Serge Mathonet, Sanofi R&D - Qepler Summits And Conferences

Serge Mathonet

Global Regulatory Affairs CMC Biologics - Site Leader
Sanofi R&D
Chilly Mazarin, France
Sanofi R&D

Serge is a global regulatory affairs group leader with more than 14 years of regulatory affairs experience in Chemistry, Manufacturing and Controls (CMC) focusing on biologics and biologics/device combination product development, licensing and launch/life cycle management activities. Prior to joining Global Regulatory Affairs, Serge has held various positions in Sanofi Industrial Quality Operations in API Regulatory Compliance activities either at corporate or industrial site level.

Serge is a core member of EBE Biomanufacturing group leading the combination product topic groups advocating in coordination with 7 Industry groups - Medtech and Pharma.

Related Sessions:

Drug/Device Combination
Products Summit 2018

Get up to date with the regulatory and quality compliance strategies for combination product development.
  • 04 Dec 2018
  • Berlin, DE
  • Pharma
Day 1: Tuesday, 04 December 2018
BLOCK: NAVIGATING THROUGH REGULATORY COMPLEXITY.
CASE STUDY: MDR Article 117 implementation and impact on DDC’s / CMC dossier content strategy and device Post-approval change management

MDR Article 117 implementation and impact on DDC’s

  • Overview of article 117 impact on Industry
  • Roadmap of industry advocacy work and feedback
  • Next steps and implementation

CMC dossier content strategy and device Post-approval change management

  • Device specific content strategy for DDC’s
  • A view on post approval change management
  • Industry and Agency alignment
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