Specialist Cohort Event Monitoring Studies: A New Study Method for Risk Management in Pharmacovigilance

Author:

Layton Deborah,Shakir Saad A. W.

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,Toxicology

Reference24 articles.

1. European Medicines Agency (EMA). Guideline on good pharmacovigilance practices (GVP) module viii—post-authorisation safety studies (rev 1). EMA/813938/2011. London: EMA, 19 April 2013.

2. European Network of Centres of Excellence for Pharmacoepidemiology and Pharmacovigilance (ENCEPP). Guide on methodological standards in pharmacoepidemiology (revision 2). EMA/95098/2010. London: ENCEPP, 18 June 2013.

3. Layton D, Hazell L, Shakir SA. Modified prescription-event monitoring studies: a tool for pharmacovigilance and risk management. Drug Saf. 2011.

4. Layton D, Shakir SAW. Prescription-event monitoring. In: Strom BL, Kimmel SE, Hennessy S, editors. Pharmacoepidemiology, 5th edn. Chichester, UK: John Wiley & Sons Ltd; 2011. p. 301–330.

5. Suissa S. Immortal time bias in observational studies of drug effects. Pharmacoepidemiol Drug Saf. 2007;16(3):241–9.

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