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SELECTBIO Conferences Quality, Compliance & Audit in Clinical Trials

Mita Nandy's Biography

Mita Nandy, Consultant, Central Drugs Standard Control Organization

Dr Nandy has over 22 years of experience in the pharma industry and 4 years in CDSCO-INDIA as consultant New Drugs reporting to the Drugs controller general of India. Mostly involved in pharmacovigilance of new drugs and old drugs,SAE causality assessment and compensation determination; inspection of CRO’s,hospitals and pharma company’s for determination of ethical conduct of clinical studies and GCP and making of pharmacovigilance related SOP .
She pursued her MD pharmacology from Sambalpur University, Orissa-India
She has been instrumental in setting up Medical division in 2 pharmaceutical companies – MODI Mundi pharma and LG Lifesciences India and also converting service dept. to revenue generating dept. Dr Nandy has approximate 18 years of training experience on drugs, devices (7 years) and clinical trial management to research associates, medical specialists India and abroad. Extensive experience of more than 15 years in conducting clinical trials Phase I to Phase III and BA/BE studies on old and new drugs and devices. She Conducted vaccine studies for WHO prequalification in 1241 infants and obtained WHO prequalification for the tetravalent study. Conducted phase III clinical trials for global submissions. Extensive experience in getting new drug approvals and defending projects in meetings with the NEW DRUG ADVISORY COMMITTEE of DCGI. She is also a Key member of PHD Chambers (as a Regulatory head of team of regulatory personnel of the multinationals to represent regulatory issues with the govt.), OPPI & ASSOCHAM. She has One year working experience in HQ-Korea on pharmaco-vigilance, clinical trial, new product management and strategy development for new product from (April-08 to March-09) and COO Fortis clinical research-1 year-CRO. Presently Dr Nandy is a consultant to DCGI on New drugs-Key operational areas being overviewing clinical research related documents, check for GCP compliance of the ongoing studies in the country, member of the expert committee to evaluate trial related SAE’s, and advisor to the Pharmacovigilance program of the country. Member of The Drug Safety Executive Council (DSEC), US. She has teaching experience: Total four and half yrs of Teaching of undergraduate and post graduate medical students.

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Regulatory Amendments and SAE Reporting with respect to CT and BE Studies

Thursday, 12 April 2018 at 11:20

Add to Calendar ▼2018-04-12 11:20:002018-04-12 12:20:00Europe/LondonRegulatory Amendments and SAE Reporting with respect to CT and BE StudiesQuality, Compliance and Audit in Clinical Trials in

Add to Calendar ▼2018-04-12 00:00:002018-04-13 00:00:00Europe/LondonQuality, Compliance and Audit in Clinical TrialsQuality, Compliance and Audit in Clinical Trials in