DIA in association with US FDA is organising a two-day multi-centre Good Clinical Practices (GCP) workshop in Mumbai and Hyderabad. While the Mumbai event will be held on May 12 and 13, 2017 at St Regis, the Hyderabad event will be held on May 15 and 16, 2017 at the Taj Krishna.
The workshop will highlight on guidance and policies from the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and Central Drugs Standard Control Organization (CDSCO).
The topics discussed at the workshop will include Data Integrity and BE Study. The participants will be able to interact with experts from USFDA, CDSCO, EMA and industry, who will share experiences and views of the global GCP environment, said the organisers.
The key features of the program cover Retrospect and Prospect of India GCP, overview of FDA’s Bioresearch Monitoring Program, EMA and National GCP Inspection: Systems and Procedures. It will also address on what an industry should expect during regulatory inspections and role of Ethics Committee in driving GCP compliance at trial sites.
Further the workshop will also deliberate on the USFDA’s focus on data integrity and the lessons learnt. It brings to the fore the triggers for inspections and selection of audits.
This apart, the discussions will also be held on GCP as a quality standard in clinical research. It will share inspection findings and a review of the recent regulatory actions. It will also help the participants to identify the ‘Root Cause Analysis: When Something Goes Wrong’. Besides it will mull over case studies and have a panel discussion.
The program will be chaired by Sean Kassim, Director, Office of Study Integrity and Surveillance, Office of Translational Science Center for Drug Evaluation and Research, USFDA along with Ramakrishnan Sundaram, Director Regulatory Affairs EPD, Abbott Healthcare.
The programme committee includes Leslie Ball, Assistant Commissioner of International Programs & Deputy Director, Office of International Programs (OIP) US FDA; Sam H. Haidar, Deputy Director, CDER, Office of Study Integrity and Surveillance (OSIS) Division of Generic Drug, Bioequivalence Evaluation, USFDA; and Solomon Yimam, assistant country director, USFDA India Office.
Laura Pioppo, scientific administrator, EMA Committees & Inspections Department, EMA; Angela Del Vecchio, EU Member State Representative, AIFA, Italian Medicine Agency; Ranga Chandrashekar, Deputy Drug Controller, CDSCO; Anirban Roy Chowdhury, Senior Director-Global Clinical Trial Operations, MSD Pharmaceuticals; Disha Dadke, AVP, Analytical Sciences, Biologics, Aurobindo Pharma; Gaurav Mathur, Director & Head, Regulatory Affairs, Clinical Development Services, Quintiles IMS; and Suresh Kankanwadi, Vice President, Dr. Reddy’s Laboratories are the other members of the committee.