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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

Room Number:
Darwin

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
Stephanie Horn, DrSc
Technical Regulatory - Device and Combination Products
F. Hoffmann La Roche Ltd., Switzerland

Coordination for Submissions of Combination Products in the EU
Elisabeth Kapeller
Senior Manager, Regulatory Devices Group
Sandoz, Austria