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Links of interest

See also: ENCePP Linking Policy

 

• EU Regulatory Bodies

 

European Medicines Agency
European Commission - DG Health and Consumer Protection
European Commission - DG Research & Innovation/Health

 

• Learned Societies

 

International Society for Pharmacoepidemiology (ISPE)
International Society for Pharmacovigilance (ISoP)
International Society for Pharmacoeconomics and Outcomes Research (ISPOR)
European Association for Clinical Pharmacology and Therapeutics (EACPT)

 

• Training Opportunities

 

European Programme in Pharmacovigilance and Pharmacoepidemiology (Eu2P)
Interactive Platform of Postgraduate Training Opportunities

 

• Other links of interest

 

FDA Sentinel Initiative
DSEN Canada (Drug Safety and Effectiveness Network)
EU Paediatric Network (EnprEMA)
EU Clinical Trials Register
PROTECT Project: Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium
EHR4CR Project: Electronic Health Records for Clinical Research
EUnetHTA - European Network for Health Technology Assessment
Medicines for older people (EMA)
Uppsala Monitoring Centre (UMC)

 

• Articles and documents referencing ENCePP

 

Postmarketing studies of drug safety (Schneeweiss, S. BMJ 2011;342:d342 - published 8 February 2011)
Patient-Centered Outcomes Research Institute (PCORI) Methodology Committee Resource Guide (developed by the U.S. National Pharmaceutical Council, February 2011)
Making Observational Studies Count: Shaping the Future of Comparative Effectiveness Research (Dreyer, NA. Epidemiology 2011;22:295-297 - published May 2011)
European Medicines Agency review of post-authorisation studies with implications for the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (Blake, KV et al; PDS 2011;20: 1021-1029. doi: 10.1002/pds.2209 - published August 2011)
Why Drug Safety Should not Take a Back Seat to Efficacy (PLoS Medicine Editors. PLoS Med 2011;8(9):e1001097 - published September 2011)
The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance: Application to Diabetes and Vascular Disease (Blake, KV et al. BJD&VD 2011;11:304 - published November 2011)
ENCePP Approval Process (Ehrenstein, V. PRM Newsletter 2011;10:1-2 - published December 2011)
Should Preregistration of Epidemiologic Study Protocols Become Compulsory? (Lash, TL and Vandenbroucke JP. Epidemiology 2012;23:184-188 - published March 2012)
Prospective Observational Studies to Assess Comparative Effectiveness: The ISPOR Good Research Practices Task Force Report (Berger, ML et al. Value in Health 2012;15:217-230 - published March 2012)
Open Clinical Trial Data for All? A View from Regulators (Eichler, H-G et al. PLoS Med 2012;9(4):e1001202 - published April 2012)
Increasing scientific standards, independence and transparency in post-authorisation studies: the role of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (Blake KV et al. PDS 2012;21(7):690-696 - published July 2012)

Why all Pharmacoepidemiology and Pharmacovigilance studies should be entered into ENCePP’s electronic register of studies (Murray, ET and Maier WC. PRM 2012;12:8 - published August 2012)

Making available observational study protocols and results: the role of ENCePP (on behalf of ENCePP - Letter to the Editor, Circulation: Cardiovascular Quality and Outcomes - published 4 September 2012)
A Pathway to Improved Prospective Observational Post-Authorization Safety Studies (Kiri VA. Drug Saf 2012; 35 (9): 711-724 - published September 2012)
An inventory of European data sources for the long-term safety evaluation of methylphenidate (Murray, ML et al. Eur Child Adolesc Psychiatry 2013; 22:605-618 - published March 2013)
Towards a prevention model of health care (Breckenridge A, Eichler HG. Nature Reviews|Drug Discovery 2013; 12:563-564 - published August 2013)
The European Medicine Agency's use of prioritised independent research for best evidence in regulatory action on diclofenac (Arlett, P et al. Pharmacoepidem. Drug safe., 23: 431-434. doi: 10.1002/pds.3594 - published February 2014)
A compilation of research working groups on drug utilisation across Europe (Sabaté, M et al. BMC Res Notes. 2014 Mar 13;7:143)
A Description of ENCePP as a Global Resource for Pharmacovigilance and Pharmacoepidemiology (Mann's Pharmacovigilance Third Edition, Chapter 23, February 2014)

Guidelines for good pharmacoepidemiology practice (GPP) (Public Policy Committee, International Society of Pharmacoepidemiology. Pharmacoepidemiol Drug Saf 2016, 25: 2–10)

The ADVANCE Code of Conduct for collaborative vaccine studies (Kurz X et al. Vaccine 2017.02.039 – published online March 2017)