After a set of regulatory measures and Indian Supreme Court decisions in 2013 that imposed significant new restrictions and burdens on clinical research, the research enterprise in India has ground to a halt. What are India’s new clinical trial regulations and how will they impact clinical research in India that is sponsored or conducted by pharmaceutical and biotech companies, universities, medical schools and NGOs? Is there hope that some of these regulations will be refined in more workable ways? How will these regulations influence the future of clinical research in India and other countries? Please join the co-chairs of the Multi-Regional Clinical Trials Center (MRCT) at Harvard – Ropes & Gray Partner Mark Barnes and Dr. Barbara Bierer, SVP for Research at Brigham and Women’s Hospital – as they discuss the current regulatory situation affecting clinical research in India and broader lessons for clinical trials in emerging economies.
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