Dr Kshirsagar was former acting Vice-Chancellor at the State Health Science University, and also Dean Director of medical education and research, and Prof. Head Clinical Pharmacology G.S. Medical College KEM hospital, Parel, Mumbai and at T. N. Medical College Mumbai, President of the Indian Pharmacology Society and Infectious Disease Society, India, Chairman Academic Committee AIIMS. Govt. of India, Delhi.She has won many awards besides being an University topper, gold medalist, B.C. Roy National Award, Vasvik Award for industrial research, developing and patenting liposomal drug delivery system, Mayor’s award three times.

I am currently Vice President, Regulatory Affairs, at Regeneron Pharmaceuticals in Tarrytown, NY. I am trained in internal medicine and infectious diseases. I have over 20 years of experience at the US FDA, including 12 years as the Director of the Office of Antimicrobial Products, an Office of approximately 150 people.

Dr. Sudheendra is the Senior Technical Advisor for drugs. Prior to joining FDA India Office, Sudheendra worked for a Contract Research Organization as Head – Quality Assurance [GCP]. Sudheendra has about 20 years of experience in Clinical Research, Quality Assurance, and Quality Management Systems. He has audited more than 450 Bioequivalence Studies and audits of different therapeutic drugs. He also has exposure to different regulatory agencies. Sudheendra holds a Ph.D. in Biochemistry from Gulbarga University, Karnataka.

Ms. Kristan Callahan is an international relations specialist in the India Office of the USFDA, Office of Global Policy and Strategy, focusing her work on medical products and bioresearch monitoring. Prior to this role, she worked as a public health advisor in the Office of Trade, Mutual Recognition, and International Arrangements. She started in OGPS in 2018. Prior to joining OGPS, Kristan served as a lead regulatory counsel in the Center for Drug Evaluation and Research. While there, she advised CDER’s Office of Management, Division of User Fee Management and Budget Formulation staff on matters related to the user fee amendments involving biosimilar biological products, brand name and generic drug products, and compounding pharmacies.

A Clinician and Researcher, Dr Anupama Ramkumar is the principal consultant and CEO of Arkus Research Pvt. Ltd, a clinical consulting company engaged with pharmaceutical companies and CROs worldwide.With over 26 years of medical experience and 22 years of experience in Clinical Research Industry she bridges the field of medicine and pharmacology effectively and is a sought after clinical development and GCP expert as well as technical strategy advisor for pharma companies and research units. Her forte lies in demystifying GCP to build practical and effective Quality management systems for regulated drug development with a focus on compliance and operational excellence.