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Global Pharmaceutical Regulatory Affairs Summit
22-24 October 2024
Sheraton Brussels Airport, BrusselsHybrid Event

Bernd Misselwitz
Senior Director, Regulatory Submissions at Bayer


Dr. Bernd Misselwitz is Senior Director, Regional Head Regulatory Submission Management, at Bayer AG, Germany. He joined former Schering AG as Senior Scientist in Contrast Media Research in 1995 before he moved to Submission Management in 2009. Bernd has extensive regulatory and telematics experience with all European submission procedures and different submission formats, including requirements in other ICH and Non-ICH countries. He is representing Bayer in the ERAO (European Regulatory Affairs & Operations) eCTD Subgroup of EFPIA (European Federation of Pharmaceutical Industries and Associations) and is the Topic Lead for EFPIA in the eCTD IWG (Implementation Working Group) of ICH M2.

Agenda Sessions

  • A Deep Dive on eCTD 4.0: Where Are We Now – What Will Come Next?

  • Industry Panel: Practicalities of Implementing eCTD 4.0

  • Big Picture Panel: The Future of eCTD and Beyond