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Dr. Matthias Brunner, Drug Regulatory Affairs Consultant

Worked for more than 15 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 engagements as expert lecturer at training courses for 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 peptid sequencing and detection, and basic research on ‘Bio-chips’.

Studied Toxicology at the University of Leipzig.

Studied Chemistry at the University of Heidelberg and the University of Bristol (UK).

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