Indian Pharmacovigilance Day 2019

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. India has also established herself 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.

Meanwhile, a revolution, namely the release of the ‘Pharmacovigilance Guidance Document for Marketing Authorization Holders of Pharmaceutical Products’ (effective since January 2018), happened in the Indian pharmacovigilance requirements for the pharmaceutical industry, building upon the March 8th 2016 dated gazette notification GSR 287 (E) that made pharmacovigilance a legal mandate for the industry. In hot pursuit, the draft Pharmacovigilance System Inspection Guideline was also published by the Central Drugs Standard Control Organization (CDSCO) later in 2018 and is impending finalization following consideration of feedback from the industry. In addition, quite a lot of development has been seen in the clinical trial safety monitoring activity in India in recent times. Most importantly, the New Drugs and Clinical Trials Rules, 2019 came into force vide the publication of the March 19th 2019 dated gazette notification GSR 227 (E). Hence, it is obvious that understanding the reach and implications of Pharmacovigilance in India is inevitable now more than ever before for all stakeholders, especially manufacturers or importers of drugs.

At this juncture, the task of integrating and streamlining the opinions and expectations of all stakeholders of Indian pharmacovigilance continues to assume significant relevance, especially when interpretations vary. The Indian Pharmacovigilance Day 2019 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 2019.

Please click on the conference website https://indianpharmacovigilanceday2019.lsacademyevents.it/ for more information.