Princeton, 11 April 2019:
26 delegates from 14 companies convened at pvindia for the 7th forum on Pharmacovigilance (PV) in Mumbai on March 6th. Throughout the day there was good and lively participation with a high level of engagement and interaction.
Key areas of interest for the participating companies included Safety Data Exchange Agreements, Pharmacovigilance System Master File, Brexit, PV Process Services, and PV Technology. Key priorities include Brexit readiness, PSMF readiness, SDEA process and technology, as well as PV automation.
The attendees learned about the latest global regulatory perspectives – post Brexit regulations of MHRA, EMA’s HQ movement to Amsterdam causing delays in response times, Mexico posing challenges with respect to RMP/RMA, new ROW authorities like Oman tightening their regulations, Ukraine trying to adapt EU standards, challenges associated with importing EVDAS data, and so on.
A session on ‘PV Today – Moving towards operational excellence’ comprised of a presentation by Bristol Labs on ‘Planning to be PSMF ready’ followed by a panel discussion lead by Piramal and Advanz Pharma - the session addressed the planning and managing of safety database upgrades including IDMP compliance, PSMF readiness, and saw time set aside for a roundtable discussion to share and build best practice on Safety Data Exchange Agreements and compliance with global regulations.
The day concluded with a session exploring the PV Vision 2025 – continuing the forward looking journey, led by an introduction from Navitas on trends in PV automation, followed by a member presentation by Novo Nordisk on Robotic Process Automation resulting in a discussion to explore how safety systems can be effectively augmented to improve process efficiencies.
Full details will be shared in the forum outputs to the group.