Pharmacovigilance in Clinical Trials

A European and DACH Perspective

• Understanding the fundamentals of pharmacovigilance and its role in clinical trials
• Overview of the regulatory framework in the DACH region including EU CTR and GDPR
• Practical responsibilities of sponsors, investigators, and CROs in safety data management
• Latest trends and quality assurance in pharmacovigilance including AI and digital tool

This interactive online seminar provides a practical introduction to pharmacovigilance (PV) in clinical trials, with a focus on regulatory requirements, stakeholder responsibilities, and safety processes in the DACH region.

Participants will gain a clear understanding of key PV concepts, including AE / SAE / SUSAR handling, safety reporting, data protection, and the roles of sponsors, investigators, and CROs. The training emphasizes realworld application through case examples, scenario-based discussions, and current challenges such as digitalization and AI in PV. By the end of the course, participants will be equipped to identify safety-relevant events, understand timelines and responsibilities, and navigate the PV landscape in early-phase clinical development. The seminar is ideal for professionals at all experience levels who are involved in drug safety activities within clinical trials.