DIA/MEB Excellence in Pharmacovigilance: GVP Modules I to XVI
Organized and delivered in collaboration with the Dutch Medicines Evaluation Board (MEB), this face-to-face training course covers the major pharmacovigilance processes as outlined in GVP I to XVI. It is designed to provide a strong foundation in all key aspects of European Post-Marketing Safety regulatory requirements.
Furthermore, it includes highlights and updates on the pharmacovigilance legislation as well as the latest news on the ICH activities in pharmacovigilance.
This training course will take place in Amsterdam, allowing live interaction and real-time Q&A with the large panel of renowned experts onsite. We have also decided to make this course available for virtual participation (please see the links below), with some limitation regarding interaction with fellow participants and faculty members. You can register for your preferred format immediately and without concern: DIA will monitor the situation and keep all registrants informed on a regular basis.
- Post-Marketing: GVP Modules VI and VII
- Regulatory Aspects in the PV: GVP Modules I, II, III and IV
- Risk Management: GVP Modules V, VIII, XV and XVI
- Signal Management: GVP Modules IX and X
Who should attend?
Professionals with experience in safety related activities of the drug development process and/or those with a need of a holistic overview about all PV related regulatory requirements will benefit most, such as:
- Pharmacovigilance Officers, Managers, Specialists, Experts, or Coordinators
- Regulatory Compliance, Quality or Safety departments Heads, Directors or Managers
- Understand key definitions and methods in pharmacovigilance
- Describe the expedited and periodic ICSR reporting requirements in post-marketing
- Understand the process of audits and inspections in pharmacovigilance
- Understand the principles of signal management
- Describe the components of risk management in pharmacovigilance
Wendy Huisman, PharmD • Director
Fakhredin Sayed Tabatabaei, MD, PhD • Senior Assessor