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Regulatory and PV Working Groups Constructing the Road Ahead

Energizing start to the year, the DCVMN Regulatory and Pharmacovigilance Working Groups launched 2026 with a focused joint workshop in New Delhi during the third week of February. The workshop’s objective was for each working group to set clear and practical goals for 2026, and create a collaboration action plan with WHO SEARO aimed at addressing regulatory and safety needs for vaccine manufacturers in developing countries.

On day one, constructive discussions we held with Dr Adrien Inoubli and Dr Anil Kumar Chawla, framing how regional support and technical guidance can best align with manufacturers’ realities.

Across the two working groups, participants also dug into signal management, risk management and benefit–risk assessment tools, all viewed through the practical lens of manufacturers operating in resource constrained settings.

The workshop set the year’s priorities: identifying recurring challenges DCVMN members face with NRAs, translating those challenges into concrete working-group objectives for 2026, and beginning the work on a draft identification tool to underpin a reliance framework for regulatory and pharmacovigilance pathways in vaccine manufacturing. This is the kind of workshop that does more than talk, but kick-starts tangible, member-driven workstreams that will inform technical support, training, and advocacy throughout the year.

A thank you to the Working Groups’ chairs and co-chairs who steered these discussions: Mr Kumar Gaurav and Dr Manish Mahajan MD from the Regulatory Working Group, and Dr Patrícia Mouta Nunes de Oliveira for the Pharmacovigilance Working Group.

We will continue to translate these discussions into tools, training, and practical guidance so DCVMN members can navigate regulatory and safety pathways with more confidence and reliance-based options.