Pharma IQ Members


Manuel Zahn

For almost 12 years, Dr. Zahn has been involved in International Conference for Harmonisation (ICH) Quality topics, starting as European pharmaceutical industry (EFPIA) topic leader ‘Stability’ in 1991. He has been a member of the ICH Expert Working Group developing the ICH Stability Guidelines until 2003. As EFPIA co-topic leader from 1997 to 2001, he contributed to the development of the ICH Common Technical Document (CTD) Guideline M4-Q.

From 2001 to 2005 Dr. Zahn represented the international pharmaceutical manufacturers (IFPMA) when the Association of the Southeast Asian Nations (ASEAN) Stability Guideline has been developed.

As a World Health Organization (WHO) Temporary Advisor, he has been involved in developing a regional stability guideline for the WHO Eastern Mediterranean Region as of 1993. A revised version of the guideline has been released in 2006. This document was then used as a draft for the new global WHO Stability Guideline released in 2009.

Dr. Zahn supported the innovative Process Analytical Technology / Real Time Release (PAT / RTR) concept in discussions with the EMEA Quality regulators and inspectors. He took over the regulatory lead for a PAT/RTR project in 2006, and managed the submission of the first pilot product for PAT/RTR using the pilot EU Worksharing Procedure, and achieved a positive decision in 2007.

Dr. Zahn is a member of the Steering Committee of the American Association of Pharmaceutical Scientists (AAPS) Stability Focus Group.

Over 30 papers in journals and textbooks have been published since 1978, and presentations delivered at many international conferences and training courses since 1988. Since 1998, Dr. Zahn is an active member of the Editorial Board of ”The Regulatory Affairs Journal – PHARMA”.