Pharmacovigilance: Focus or skills

This two-day programme will give you a comprehensive review of signal detection and regulatory expectations including the new updated Signal Module IX and Eudravigilance quantitative signal requirement.

This course provides a practical guide to both producing and maintaining the PSMF to ensure compliance and has been fully revised to include the latest updates.

Understand the relationship between RMPs and safety reviews; PBRERs/DSURs; licence submissions (CTD) and their maintenance.

In this exciting new course, gain an introduction into the transformative impact of artificial intelligence on drug safety and monitoring.

Delve into the world of additional Risk Minimization Measures (aRMMs) and explore everything from the regulatory framework surrounding aRMMs to their impact on patient safety and healthcare outcomes.

A comprehensive comparison between the importance Risk Evaluation and Mitigation Strategies (REMS) and Risk Management Plans (RMP) in drug safety.

This two-day course covers international standards for clinical and post-marketing drug safety, including ICH guidelines, adverse event reporting, signal detection, and risk management strategies.

This two-day course offers a thorough understanding of literature searching in drug safety, covering regulatory requirements, search criteria, and the interpretation of safety data, while also providing practical assessments to apply knowledge to real-world pharmacovigilance cases.

A comprehensive introductory guide to signal detection in pharmacovigilance, covering its history, regulations, processes, and safety assessments.