The European Pharmacopoeia has revised 5 monographs on sartans containing a tetrazole ring. The revision concerns a new wording of the “Production” section and deletion of the N-nitrosamines test section. The implementation date for these 5 revised monographs is 1 April 2021.
March 5, 2021
Pharma D&S Career Linkedin page
Discover the new Linkedin page Pharma D&S Career! You will find open job positions, our participation at Career Days and job fairs and all related news.
March 5, 2021
First AIFA Report on COVID-19 Vaccine Surveillance
The Italian Medicines Agency has published the first COVID-19 Vaccine Surveillance Report. The Report confirm that the two mRNA vaccines have a good safety profile. The analysis performed indicates the great capacity of the pharmacovigilance system to monitor safety.
Q&A: Good clinical practice (GCP)
EMA published a guidance in forms of Questions and Answers on good clinical practices. (GCP). Table of contents are:
- Investigational medicinal products (IMPs) in bioavailability and bioequivalence trials
- GCP matters
- Expectations of European Union (EU) competent authorities on the use of electronic trial master files
- Records of study subject data relating to clinical trials
February 25, 2021
European Pharmacovigilance Congress 2024
November 18-19 | VIRTUAL + November 22 | FACE to FACE in MILAN
Continue readingPharma Microbiology Congress 2024
October 28-29 | VIRTUAL + November 8 | FACE to FACE in FLORENCE
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