Validating Intelligent Automation Systems in Pharmacovigilance: Insights from Good Manufacturing Practices

Author:

Huysentruyt KristofORCID,Kjoersvik Oeystein,Dobracki Pawel,Savage Elizabeth,Mishalov Ellen,Cherry Mark,Leonard Eileen,Taylor Robert,Patel Bhavin,Abatemarco Danielle

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,Toxicology

Reference18 articles.

1. World Health Organization. Pharmacovigilance. 2020. https://www.who.int/medicines/areas/quality_safety/safety_efficacy/pharmvigi/en/. Accessed 4 Sep 2020.

2. Stergiopoulos S, Fehrle M, Caubel P, et al. Adverse drug reaction case safety practices in large biopharmaceutical organizations from 2007 to 2017: an industry survey. Pharm Med. 2019;33:499–510. https://doi.org/10.1007/s40290-019-00307-x.

3. Wynn M, Fauber J. Analysis: reports of drug side effects increase fivefold in 12 years. Milwaukee J Sentin. 2017. https://www.jsonline.com/story/news/investigations/2017/03/17/analysis-reports-drug-side-effects-see-major-increase/99211376/. Accessed 4 Sep 2020

4. Lewis JL, McCallum JF. Utilizing advanced technologies to augment pharmacovigilance systems: challenges and opportunities. Ther Innov Regul Sci. 2020;54:889–99. https://doi.org/10.1007/s43441-019-00023-3.

5. European Commission. Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council. https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:159:0005:0025:EN:PDF. Accessed 20 Nov 2020.

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