USFDA–CDSCO-DIA: “Workshop on Global Anti-Infective Drug Development: Challenges and Opportunities”
- National Chair Clinical Pharmacology
- ICMR, India
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.
Edward M. Cox, MD, MPH
- Vice President, Regulatory Affairs
- Regeneron, United States
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.
Sumathi Nambiar, MD, MPH
- Senior Director, Child Health and Innovation Leadership Department
- Johnson & Johnson, United States
- Head, Medical and Regulatory Affairs
- Syngene International, India
- Deputy Drugs Controller
- CDSCO West Zone, India
- Medical Product Safety Coordinator
- FDA, India
Dr. Sudheendra is the Medical Product Safety Coordinator for BIMO and Medical Devices. Prior to joining USFDA India office, Sudheendra worked for a leading Contract Research Organization in India as Head – Quality Assurance [GCP]. He has about 18 years of experience in Clinical Research, Quality Assurance, and Quality Management Systems. He has audited more than 500+ Bioequivalence Studies and conducted site audits of different therapeutic drugs that were involved in conducting BEQ studies in Patients, Phase I to Phase III Clinical Trials in patients. He also is experienced in hosting inspections for different regulatory agencies such as USFDA, EMA, ANIVSA, Malaysia, Thailand.
- International Relations Specialist
- U.S. Food and Drug Administration, India
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.
- Senior Scientist
- ICMR, India
- Mission Director -PMU National Biopharma Mission
- BIRAC, India
- Principal Consultant & CEO
- Arkus Research, India
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.
- Co-Founder & Director
- Bugworks Research India Pvt. Ltd., India
- Director Drug Discovery Research
- Wockhardt , India
- Accreditation & Quality Systmes Incharge
- Apollo Research & Innovations (ARI), India
- Director in Charge
- National Institute for Research in Tuberculosis, India