ADR Archives - European Industrial Pharmacists Group (EIPG)

A new member within EIPG


The European Industrial Pharmacists Group (EIPG) is pleased to announce the Romanian Association (AFFI) as its newest member following the annual General Assembly of EIPG in Rome (20th-21st April 2024). Commenting on the continued growth of EIPG’s membership, EIPG President Read more

The EU Parliament voted its position on the Unitary SPC


by Giuliana Miglierini The intersecting pathways of revision of the pharmaceutical and intellectual property legislations recently marked the adoption of the EU Parliament’s position on the new unitary Supplementary Protection Certificate (SPC) system, parallel to the recast of the current Read more

Reform of pharma legislation: the debate on regulatory data protection


by Giuliana Miglierini As the definition of the final contents of many new pieces of the overall revision of the pharmaceutical legislation is approaching, many voices commented the possible impact the new scheme for regulatory data protection (RDP) may have Read more

Webinar: Pharmacovigilance as a specialization and the role of the Pharmacovigilance Risk Assessment Committee (PRAC)

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EIPG webinar

Next EIPG webinar is to be held on Wednesday 31st of May 2023 at 17.00 CEST (16.00 BST) in conjunction with PIER and University College Cork. Sofia Trantza, a pharmacist with long experience as a Qualified Person for Pharmacovigilance in the Pharmaceutical Industry, currently representing Greece at the European Medicines Agency (EMA) as a member of the Pharmacovigilance Risk Assessment Committee (PRAC) will present the role and the procedures of the latter as a European body responsible for providing recommendations to EMA on any questions relating to pharmacovigilance activities in respect of medicinal products for human use.

According to the World Health Organization (WHO) pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. During the pandemic, this science went more popular than ever, and many people got familiarized with it. A very important role at the activities of this speciliazation plays the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA).

Webinar attendees will gain understanding of:

  1. What is pharmacovigilance and what it represents for the public health.
  2. The process of reporting adverse reactions at national and at European level.
  3. The main activities and procedures in this discipline.
  4. The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA).
  5. The role and the responsibilities of PRAC Committee.
  6. The processes that PRAC is engaged in and how the work of this Committee is reflected in these processes.

This is an event for members of EIPG member organisations. Contact your national association EIPG representative for further information.