Strengthening standards, transparency, and collaboration to support medicine evaluation: Ten years of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP).
Strengthening standards, transparency, and collaboration to support medicine evaluation: Ten years of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP).
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DOI：
10.1002/pds.4381
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发表时间：
2018-03
影响因子：
2.6
通讯作者：
ENCePP Steering Group
中科院分区：
文献类型：
--
作者：
Kurz X;Perez-Gutthann S;ENCePP Steering Group
欧洲药品管理局（EMA）负责对欧盟（EU）的药品进行科学评估、监督和安全性监测，以确保其获益大于风险。虽然药品安全性监测的根本在于建立由保健专业人员和患者自发报告可疑不良反应的机制，但长期以来人们一直承认使用包括观察性研究在内的全方位证据的重要性。1-3 2006年欧盟引入的风险管理系统强调了能力建设的必要性，并促进了多中心独立许可后研究的开展，以调查欧洲人群中的重要风险或缺失信息。4 2006年3月，EMA联系了通过国际药物流行病学学会（ISPE）和国家药品监管机构确定的欧洲90多个学术中心，要求提供有关其在药物流行病学和药物警戒方面的专业知识和活动的信息。在接下来的12个月里，与学术和其他研究中心、制药行业、其他现有临床网络、EMA科学委员会和欧盟委员会的代表讨论了独立观察性研究合作的可能模式。5欧洲药物流行病学和药物警戒中心网络（ENCePP; www.恩塞普欧盟）于2007年6月28日启动，有79名参与者同意在透明、科学独立和共同质量标准的基础上建立一个积极的研究网络。欧洲药物流行病学和药物警戒中心网络于2008年8月在第24届药物流行病学和治疗风险管理国际会议的研讨会上提出。6十年过去了，我们回顾了ENCePP的主要成就，讨论了其对欧洲药品获益-风险评价的影响，并概述了未来的前景。
1 BACKGROUNDThe European Medicines Agency (EMA) has the responsibility for the scientific evaluation, supervision, and safety monitoring of medicines in the European Union (EU) to ensure that their benefits outweigh their risks. While the roots of medicines' safety monitoring lie in the development of mechanisms for spontaneous reporting of suspected adverse reactions by health-care professionals and patients, the importance of using the full spectrum of evidence including observational studies has long been acknowledged. 1-3 The risk management system introduced in the EU in 2006 highlighted the need to build capacity and to facilitate the conduct of multicenter independent postauthorization studies to investigate important risks or missing information in European populations. 4 In March 2006, the EMA contacted more than 90 academic centers in Europe identified through the International Society for Pharmacoepidemiology (ISPE) and national drug regulatory authorities to request information on their expertise and activities in pharmacoepidemiology and pharmacovigilance. Over the following 12 months, possible models for collaboration on independent observational studies were discussed with representatives of academic and other research centers, pharmaceutical industry, other existing clinical networks, EMA scientific committees, and the European Commission. 5 The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP; www. encepp. eu) was launched on June 28, 2007 with 79 participants who agreed to develop an active research network based on principles of transparency, scientific independence, and common quality standards. The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance was presented in a symposium at the 24th International Conference on Pharmacoepidemiology and Therapeutic Risk Management in August 2008. 6 Ten years on, we review ENCePP's main achievements, discuss its impact on the benefit-risk evaluation of medicinal products in Europe, and outline future perspectives.
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影响因子：
2.6
作者：
Wang SV;Schneeweiss S;Berger ML;Brown J;de Vries F;Douglas I;Gagne JJ;Gini R;Klungel O;Mullins CD;Nguyen MD;Rassen JA;Smeeth L;Sturkenboom M;joint ISPE-ISPOR Special Task Force on Real World Evidence in Health Care Decision Making
通讯作者：
joint ISPE-ISPOR Special Task Force on Real World Evidence in Health Care Decision Making
影响因子：
2.6
作者：
Berger, Marc L.;Sox, Harold;Daniel Mullins, C.
通讯作者：
Daniel Mullins, C.
影响因子：
3.4
作者：
Engel, Pierre;Almas, Mariana Ferreira;Dreyer, Nancy Ann
通讯作者：
Dreyer, Nancy Ann
影响因子：
2.6
作者：
Blake, Kevin V.;deVries, Corinne S.;Fitt, Henry
通讯作者：
Fitt, Henry
影响因子：
4.2
作者：
Santoro A;Genov G;Spooner A;Raine J;Arlett P
通讯作者：
Arlett P