Excel Life Sciences invites you and your colleagues to view the included 45 minute web-based seminar on the regulatory policy for new clinical trials in India. Led by ELS executives with a combined 50+ years of clinical research and regulatory affairs experience in India, this short, hard-hitting session provides industry executives with a solid understanding of how to successfully navigate today's regulatory environment in India.
Specifically, the following topics will be addressed:
- Brief history of clinical research in India
- History of India's clinical research regulations
- Overview of recent regulatory changes
- Goals behind changes and ELS insights
- New structure of India regulatory agency
- New clinical trial submission/review process
- Current and anticipated review timelines
- Tips for correct submissions
- Review of potential risks, mistakes to avoid
About your presenters:
Dr. Vijai Kumar
President & CMO
Excel Life Sciences
Durham, NC
Dr. Vijai Kumar has over 40 years of experience in Global Drug Development and Regulatory Affairs. He is responsible for starting the concept of site management organizations in Asia. He has experience as a clinician, investigator, pharmaceutical physician, consultant and service provider. In addition, Dr. Kumar has served as a Member of the expert committee constituted by the Drugs Controller General (India) to develop GCP Guidelines and as a member of the Board of Governors for the Institute of Clinical Research, India. He has personally been involved in the conduct of over 200 clinical trials. He holds an M.D. in Internal Medicine and an M.B.B.S. from Armed Forces Medical College, Pune.
Mr. Aditya Vats
Regulatory Manager
Excel Life Sciences
Noida, India
Mr. Vats is a seasoned clinical research executive with strong experience managing the submission, support and defense of new clinical trials and clinical trial amendments in India. He is an expert on current regulatory policy and is a regular presence at the Ministry of Health, office of the Drugs Controller General -India located in New Delhi, India. He regularly interacts with key members at all levels of the regulatory submission and review process.
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