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Dr. Annegret Vaggelas

Consultant

Dr. Annegret Vaggelas is a highly skilled regulatory affairs professional with several years of experience. 

Annegret’s know-how in regulatory project management, her scientific background as well as her medical writing capabilities have been successfully utilized in many biologics and ATMP projects at Biopharma Excellence. Furthermore, she has gained experience with first in class small molecules. Annegret prepared various documents for regulatory submission such as clinical trial applications and marketing authorizations (IMPD, IND, IB, benefit-risk assessment, QOS, and 3.2.R biosimilarity assessment report, whitepapers). She also has extensive experience in preparing documents for GMO-related submission, writing environmental risk assessments and preparing new substance notifications (NSNs) for Canada. Moreover, Annegret is regularly involved in the preparation of scientific advice as well as PRIME procedures including authoring and compiling relevant briefing documentation. She also advises clients on an ongoing basis during the whole product development lifecycle. 

Annegret received her degree in veterinary medicine from the Ludwig-Maximilians-University and completed her PhD at the Max-von-Pettenkofer Institute for Hygiene and Clinical Microbiology, both in Munich. During her PhD she gained broad experiences in the development of diagnostic assays and filed together with her supervisor a patent for a method for the diagnosis of infectious diseases. Annegret gained training in regulatory affairs at the European Centre for Regulatory Affairs (EUCRAF) and by working as a student assistant at Biopharma Excellence during her PhD time. She also participates in the European Medical Writers Association (EMWA) Professional Development Programme (EPDP), which provides a high-quality training for medical writers.