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EU Business and Data Needs Converge Thru Telematics
Air Date: Feb 17, 2020Vision for EU Telematics: IT collaboration delivering cost-effective and interoperable services to Europe’s regulatory stakeholders
Speaker(s)
Dr. Bernd Misselwitz
Director, Regional Head Regulatory Submissions
Bayer AG
Dr. Bernd Misselwitz is Director, Regional Head Regulatory Submission Management, at Bayer AG, Germany. He joined former Schering AG as 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 eSubmission Focus Group of EFPIA (European Federation of Pharmaceutical Industries and Associations) and is the Deputy Topic Lead for EFPIA in the ICH M8 Expert Working Group (implementation and maintenance of eCTD) and the EU eCTD Maintenance Group.