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BioProcess International Europe

Poster Submission Deadline is April 7

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Mark Your Calendar for BPI Europe 2023!
9-12 May 2023RAI in Amsterdam

Romain Le Deun
Director, Regulatory Affairs CMC at Moderna


Romain Le Deun is a biotechnology engineer, holding the position of Director, Regulatory Affairs CMC - International at Moderna Switzerland GmbH. He graduated from the INSA Lyon Engineering School, France (2006). Over the last 15 years, he worked in regulatory affairs for several pharmaceutical companies (VCLS, Genzyme Polyclonals, Baxter and Merck Serono) specializing on CMC components of regulatory filings for small molecules, recombinant proteins, cell-based products and mRNA lipid nanoparticles. He has been extensively involved in the management of CMC data required to support medicinal products life cycle from Phase I to registration and post-market activities. He recently participated in the development of a QbD Guide for the A3P association.

Agenda Sessions

  • Integrating mRNA Technology Specificities to the Regulatory Evaluation Approach