Bulletin on Drug Safety - Current Issue 2/2020 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 risk 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: Drug safety and medical care in times of the COVID-19 pandemic
- Cyproterone acetate: meningeoma risk leads to further restrictions on use
- Risk factors for intussusception in infants less than 1 year of age with a special focus on rotavirus vaccines: retrospective multicenter matched case-control study
- The risk management plan: Refocusing through the second revision of Module V of the EU Guide to Good Pharmacovigilance Practice
- Research project INA: Analysis of differential gene and protein expression for the in vitro detection of a drug allergy
- Reports from BfArM and PEI
- PRAC recommendations within the framework of EU referral procedures – April to June 2020
- Revision of the product information wording - extracts from the PRAC recommendations on signals
- References to 'Dear Doctor Letter' (Rote-Hand-Brief) and safety information
Further Information
Bulletin on Drug Safety, Issue 2/2020 (German only)
www.pei.de/bulletin-safety
