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ISPE Singapore Affiliate Conference & Exhibition
23 - 25 August 2023
Times are shown in your local time zone GMT
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Dr Ganapathy Mohan

Executive Director, External Advocacy and Strategies & ICH Q13 EWG - Merck & Co

Professional Bio

Ganapathy leads the Global External Advocacy and strategies for Global Quality and Compliance. Prior to this until 2017, he was Head of Small Molecule Development Quality, responsible for ensuring GMP compliance and release of all materials and investigational Medicinal Products for use in clinical trials. Ganapathy was Head of Global CMC regulatory Affairs until 2015. Prior to joining Merck, he was Associate VP of Global Analytical Sciences at Sanofi Aventis, where he worked for 23 years.

With his Ph. D in Analytical Chemistry from Kansas State University, Ganapathy’s area of interests are in separation sciences, application of PAT and science driven risk-based approaches towards global registrations of pharmaceuticals and biologics. He is Past Chair of the AAPS Regulatory Sciences Section, board member of PQRI and has served in the Council of Experts for the United States Pharmacopeia. Ganapathy currently represents Merck in APIC, the PhRMA GQMWG and is the PhRMA Lead on the ICH Q13 Continuous Manufacturing Guidance Development Expert Working Group. He leads the PhRMA Task force on Nitrosamines and is Vice-chair of the Quality Coordinating Committee of IQ Consortium.