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Dr. Annegret Vaggelas

Consultant


Annegret Vaggelas works in different regulatory submissions and strategic projects.

 

  • Scientific Writer (IMPD, IB, MAA documents)

  • Scientific advice procedures

  • Support of development projects

Annegret Vaggelas works in different regulatory submissions and strategic projects. She prepares risk assessments, writes Investigator’s Brochures (IB) and IMPDs, drafts CTD parts such as the Quality Overall Summary or 3.2.R biosimilarity assessment reports and compiles GMO documentation. Additionally, she is involved in the preparation of scientific advice procedures and its relevant briefing documentation and supports benefit-risk assessments including the development of risk mitigation approaches. 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. Her research work was related to new therapeutic and diagnostic approaches for invasive fungal infections. 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 Fusarium infections. Moreover, her research work concentrated on substances that activate the fungal specific high osmolarity glycerol pathway as a means to combat invasive mycoses. Annegret gained training in regulatory affairs by participating in several seminars of the European Centre for Regulatory Affairs (EUCRAF) and by working as a student assistant at Biopharma Excellence.