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JSS College of Pharmacy, Mysore

New Regulation for Clinical Research in India

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Department of Pharmacy Practice in association with Pharmacy Education Unit (PEU) of JSS College of Pharmacy, Mysuru organised a Guest Lecture on ‘New Regulation for Clinical Research in India’ on 12th October 2018 at Lecture Hall - 2, JSS Hospital, Mysuru. Mr. Shambho Ghosh, Senior Executive Clinical Affairs and Pharmacovigilance, Biological E Ltd., Hyderabad was the speaker. The objective of this lecture was to make the participants understand the recent update on the regulations for conducting clinical research in India. During his lecture, Mr. Shambho briefed the audience on newer regulation for clinical research and highlighted the regulatory update on reporting serious adverse events (SAE) while conducting clinical trials and also the compensation calculation procedure adopted by subject expert committee in the regulatory agency. He then asked the students to calculate the compensation for an SAE after giving the details of an SAE. Participants appreciated the efforts of Mr. Shambho in making them understand the topic by giving a practical exercise. Staff and students (Vth & VIth year Pharm.D and PG Diploma in Clinical Research) of Department of Pharmacy Practice attended the guest lecture. At the end of the session, participants got an opportunity to interact with the speaker and clarify their doubts.

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