Friday, 28 July 2017 - Hyderabad, India
Official language: English
Pharmacovigilance is a domain that involves a variety of stakeholders such as pharmaceutical manufacturers, drug marketers, contract research organizations, regulators, healthcare professionals, subject matter experts and the consumers, among others. India is globally recognized as an important hub for generic drug manufacturing and the Indian pharmaceutical industry has carved a niche for itself in exporting its products to many developed as well as emerging countries. Of late, India is also being seen as a target destination for procurement of support services required for the global pharmaceutical industry, with pharmacovigilance outsourcing having grown to an impressive extent in the past decade. Simultaneously, newer developments in Indian Pharmacovigilance have occurred which include a requirement for XML-E2B format reporting of ICSRs by the pharmaceutical industry to the Pharmacovigilance Programme of India (PvPI) and the release of the March 8th 2016 dated gazette notification GSR 287 (E) legally mandating pharmacovigilance for all pharmaceutical companies. With news of the revised draft of the ‘Pharmacovigilance Guidelines for Marketing Authorization Holders of Pharmaceutical Products in India’ being close to finalization by the Indian regulatory authorities, understanding pharmacovigilance is now a compelling need for all the stakeholders in India.
At this ripe moment, the task of integrating and streamlining the opinions and expectations of all stakeholders of Indian pharmacovigilance assumes significant relevance. The Indian Pharmacovigilance Day 2017 conference is all set to achieve this formidable goal with immense focus and dedication. During the conference, expert speakers from the industry, health authorities, research bodies, academia and healthcare delivery centres will share their perspectives on the multifaceted outlook of the discipline of pharmacovigilance in India and deliberate on the challenges they expect to face in 2017, with the topics of focus ranging from the role of automation in drug safety, causality assessment in clinical trials, pharmacovigilance regulations in emerging countries, vaccine safety, safety of biosimilars, the role of medical writing in pharmacovigilance, excellence in drug safety operations and last but not the least, a colloquium on the pros and cons of pharmacovigilance outsourcing.
Dr J Vijay Venkatraman - Managing Director & CEO at Oviya MedSafe
This one-day conference is designed to benefit functional/technical professionals working in the pharmacovigilance/regulatory/medical affairs/marketing domains in organizations involved in pharmaceutical manufacturing/drug marketing/contract research, healthcare professionals in patient care, clinical investigators & research staff, academia and government health agencies, among others.