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The impact of parallel regulatory–health technology assessment scientific advice on clinical development. Assessing the uptake of regulatory and health technology assessment recommendations

机译：并行的法规与健康技术评估科学建议对临床发展的影响。评估对法规和卫生技术评估建议的采纳

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AimsThe parallel regulatory–health technology assessment scientific advice (PSA) procedure allows manufacturers to receive simultaneous feedback from both EU regulators and health technology assessment (HTA) bodies on development plans for new medicines. The primary objective of the present study is to investigate whether PSA is integrated in the clinical development programmes for which advice was sought.

机译：目标并行的法规与健康技术评估科学建议（PSA）程序使制造商能够同时收到欧盟法规和健康技术评估（HTA）机构对新药开发计划的反馈。本研究的主要目的是调查是否将PSA整合到寻求建议的临床开发计划中。

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期刊名称 British Journal of Clinical Pharmacology
作者
Giovanni Tafuri; Inês Lucas; Steve Estevão; Jane Moseley; Anne dAndon; Hannah Bruehl; Elangovan Gajraj; Sonia Garcia; Niklas Hedberg; Marco Massari; Andrea Molina; Mercè Obach; Leeza Osipenko; Frank Petavy; Marco Petschulies; Caridad Pontes; Pierluigi Russo; Anja Schiel; Marc Van de Casteele; Eva‐Maria Zebedin‐Brandl; Guido Rasi; Spiros Vamvakas;
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作者单位

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年(卷),期 2018(84),5
年度 2018
页码 1013–1019
总页数 7
原文格式 PDF
正文语种
中图分类药学;
关键词
clinical development European Medicines Agency health technology assessment HTA bodies parallel scientific advice regulatory;

机译：临床开发;欧洲药品管理局;卫生技术评估;HTA机构;平行科学建议;法规;

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1. The impact of parallel regulatory–health technology assessment scientific advice on clinical development. Assessing the uptake of regulatory and health technology assessment recommendations [J] . Tafuri Giovanni, Lucas Inês, Estev?o Steve, British Journal of Clinical Pharmacology . 2018,第5期

机译：并行监管卫生技术评估科学建议对临床发展的影响。评估监管和健康技术评估建议的吸收
2. 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 [J] . BerntgenM., GourvilA., PavlovicM., Value in health: the journal of the International Society for Pharmacoeconomics and Outcomes Research . 2014,第5期

机译：改善法规评估报告对卫生技术评估的贡献-欧洲药品管理局与欧洲卫生技术评估网络之间的合作
3. Regulatory and health technology assessment advice on postlicensing and postlaunch evidence generation is a foundation for lifecycle data collection for medicines [J] . Jane Moseley, Spiros Vamvakas, Michael Berntgen, British journal of clinical pharmacology . 2020,第6期

机译：关于后期和后临时证据生成的监管和健康技术评估建议是药物生命周期数据收集的基础
4. Regulatory recommendations for IoT smart-health care services by using privacy impact assessment (PIA) [C] . Insan Laksana Pribadi, Muhammad Suryanegara 2017 15th International Conference on Quality in Research : International Symposium on Electrical and Computer Engineering . 2017

机译：使用隐私影响评估（PIA）的物联网智能医疗服务监管建议
5. Evaluation of Policy and Research Interventions in Science and Technology: Consequence Assessment of Regulatory and Technology Transfer Programs. [D] . Dias, Mary Beatrice. 2011

机译：科技政策和研究干预措施的评估：监管和技术转让计划的后果评估。
6. Regulatory and health technology assessment advice on postlicensing and postlaunch evidence generation is a foundation for lifecycle data collection for medicines [O] . Jane Moseley, Spiros Vamvakas, Michael Berntgen, 2020

机译：有关许可后和发布后证据生成的法规和卫生技术评估建议是药物生命周期数据收集的基础
7. 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 [O] . Berntgen Michael, Gourvil Anne, Pavlovic Mira, 2014

机译：改善法规评估报告对卫生技术评估的贡献—欧洲药品管理局与欧洲卫生技术评估网络之间的合作
8. Reclamation of Automotive Batteries: Assessment of Health Impacts and Recycling211 Technology. Task 2: Assessment of Health Impacts [R] . Unnasch, S. 1999

机译：汽车电池回收：健康影响评估和回收211技术。任务2：健康影响评估

The impact of parallel regulatory–health technology assessment scientific advice on clinical development. Assessing the uptake of regulatory and health technology assessment recommendations

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