According to NIH, the number of clinical trials under way in India has risen from 50 in 2002 to 560 today, a total that does not include non-U.S. IND studies or investigator-initiated research. The growth of trials in India is increasing at an exponential rate and could soon be expanding 100 percent a year.
That’s no accident. A clinical trial registry has been launched in India, and the government looks favorably on international clinical trials. Better infrastructure, an improved regulatory environment and a growing number of experienced researchers have caught the attention of sponsors looking to reduce drug development timelines and costs.
However, just like many other markets, a number of complexities still exist. Specifics in the regulatory guidelines, combined with regional and cultural intricacies, make it crucial to do your homework first.
International clinical research experts Dan McDonald and Vijai Kumar detail India’s regulatory environment today and where it’s headed. Plus they’ll explain how to submit studies to regulatory bodies either with or without third party assistance.
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This audio CD/Transcript examines specific details regarding the regulatory guidelines that exist today and where regulations are going. Plus, it covers specific case studies including success stories and potential pitfalls.
This audio CD/Transcript is a must for members of biopharmaceutical firms and contract research organizations looking to conduct trials in India, including:
Dan McDonald is vice president for business strategy in the Boston office of Excel Life Sciences (ELS) where he draws on his depth of industry experience to connect sites with sponsors and help biopharmaceutical companies develop effective patient recruitment and site-selection strategies. Dan joined ELS after serving as senior vice president for strategic development for D. Anderson & Company, a leading provider of global patient recruitment and retention services. Prior to that, he was general manager for Thomson CenterWatch, with organizational responsibility for Thomson NEIRB, an independent institutional review board, and he was responsible for oversight of the development and publication of articles and strategic planning reports focused on the rapid growth of clinical research in emerging markets in India, China and Central and Eastern Europe.
Vijai Kumar, M.D. is president and chief medical officer for the Boston office of ELS, where he is responsible for starting the concept of site management organizations in Asia. Vigai has over 34 years of experience as a clinician, investigator, pharmaceutical physician, consultant and service provider and has served as a member of the expert committee constituted by the Drugs Controller General India to develop GCP guidelines in India and as a member of the Board of Governors for the Institute of Clinical Research, India. He has personally been involved in conducting more than 200 clinical trials in various therapeutic areas such as, infectious disease, neuropsychiatry, cardiovascular disorders, metabolism and rheumatology in Asia, Europe and the U.S. Prior to joining ELS, he served as first president and CEO of Neeman Medical International, as medical director for Sandoz and as regional director, Asia, for the Upjohn Company.
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