CONVINCING KNOWLEDGE
Dr. Manuel Zahn, founder and managing director of 3R PHARMA CONSULTING, offers expertise in the area of GMP, Regulatory CMC / Quality and stability testing of pharmaceutical products.
Key assets:
- 29 years experience in the pharmaceutical industry (in Germany and Sweden)
- 25 years experience in Regulatory Affairs (world-wide)
- Qualified Person (QP) according to Directive 2001/83/EC, Art. 49 and 51
- APIC Certified Auditor of API manufacturers (ICH Q7)
- Negotiation skills in a cross-cultural environment
- Contributed to the development of two major ICH guidelines, i.e., Stability Testing and Common Technical Document - Quality
- Leading the first submission of an application via the EU Worksharing Procedure for Quality variations, achieving the first European approval of PAT based Real Time Release (published in The Regulatory Affairs Journal Vol 19 (3), 155-159, 2008.
Dr. Zahn is a member of the Editorial Board of SCRIP Regulatory Affairs
Dr. Zahn is a member of the Advisory Board of Pharma iQ
Dr. Zahn is a member of the following organisations:
American Association of Pharmaceutical Scientists (AAPS)
Parenteral Drug Association (PDA)
European Compliance Academy (ECA)
European QP Association (QPA)
Deutsche Gesellschaft für Regulatory Affairs (DGRA)
Industrial Pharmacy Section of the International Pharmaceutical Federation (FIP)
For more details please refer to the following PDF files:
