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) |
Strengthening standards, transparency, and collaboration to support medicine evaluation: Ten years of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) (Kurz X, Perez‐Gutthann S, the ENCePP Steering Group. Pharmacoepidemiol Drug Saf. 2018;1–11.) |
Electronic healthcare databases in Europe: descriptive analysis of characteristics and potential for use in medicines regulation ( Pacurariu A, Plueschke K, McGettigan P, et al. BMJ Open 2018;8:e023090. doi: 10.1136/bmjopen-2018-023090) |
The ENCePP Code of Conduct: A best practise for scientific independence and transparency in noninterventional postauthorisation studies (Gini R, Fournie X, Dolk H, et al. Pharmacoepidemiol Drug Saf. 2019;1–12.) |
Patient Registries: An Underused Resource for Medicines Evaluation (McGettigan P, Alonso Olmo C, Plueschke K, et al. Drug Saf (2019). https://doi.org/10.1007/s40264-019-00848-9) |