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Regulatory – How to Submit a Combination Product or Drug Device Combination Globally
Session Chair(s)
Manfred Maeder, PhD
Head of Device Development & Commercialization, Novartis, Switzerland
Regulatory – How to Submit a Combination Product or Drug Device Combination Globally
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
Regulatory Devices Portfolio Head, Sandoz, Austria
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