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Dr. Matthias Brunner, Drug Regulatory Affairs & QA Consultant

… worked for 20 years in several companies in drug regulatory consulting, the pharmaceutical industry and the German Federal Institute for Drugs and Medical Devices (BfArM) with an in-depth focus on pharmaceutical quality and Module 3 for new Marketing Authorisation Applications (MAA, NDA), Clinical Trial Applications (CTA, IMPD, IND), Variations/Changes and medicinal product development.

… had been engaged as expert lecturer at training courses on Regulatory CMC topics like Module 3 writing.

… initiated and drafted a pharmacopeial text for Germany and EU on Microbiological Requirements for Unpreserved Dosage Forms in Multi-Dose Containers, in cooperation with pharmaceutical companies, primary container manufacturers, microbiological laboratories, authority members and independent experts.
(official version of 26 Feb. 2009, PDF, 22 kB)

… worked in Life Sciences research on DNS and peptide labelling, sequencing and detection, and fundamental research on 'Bio-chips'.

… studied Chemistry at the University of Heidelberg and the University of Bristol (UK), and Toxicology at the University of Leipzig.

A portrait was issued in the VAA Magazin 2013/1 (Feb. 2013, in German, p.20), publicly accessible.