Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Pharmacology,Toxicology
Reference28 articles.
1. CHMP Guideline on registry-based studies. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-registry-based-studies_en-0.pdf. Accessed 3 May 2022.
2. Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. Accessed 3 May 2022.
3. Blake KV, de Vries CS, Arlett P, et al. Increasing scientific standards, independence and transparency in post-authorisation studies: the role of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance: ENCePP AND POST-AUTHORISATION MEDICINE RESEARCH. Pharmacoepidemiol Drug Saf. 2012;21:690–6. https://doi.org/10.1002/pds.3281.
4. McGettigan P, Alonso Olmo C, Plueschke K, et al. Patient registries: an underused resource for medicines evaluation: operational proposals for increasing the use of patient registries in regulatory assessments. Drug Saf. 2019;42:1343–51. https://doi.org/10.1007/s40264-019-00848-9.
5. Jonker CJ, Kwa MSG, van den Berg HM, et al. Drug registries and approval of drugs: promises, placebo, or a real success? Clin Ther. 2018;40:768–73. https://doi.org/10.1016/j.clinthera.2018.04.005.
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