The Drug Information Associates (DIA) and the US Food and Drug Administration (FDA) will organise a 2-day multi-city workshop on 'Guidance and polices from the US FDA, European Medicines Agency (EMA) and Central Drugs Standard Control Organization (CDSCO)'. While the first workshop is held in Mumbai on May 3 and 4, 2018, the second will be held in Hyderabad on May 7 and 8 followed by Bengaluru on May 10 and 11.
The joint programme offers an opportunity to listen to expert regulators from the US FDA, EMA and CDSCO on the same platform in Mumbai, Hyderabad and Bengaluru. The two-day workshop will highlight on the Good Clinical Practices (GCP), biosimilars, etc. There will also be presentations on case studies and panel discussions, stated the organisers.
The key objective of the workshop is to disseminate regulatory agencies' current thinking and ascertain the industry viewpoint on key issues. It is also expected to promote active dialogues during the workshop where feedbacks will help the regulators and the industry to move forward.
The programme co-chair is Letitia Robinson, Country Director, India Office, US Food and Drug Administration and Ramakrishnan Sundaram, Director Regulatory Affairs, Abbot.
The programme committee is represented by Sam Haidar, Senior Science Advisor, CDER, Office of Study Integrity and Surveillance (OSIS), US FDA; Kristan Callahan, International Relations Specialist, BIMO and Medical Devices, India Office, US FDA; Jennifer Adams, Consumer Safety Officer, India Office, US FDA; Sudheendra Kulkarni, Medical Product Safety Coordinator, India Office, US FDA.
From Europe, there are Fergus Sweeney, Head, Inspections, Human Medicines Pharmacovigilance & Committees Division, European Medicines Agency and Sophia Mylona, Clinical and Non Clinical Compliance, Committees and Inspections Department, European Medicines Agency.
The representatives from India are K Bangarurajan, Joint Drugs Controller, CDSCO; Anirban Roy Chowdhury, Senior Director-Global Clinical Trial Operations, MSD Pharmaceuticals; Parisa Asvadi, VP - Regulatory Sciences, Aurobindo Pharma Ltd (Biologics Division); Ranjana Pathak, President – Global Quality, Medical Affairs & Pharmacovigilance, Cipla; Sonica Sachdeva Batra, Senior Director - Medical Sciences, Clinical Development, Dr. Reddy’s Laboratories; Subashri Shivkumar, Sr. Director and Head Clinical Development Services India and Sri Lanka, IQVIA and Vinu Jose, Associate Vice President, Head Clinical Development & Medical Affairs, Intas Pharmaceuticals Ltd. (Biopharma Division).