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Isabelle Colmagne-Poulard

Head of International Global Regulatory & Scientific Policy Merck (Merck KGaA Darmstadt)

Isabelle is a Regulatory/QA executive with over 25 years of progressively responsible experience and accomplishments in the areas of drug and medical device development.
Isabelle has joined Merck since 2005 where she held growing managerial roles in Reg. Affairs and Reg. CMC as Head of Department, based in Switzerland.

Since 2014, she is also very actively involved in regulatory policy as member of EFPIA, PhRMA, IFPMA and the ICH Training subcommittee. In her current capacity as Director of International Global Regulatory & Scientific Policy, she leads the development of Merck International regulatory policy priorities and advocacy agenda.

Prior to joining Merck, she worked for several Companies in areas such as Clinical Development for Servier Laboratories (France) and assumed various manufacturing site managerial responsibilities within Sanofi GMP QA and Regulatory Affairs for 7 years. She is also familiar with medical device and combination products as she headed Global Regulatory Affairs and QA for Nestle Health Science (Switzerland).

Isabelle holds a Master in Biology and Medical Sciences and a Pharm. D from Lyon school of Pharmacy as Industrial Pharmacist, coupled with a Master in Quality Management from Paris High Business School (ESCP).

See Isabelle Colmagne-Poulard at this event

  • Day 2 Wednesday 4 December

Reliance across the product life cycle: PACs & GMPs

09:00 - 10:30 CET / 19:00 - 20:30 AEDT

Session objectives:

  • Discuss how reliance can be implemented for PACs and what tools are available to streamline reliance in this area.
  • Highlight findings from literature, industry surveys and available data to illustrate the complexity of the current global PACs framework.
  • Address challenges and propose solutions to further implement reliance for GMP inspections.