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Holiday Inn Amsterdam - Arena Towers

Nov 14, 2023 9:00 AM - Nov 17, 2023 4:00 PM

Hoogoorddreef 66a, 1101 BE Amsterdam, Netherlands

DIA/MEB Excellence in Pharmacovigilance: GVP Modules I to XVI

This DIA/MEB face-to-face training course is designed to provide a strong foundation in all key aspects of European Post-Marketing Safety regulatory requirements.

Overview

Organized and delivered in collaboration with the Dutch Medicines Evaluation Board (MEB), this face-to-face interactive training course covers the major pharmacovigilance processes as outlined in GVP I to XVI at intermediate level. Other than lectures and exercises it gives a lot of room for interaction with the trainers and each other to ensure all your questions are answered. It is designed to strengthen your foundation in all key aspects of European Post-Marketing Safety regulatory requirements for marketed products as well as marketed products in clinical trials.
Furthermore, it includes highlights and updates on the pharmacovigilance legislation as well as the latest news on the ICH activities in pharmacovigilance.

 

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

Level: Intermediate

 

Learning objectives

At the end of this training course, participants will be able to:

  • Describe the expedited and periodic ICSR reporting requirements in development and post-marketing
  • Discuss the challenges regarding MedDRA and reporting special situations
  • Outline the required Quality Management System including PSMF, QPPV, audits and inspections in pharmacovigilance
  • List the principles of signal management
  • Describe the components of risk management in pharmacovigilance

 

Program Committee

  • Wendy Huisman, PharmD
    Wendy Huisman, PharmD Director
    Vigifit, Netherlands
  • Fakhredin Sayed Tabatabaei, MD, PhD
    Fakhredin Sayed Tabatabaei, MD, PhD Senior Assessor
    MEB, Netherlands

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