Global Pharmacovigilance and Risk Management Strategies Conference

Ensuring global compliance in pharmacovigilance (PV) and risk management at local level can be challenging because of the dynamic and complex regulatory landscape across multiple regions. Key challenges faced by global companies may include, but are not limited to, setting up local PV processes, including a local responsible person, regulatory intelligence, and a review of local literature and risk minimization measures in multiple languages, to ensure global oversight over local processes. Patient safety can be achieved by creating a harmonized PV system globally, respecting regional divergence with local PV activities performed as part of the global PV system. This should include setting up effective project management to ensure governance and local oversight at global level.

A case study will be discussed wherein APCER supported a global pharmaceutical company with multiple acquisitions and a diverse portfolio of products across multiple regions in successfully setting up a local PV and risk management system, ensuring global compliance.