Advanced Pharmacovigilance: From Performing Successful Due Diligence to Benefit-Risk Assessments – What to Consider Training Course

This advanced course provides a comprehensive and practical exploration of modern pharmacovigilance, designed for professionals with existing experience in drug safety who need to navigate an increasingly complex regulatory landscape. As expectations continue to evolve, organisations must manage a broad range of safety, compliance, and risk assessment activities to remain inspection-ready and protect patient safety.

The training delivers a detailed understanding of how a compliant pharmacovigilance system operates in practice, covering key areas such as audit readiness, quality management, and regulatory expectations. Participants will explore how safety data is reviewed and interpreted across the product lifecycle, including both clinical development and post-marketing phases, with a strong focus on signal detection, product safety reviews, and effective decision-making.

The course also examines critical regulatory deliverables and processes, including the Pharmacovigilance System Master File (PSMF), periodic safety reporting, core safety information development, and risk management planning. It provides insight into how pharmacovigilance obligations are managed within licensing agreements and global clinical trials, alongside the challenges of ensuring consistent compliance across multiple regions.

With a strong emphasis on real-world application, the programme incorporates interactive exercises and case-based learning to reinforce key concepts. Participants will develop the skills needed to assess risk–benefit profiles, respond to emerging safety issues, and manage crisis situations effectively, including communication with regulators and internal stakeholders.

By the end of the course, attendees will have the knowledge and confidence to manage complex pharmacovigilance responsibilities, support regulatory compliance, and contribute to robust, inspection-ready safety systems within their organisation.