switzerland

Description:
Regulatory – How to Submit a Combination Product OR Drug Device Combination Globally

Presentation(s) & Speaker(s):
Global Perspective for a Drug Device Combination Product Submission
Chin-Wei Soo
Global Head, PTR Combination Products/Devices
Genentech, United States

The Importance of Science and Regulation
Tim Chesworth
Senior Director Regulatory Affairs
AstraZeneca, United Kingdom