Good Pharmacovigilance Practice: Training on GVP Modules I and II

As part of the VISION Project, ACTG-CRO delivered two training sessions on Good Pharmacovigilance Practices (GVP), focusing on quality management systems and regulatory requirements for pharmacovigilance.

The sessions provided participants with an overview of the principles and operational requirements governing pharmacovigilance activities, with particular emphasis on GVP Module I and the Pharmacovigilance System Master File (PSMF).

Pharmacovigilance Quality Management Systems

The first session explored the fundamentals of Pharmacovigilance Quality Management Systems (QMS) and the requirements outlined in GVP Module I. Participants examined the role of quality management in pharmacovigilance, including the implementation of appropriate procedures, the definition of responsibilities and the importance of maintaining compliance with regulatory expectations.

The session highlighted how structured quality systems contribute to the consistent implementation of pharmacovigilance processes and support the continuous improvement of safety monitoring activities.

Understanding the Pharmacovigilance System Master File

The second session focused on the regulatory framework surrounding the Pharmacovigilance System Master File (PSMF). Participants explored the requirements for developing, maintaining and updating a compliant PSMF in line with applicable regulatory expectations and good practices.

Through practical examples and operational recommendations, the training addressed key considerations involved in documenting a pharmacovigilance system and ensuring that relevant information remains accurate, accessible and up to date.

The sessions were delivered by Roberto Molettieri and coordinated by Karim Khallout, PhD, CEO of ACTG-CRO.

By combining regulatory guidance with practical insights, the training helped participants strengthen their understanding of pharmacovigilance quality systems, compliance requirements and the operational practices needed to support effective safety monitoring.