Webinar on How to develop a positive culture of Adverse Event Reporting

by Pharmaceutical Industries/Marketing Authorization Holders?”organized on

29 April, 2021



29 04 211

Participants of theWebinar on “How to develop a Positive Culture of Adverse Event Reporting by Pharmaceutical Industries/Marketing Authorization Holders?”

The Indian Pharmacopoeia Commission (IPC), Ministry of Health & Family Welfare, Government of India organized the Webinar onHow to develop a Positive Culture of Adverse Event Reportingby Pharmaceutical Industries/Marketing Authorization Holders?”on April29, 2021. The workshop was inaugurated by Dr. Rajeev Singh Raghuvanshi, Secretary-cum-Scientific Director, IPC and Dr. Jai Prakash, Senior Principal Scientific Officer and Officer-in-Charge, PvPI, IPC. Ms Rubina Bose, Deputy Drugs Controller (I), CDSCO, WZ; in her special remark emphasized on the contribution of PvPI to medicines safety and threw light on regulatory aspects of pharmacovigilance in pharmaceutical industry. Mr. Rishi Kumar, Ms. Swati Thapliyal and Mr. Omkar Mishra from NCC PvPI supported during the workshop. 


The workshop was tailored to regional needs and addressed challenges unique to Pharmacovigilance (PV) and its setup in Pharmaceutical industries. The workshop also addressed Industry e-reporting and its connection to VigiFlow and how the PV system can be effectively implemented by the MAHs in Pharmaceutical Industries. It also made them aware about the PV Guidance Document with the major focus on submission of E2B XML ADR related files to PvPI. Total 54 participants from different pharmaceutical industries and Academic institutes participated in this workshop.


In the technical session Dr.Salvador Alvarado Lopez, Pharmacovigilance Officer, Uppsala Monitoring Centre, Sweden explained the current working procedure of WHO-UMC and how WHO supports the national regulatory authorities of the member countries by providing their stakeholders easy access to VigiFlow & Vigibase. He also threw some light on WHO current pilot project of e-reporting of Adverse events (AEs) by Pharmaceutical Industries. Dr.Vivek Ahuja, Vice President - Medical Affairs & Head Global Pharmacovigilance, Sun Pharma India, in his presentation explained about the different barriers for AE reporting by Healthcare professionals and Pharmaceutical Industries & how to overcome these barriers. He also suggested that it is a matter of, how do we inculcate positive behavioral changes towards the AE reporting among the professionals involved in supply chain management of medicines like manufacturers, importers, distributors, etc. He emphasized that we need to give personal motivation, use deliberate practice, and implement regulatory obligation to change the environment. The MAHs assured that they would effectively implement the PV system and train their colleagues in their organization.


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