Bulletin on Drug Safety - Current Issue 1/2024 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: Improving medicinal product safety for women and men by taking gender differences into account
- Potential risk of neurodevelopmental disorders in children whose fathers were treated with valproate
- Prescription of antiretroviral medicinal products for women of childbearing age and during pregnancy
- Suspected cases of herpes zoster and pronounced skin reactions associated with vaccination against herpes zoster and postherpetic neuralgia: results of an observational study in individuals vaccinated with Shingrix in Germany
- Gender-specific medicinal product safety – BfArM activities
- Reports from BfArM and PEI
- PRAC recommendations within EU referral procedures – January to March 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 1/2024 (German only)
www.pei.de/bulletin-safety
