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JSS College of Pharmacy, Mysore

Roles & Responsibilities of Sponsors, Institution and Monitor in Safety Monitoring in Clinical Trials

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Department of Pharmacy Practice in association with Pharmacy Education Unit (PEU) of JSS College of Pharmacy, Mysuru organized a Guest Lecture on ‘Roles & Responsibilities of Sponsors, Institution and Monitor in Safety Monitoring in Clinical Trials’ on 28th February 2019 at Seminar Hall, Department of Pharmacy Practice, JSS College of Pharmacy, Mysuru. Dr. Raj Kumar, Project Manager, Site Management & Monitoring (SMM) - Asia, AstraZeneca Pharma India Ltd., Bangalore was the speaker. The objective of this lecture was to make the students understand about the regulations on management of medication safety issues during clinical trials. During this lecture, Dr. Raj Kumar explained about Serious Adverse Events (SAE), and their reporting requirements & timelines in India and abroad. He also explained about the importance of clinical trials, and evolution of clinical trial related ethics & regulations. At the end of his presentation, Dr. Raj Kumar briefed about prospective employers, and career path & opportunities in clinical operations, and data management. Department of Pharmacy Practice in association with Pharmacy Education Unit (PEU) of JSS College of Pharmacy, Mysuru organized a Guest Lecture on ‘Roles & Responsibilities of Sponsors, Institution and Monitor in Safety Monitoring in Clinical Trials’ on 28th February 2019 at Seminar Hall, Department of Pharmacy Practice, JSS College of Pharmacy, Mysuru. Dr. Raj Kumar, Project Manager, Site Management & Monitoring (SMM) - Asia, AstraZeneca Pharma India Ltd., Bangalore was the speaker. The objective of this lecture was to make the students understand about the regulations on management of medication safety issues during clinical trials. During this lecture, Dr. Raj Kumar explained about Serious Adverse Events (SAE), and their reporting requirements & timelines in India and abroad. He also explained about the importance of clinical trials, and evolution of clinical trial related ethics & regulations. At the end of his presentation, Dr. Raj Kumar briefed about prospective employers, and career path & opportunities in clinical operations, and data management.

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