The STAR Compass to Guide Future Pharmacovigilance Based on a 10-Year Review of the Strengthened EU System-Reference-Cited by-同舟云学术

The STAR Compass to Guide Future Pharmacovigilance Based on a 10-Year Review of the Strengthened EU System

Published:2024-07-10 Issue:10 Volume:47 Page:941-956
ISSN:0114-5916
Container-title:Drug Safety
language:en
Short-container-title:Drug Saf

Author:

Bahri Priya^ORCID,Genov Georgy,Arlett Peter,Šarinić Viola Macolić,Korakianiti Evdokia,Nolte Alexis,Huber Martin,Straus Sabine M. J. M.

Publisher

Springer Science and Business Media LLC

Link

https://link.springer.com/content/pdf/10.1007/s40264-024-01451-3.pdf

Reference97 articles.

1. European Union. Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use (amended further by Directive 2012/26/EU).

2. European Union. Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products.

3. European Medicines Agency (EMA). Innovation in medicines. Amsterdam: EMA. https://www.ema.europa.eu/en/human-regulatory/research-development/innovation-medicines. Accessed 18 Oct 2023.

4. European Medicines Agency (EMA). Regulatory science strategy. Amsterdam: EMA. https://www.ema.europa.eu/en/about-us/how-we-work/regulatory-science-strategy. Accessed 18 Oct 2023.

5. European Medicines Agency (EMA). Big data. Amsterdam: EMA. https://www.ema.europa.eu/en/about-us/how-we-work/big-data. Accessed 19 Oct 2023.