Guidelines

The world of evidence is changing, with regulators and payers increasingly seeking the demonstration of value beyond clinical outcomes. YOLARX provides below a selection of guidelines and guidance documents established by international pharmacoepidemiology societies or organisations and regulators. They are listed in order of appearance with the most recent publication on top.

YOLARX has created these links for educational and research purposes only, and cannot take responsibility for content of third party web sites. Inclusion of a link does not imply endorsement of or association with YOLARX.

Pharmacoepidemiology and clinical studies:

• Guide on Methodological Standards in Pharmacoepidemiology (Revision 6, July 2017); European Medicines Agency (EMA)/European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP); last accessed 20 March 2018

• International Ethical Guidelines for Health-related Research Involving Humans (2016); Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO); last accessed on 20 March 2018

• Guidelines for Good Pharmacoepidemiology Practices (GPP) (Revision 3, June 2015); ISPE – International Society of Pharmacoepidemiology; last accessed on 20 March 2018

• Guidance for Industry and FDA Staff. Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data (May 2013); Food and Drug Administration (FDA); last accessed on 20 March 2018

• Guidelines for Good Database Selection and Use in Pharmacoepidemiology Research; Hall et al.; Pharmacoepidemiology and drug safety (2011); DOI: 10.1002/pds.2229; last accessed on 20 March 2018

• ICH Harmonized Tripartite Guideline. Statistical Principles for Clinical Trials E9 (1998); International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use; last accessed on 20 March 2018

• ICH Harmonized Tripartite Guideline. Structure and Content of Clinical Study Reports E3 (1995); International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use; last accessed on 20 March 2018

• Community code relating to veterinary medicinal products. Directive 2001/82/EC of 6 November 2001; Official Journal of the European Union; last accessed on 20 March 2018

• Food and Drug Administration (FDA) Good Clinical Practice (GCP). Electronic Records; Electronic Signatures (21 CFR Part 11); last accessed on 20 March 2018

Pharmacovigilance and risk management:

• Guideline on Good Pharmacovigilance Practices (GVP) Module VIII – Post Authorisation Safety Studies (Revision 3, October 2017); European Medicines Agency (EMA)/Heads of Medicines Agencies (HMA); last accessed on 20 March 2018

• Practical approaches to risk minimisation for medicinal products: Report of CIOMS Working Group IX.  Geneva, Switzerland: Council for International Organizations of Medical Sciences (CIOMS), 2014. last accessed on 20 March 2018

• Performance of Pharmacovigilance Activities. Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012; Official Journal of the European Union; last accessed on 20 March 2018

• EU Pharmacovigilance Legislation (2012); last accessed on 20 March 2018

• European Medicines Agency (EMA) Good Pharmacovigilance Practice (GVP); last accessed on 20 March 2018

• Food and Drug Administration (FDA) Guidance for Industry. Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment (March 2005); last accessed on 20 March 2018

• ICH Harmonized Tripartite Guideline. Pharmacovigilance Planning E2E (2004); International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use; last accessed on 20 March 2018

Systematic reviews and meta-analyses:

• PRISMA for Systematic Review Protocols (PRISMA-P): Moher D, et al. Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) 2015 statement. Syst Rev. 2015;4(1):1. doi: 10.1186/2046-4053-4-1; last accessed on 20 March 2018

• Preferred Reporting Items for Systematic Reviews and Meta-Analyses: The PRISMA Statement; Moher D, Liberati A, Tetzlaff J, Altman DG, The PRISMA Group (2009). BMJ 2009;339:b2535, doi: 10.1136/bmj.b2535; last accessed on 20 March 2018

• The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement; last accessed on 20 March 2018

• The Meta-analysis Of Observational Studies in Epidemiology (MOOSE) Statement (2000). Stroup DF et al. Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group. JAMA 2000; 283, pp. 2008–12. doi:10.1001/jama.283.15.2008; last accessed on 20 March 2018