Capacity building in India

The MRCT Center at Harvard continues its active engagement in India. Most recently, important efforts to address regulatory issues  have been expanded to develop tools and capacity in causality assessment of adverse events that occur during participation in clinical trials.

In February 2015, MRCT Center Faculty Co-Director Dr. Barbara Bierer represented the MRCT Center at the Bangalore India Bio Conference in Bangaluru (formerly Bangalore, the capital of the Indian state of Karnataka) participating in a dynamic discussion of “Addressing Clinical Trials Complexities in India.” The conference brought together over 400 registrants, including investigators, industry representatives, regulators, and students primarily from India and other Southeast Asian countries.

Dr Barbara Bierer and Shoibal Mukherjee also taught at a one-day workshop in Delhi, India, on 12 February 2015, sponsored by the MRCT Center at Harvard in collaboration with the Indian Society of Clinical Research (ISCR). The workshop focused on “Best Practices for Determining Causality Assessment for Adverse Events Occurring During Clinical Trial Participation.” The event was attended by over 25 clinical investigators, regulators, ethics committee members, clinical research professionals, industry members, and other professionals. This was the second one-day workshop addressing causality assessment in clinical trials that MRCT at Harvard has conducted in India.

At the 8th annual conference of the Indian Society for Clinical Research in Delhi, India, 13-14 February 2015, MRCT Center Faculty Co-Director Dr Barbara Bierer discussed “Hurdles to Achche Din for Patients of Tomorrow,” and participated in a panel on “Science and Health Technology Regulation in the Developing World.”