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
  • International regulatory landscape – state of play for combination product guidance document
  • EU: MDR Overview of article 117 impact on Industry
  • Roadmap of industry advocacy work and feedback
  • Potential Implementation provisions and next steps
View Details

2nd Annual Drug/Device
Combination Products Summit 2019

Get up to date with the regulatory and quality compliance strategies for combination product development.
  • 04 Dec 2019
  • Prague, CZ
  • Pharma
Day 1: Wednesday, 04 December 2019
BLOCK: NAVIGATING THE EVOLVING REGULATORY LANDSCAPE.
CASE STUDY: The update on the advocacy activities and general regulatory landscape.
  • Where are we with MDR Article 117 implementation?
  • NB capacity issue, has it been solved?
  • Key Industry comments/questions on EMA Q&A on MDR Article 117 implementation and interaction with EMA on this topic
  • Key Industry comments on EMA draft guideline on dossier requirement for drug-device combination products. And reflections on end to end control strategy
  • Industry position on clinical evaluation and labeling requirement for drug-device combination products
  • What to submit in a technical dossier to Notified Body, in what timeframe?
View Details