Ensuring Effective Pharmacovigilance Regulatory Intelligence With FSP Partnerships

Pharmacovigilance (PV) is a crucial aspect of drug and medical device development and commercialization, and effective PV regulatory intelligence (RI) ensures that PV is conducted accurately and cost-effectively. PV RI involves tracking the publication of new and updated PV-relevant regulations and regulatory guidance. Although this concept appears straightforward, in practice, it can be highly complex, and inadequate management can have serious consequences. Failure to keep up with regulatory changes can significantly impact sponsors, marketing authorization holders, healthcare professionals, and consumers.

To manage these challenges, many pharmaceutical, biotech, and medical device companies rely on functional service provider (FSP) partnerships for comprehensive and cost-effective PV RI. Engaging with the right FSP PV partner is crucial in this high-stakes environment.

This webinar will explore key PV RI capabilities that distinguish top-tier FSP PV partners from other service providers, including monitoring regulation changes, analyzing and interpreting regulations and guidance, communicating regulatory requirements, operationalizing change, and guiding the development of new and updated regulations and guidance.

By watching the presentation below, viewers will learn what it takes to stay abreast of constantly changing regulatory requirements, discover tools that capture a wide range of country-specific PV regulations and procedural guidance, and understand how effective PV RI delivers real value through the analysis and interpretation of how regulations and associated guidance need to be applied in real-world operations. Additionally, they will gain insights into what to look for in a dedicated FSP PV partner who can provide solid regulatory expertise and effective safety reporting across pharmaceutical, biotech, and medical device development.