Assessing the Value of System Theoretic Process Analysis in a Pharmacovigilance Process: An Example Using Signal Management-Reference-Cited by-同舟云学术

Assessing the Value of System Theoretic Process Analysis in a Pharmacovigilance Process: An Example Using Signal Management

Published:2017-07-10 Issue:4 Volume:31 Page:267-278
ISSN:1178-2595
Container-title:Pharmaceutical Medicine
language:en
Short-container-title:Pharm Med

Author:

Adesina Ajibade A.,Hussain Qasim,Pandit Sreenivas,Rejzek Martin,Hochberg Alan M.

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology

Link

http://link.springer.com/article/10.1007/s40290-017-0195-5/fulltext.html

Reference15 articles.

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2. European Medicines Agency. Guideline on good pharmacovigilance practices (GVP): Module IX—signal management. 2012. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129138.pdf . Accessed 15 February 2017.

3. Leveson N. Engineering a safer world: systems thinking applied to safety. Cambridge: MIT Press; 2011.

4. Pawlicki T, Samost A, Brown DW, et al. Application of systems and control theory-based hazard analysis to radiation oncology. Med Phys. 2016;43(3):1514–30.

5. Dokas IM, Feehan J, Imran S. EWaSAP: an early warning sign identification approach based on a systemic hazard analysis. Saf Sci. 2013;58:11–26.

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