Paul-Ehrlich-Institut

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Bulletin on Drug Safety – Current Issue 3/2024 Published

The Bulletin on Drug Safety is a cooperation between the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) and the Paul-Ehrlich-Institut (PEI). The quarterly publication provides information from both federal institutes on current aspects of the assessment of drugs. It focuses on pharmacovigilance – the continuous monitoring and evaluation of drug safety before and after marketing authorisation. The Bulletin includes articles on individual drugs as well as background information for understanding pharmacovigilance and research in this area.

The publication is available in German only.

Topics in the Current Issue

  • Editorial: MedSafetyWeek
  • Data on vaccine pharmacovigilance from 2022 and 2023
  • Preventing side effects: Contribution from the Drug Commission of the German Medical Association
  • MedSafetyWeek 2024: The importance of adverse reaction reports and the role pharmacists play in the German spontaneous reporting system from the point of view of the Drug Commission of German Pharmacists (AMK)
  • #MedSafetyWeek: Preventing side effects
  • A feasibility study for the risk evaluation of COVID-19 vaccines (RiCO) at the population level in Germany – utilisation of various secondary data bodies for pharmacovigilance and further research
  • Reports from BfArM and PEI
  • PRAC recommendations within EU referral procedures – July to September 2024
  • Revised product information wording – Extracts from the PRAC recommendations on signals
  • References to direct healthcare professional communications (Rote-Hand-Briefe) and safety information

Further Information

Bulletin on Drug Safety, Issue 3/2024 (German only)
www.pei.de/bulletin-safety

Updated: 30.09.2024