Oviya MedSafe to host webinar on pharmacovigilance system for regulatory compliance in India

Oviya MedSafe, a pharmacovigilance consulting and drug safety services organisation, has announced a complimentary educational webinar titled “How to Build a Pharmacovigilance System for Regulatory Compliance in India” on 10 September 2026 from 11:00 AM to 1:00 PM IST.

The webinar comes following regulatory attention to pharmacovigilance in India. On 3 June 2026, the Central Drugs Standard Control Organisation (CDSCO) issued a circular reiterating the requirement under Paragraph 6.11 of Schedule M for licensees to maintain a pharmacovigilance system for collecting, processing and forwarding adverse drug reaction reports associated with drugs manufactured or marketed by the licensee.

The circular further directed stakeholders to ensure the establishment and maintenance of an effective pharmacovigilance system in compliance with the applicable provisions of the Drugs & Cosmetics Act, 1940, the Rules made thereunder, and the New Drugs and Clinical Trials (NDCT) Rules, 2019. It also noted that compliance may be verified during routine inspections and other regulatory activities.

Against this backdrop, pharmaceutical and biotechnology companies are evaluating whether their existing arrangements support their regulatory responsibilities and whether their pharmacovigilance systems are sufficiently robust, sustainable and inspection-ready.

The session will be led by Dr J Vijay Venkatraman, Managing Director & CEO, Oviya MedSafe Pvt Ltd, who has 25 years of experience spanning clinical medicine, pharmacovigilance, drug safety, regulatory compliance and pharmacovigilance system development.

Speaking about the initiative, Dr Vijay said; “A pharmacovigilance system is no longer simply a compliance requirement. It is an essential component of patient safety and responsible product stewardship. Many organisations understand the need for pharmacovigilance but are less certain about what constitutes a complete and sustainable system. Through this webinar, we hope to provide practical guidance that will help pharmaceutical and biotechnology companies better understand the key elements of an effective pharmacovigilance framework and their regulatory responsibilities as Marketing Authorisation Holders.”

The webinar will provide insights into establishing and maintaining an effective pharmacovigilance system, with emphasis on the expectations applicable to pharmaceutical and biotechnology companies manufacturing and/or marketing products in India.

Topics will include organisational, governance, procedural, quality and system elements that need to be considered when establishing a pharmacovigilance framework. The session will also cover approaches to building a system that can evolve with an organisation’s growth, business needs and regulatory obligations.

Participation is free of charge and restricted to representatives of pharmaceutical and biotechnology companies manufacturing and/or marketing products in India. Registrations will be reviewed prior to approval, with participation limited to 100 participants.

Webinar details

Title: How to Build a Pharmacovigilance System for Regulatory Compliance in India
Date: Thursday, 10 September 2026
Time: 11:00 AM to 1:00 PM IST
Platform: Microsoft Teams Webinar
Speaker: Dr J Vijay Venkatraman, Managing Director & CEO, Oviya MedSafe Pvt Ltd

Registration

Interested participants may submit a registration request through the registration form.

https://forms.cloud.microsoft/r/Pb0htB8dM8

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