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Overview
DIA and US FDA will host a 2-day workshop on guidance and polices from the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and Central Drugs Standard Control Organization (CDSCO). GCP inspections related to the quality of clinical trials in Mumbai and Hyderabad. Additional topics discussed at the workshop will include, Data Integrity and BE Study. Interact with experts from USFDA, CDSCO, EMA and industry, who will share experiences and views of the global GCP environment.
Program Committee
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Sean Kassim, PhD Director, Office of Study Integrity and Surveillance, OTS, CDER
FDA, United States -
Ramakrishnan Sundaram Director, Regulatory Affairs
Abbott Healthcare, India -
Leslie Ball, MD Assistant Commissioner and Deputy Director, OIP, OC
FDA, United States -
Sam H Haidar, PhD, RPh Senior Science Advisor, CDER
USFDA, United States -
Jennifer Adams Assistant Country Director - India Office
USFDA India Office, India -
Laura Pioppo, MSc Scientific Administrator, CTIS expert
European Medicines Agency, Netherlands -
Angela Del Vecchio EU Member State Representative
AIFA - Italian Medicine Agency, Italy -
Ranga Chandrashekar Deputy Drug Controller
CDSCO, India -
Anirban Roy Chowdhury Director & Principal Consultant
ARC Life Science, India -
Disha Dadke AVP - Analytical Sciences Biologics
Aurobindo Pharma Ltd., India -
Gaurav Mathur Director & Head Regulatory Affairs
QuintilesIMS, India -
Suresh Kankanwadi Vice President
Dr. Reddy's Laboratories, India
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