MOHAN GANAPATHY

Head, Global Quality and Compliance, Merck & Company, USA

Ganapathy Mohan leads the Global External Advocacy and strategies for Global Quality and Compliance. Prior to this until April 2017, he was the head of Small Molecule Development Quality, which is responsible for ensuring GMP compliance and release of all materials and investigational Medicinal Products for use in clinical trials.

Mohan was the head of Global CMC regulatory Affairs at Merck until April 2015.  Prior to joining Merck, he was Associate VP of Global Analytical Sciences at Sanofi and was there for 23 years.

Mohan has a Ph. D in Analytical Chemistry from Kansas State University and his area of interests are in separation sciences, application of PAT and science driven risk-based approaches towards global registrations of pharmaceuticals and biologics.

Mohan was 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 till 2015. He currently represents Merck in the PhRMA GQMWG and is the PhRMA Lead on the ICH Q13 Continuous Manufacturing Guidance Development Expert Working Group. Mohan leads the PhRMA Task force on Nitrosamines. He also serves as the Vice-chair of the Quality Coordinating Committee of IQ Consortium and represents Merck in APIC.

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23 September 2021

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