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欧洲制药企业协会 - 第13届药物警戒会议(2020年1月29日 - 荷兰阿姆斯特丹)

Medicines for Europe - 13th Pharmacovigilance Conference (January 29, 2020 - Amsterdam, the Netherlands).

作者信息

Hamaui Cuadrado S

机构信息

Clarivate Analytics, Barcelona, Spain.

出版信息

Drugs Today (Barc). 2020 Feb;56(2):165-168. doi: 10.1358/dot.2020.56.2.3140446.

DOI:10.1358/dot.2020.56.2.3140446
PMID:32163531
Abstract

This year, following the European Medicines Agency (EMA) relocation due to the Brexit process, the 13th Pharmacovigilance Conference organized by Medicines for Europe took place in Amsterdam, the Netherlands. The pharmaceutical industry is usually associated with the development and launch of new drugs for the market, but it is also committed to finding new ways of making existing drugs and processes (e.g., pharmacovigilance [PV]) more efficient and better for patients. In relation to this, a variety of topics were on the agenda at the conference, including updates on the progress of the EudraVigilance (EV) system for monitoring and analyzing potential drug-related adverse events, as well as highlights on the E.U. Network Strategy to 2025 and the EMA multi-annual work program related to big data acceptability, electronic product information (ePI) Key Principles and Roadmap for implementation, and work-sharing ongoing projects for achieving harmonization of requirements and processes. Adrian van den Hoven (Director General, Medicines for Europe) opened the conference looking towards the future, emphasizing what the current PV system needs to do in order to adapt to new landscapes. With big data, robotization, automation or globalization, there are many opportunities to streamline and become smarter on the horizon.

摘要

今年,由于英国脱欧进程,欧洲药品管理局(EMA)进行了搬迁,在此之后,由欧洲制药工业协会联合会(Medicines for Europe)组织的第13届药物警戒会议在荷兰阿姆斯特丹举行。制药行业通常与新药的研发和推向市场相关联,但它也致力于寻找新方法,使现有药物和流程(如药物警戒[PV])对患者而言更高效、更有益。与此相关,会议议程涵盖了多个主题,包括用于监测和分析潜在药物相关不良事件的欧洲药物警戒系统(EV)的进展更新,以及到2025年的欧盟网络战略和与大数据可接受性、电子产品信息(ePI)实施关键原则和路线图相关的EMA多年工作计划亮点,还有为实现要求和流程协调而开展的工作共享项目。欧洲制药工业协会联合会总干事阿德里安·范登·霍芬宣布会议开幕,并展望未来,强调了当前药物警戒系统为适应新情况需要做的事情。随着大数据、机器人化、自动化或全球化的发展,未来有很多机会实现流程简化并变得更加智能。

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