Paul-Ehrlich-Institut

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Bulletin on Drug Safety - Current Issue 4/2020 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 on current aspects of the assessment of drugs from both federal institutes. 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 language.

Topics of the Current Issue

  • Editorial: Vaccines against COVID-19
  • Prescription of teratogenic drugs in women of reproductive age in Germany
  • Small interfering RNA (siRNA) as a drug: principles of action and effects
  • Pharmacovigilance inspections - BfArM and PEI questionnaire on risk-based inspection planning
  • Survey on the tolerability of COVID-19 vaccines using a newly developed smartphone app SafeVac 2.0
  • Reports from BfArM and PEI
  • PRAC recommendations within the framework of EU referral procedures – September to November 2020
  • Revision of the product information wording
  • References to ‘Dear Doctor Letter’ (Rote-Hand-Brief) and safety information

Further Information

Bulletin on Drug Safety, Issue 4/2020 (German only)
www.pei.de/bulletin-safety

Updated: 22.12.2020