Improving the Contribution of Regulatory Assessment Reports to Health Technology Assessments—A Collaboration between the European Medicines Agency and the European network for Health Technology Assessment
| Autor: | Hans-Georg Eichler, Anne Gourvil, Michael Berntgen, Finn Børlum Kristensen, Wim G. Goettsch, Mira Pavlovic |
|---|---|
| Rok vydání: | 2014 |
| Předmět: |
European level
Technology Assessment Biomedical business.industry European Medicines Agency (EMA) Health Policy Biomedical Technology Public Health Environmental and Occupational Health Health technology Information needs Public relations Technology assessment Agency (sociology) Humans Medicine European Public Assessment Reports (EPARs) European Union Cooperative Behavior Policy Making business European network for Health Technology Assessment (EUnetHTA) relative effectiveness assessment Relevant information Inclusion (education) |
| Zdroj: | Value in Health. 17:634-641 |
| ISSN: | 1098-3015 |
| DOI: | 10.1016/j.jval.2014.04.006 |
| Popis: | In response to a recommendation from the Pharmaceutical Forum, the European Medicines Agency and the European network for Health Technology Assessment initiated a collaboration with the aim to improve the contribution regulatory assessment reports can make to the assessment of relative effectiveness of medicinal products by health technology assessment bodies. This collaboration on improving European Public Assessment Reports (EPARs) started in February 2010 and was performed over 2 years. As a result, the templates for preparing EPARs were revised to better address the needs of heath technology organizations. The better understanding of information needs was a key outcome of the collaboration. To ascertain whether these template changes led to the inclusion of relevant information, a review of a small set of EPARs for recently approved medicinal products was carried out in parallel by both the European network for Health Technology Assessment and the European Medicines Agency. This report provides an account of this project on improving EPARs, which is part of the ongoing dialogue between regulators and health technology assessment bodies on a European level to support policymaker decisions in the future. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full Text from ScienceDirect