为儿童提供更好的药物:在 EFGCP 年度儿科会议上吸取经验教训并分享心得。

IF 2 4区 医学 Q4 MEDICAL INFORMATICS Therapeutic innovation & regulatory science Pub Date : 2024-11-13 DOI:10.1007/s43441-024-00710-w
Solange Corriol-Rohou, Sabine Ingeborg Fürst-Recktenwald, Elin-Haf Davies, Martine Dehlinger-Kremer, Mark A Turner
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引用次数: 0

摘要

多年来,欧洲良好临床实践论坛 (EFGCP) 儿童药品工作组每年都会组织一次儿科会议。过去,这项活动是与欧洲药品管理局(European Medicines Agency)和药物信息协会(Drug Information Association,DIA)联合举办的。该会议为所有参与儿科药物开发的人员(即监管机构、HTA 机构、患者代表、学术界和业界)提供了一个分享学习成果和提高对新监管要求认识的机会,这些新监管要求对优化儿科药物开发具有重要意义。2021 年会议的主题是 "挑战与解决方案--前进之路",而 2022 年会议的主题是 "取得的进展与持续的挑战"。由于 COVID-19 大流行,这两次会议都是以虚拟形式举办的。然而,这并没有影响会议的出席率和价值,因为会议议程广泛而有吸引力,利益相关者广泛参与,对改善儿童获得创新药物的主要问题进行了全面概述。
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Better Medicines for Children: Lessons Learnt and Share Learnings at the EFGCP Annual Paediatric Conferences.

For many years, the European Forum for Good Clinical Practice (EFGCP) Children Medicines Working Party has organised a Paediatric conference annually. In the past, this event was organised jointly with the European Medicines Agency who was used to host it, along with the Drug Information Association (DIA). This conference is the opportunity for all involved in paediatric drug development, i.e., regulators, HTA bodies, patients' representatives, academia and industry, to share learnings and raise awareness about new regulatory requirements of interest to optimise paediatric drug development. The theme of the 2021 conference was "Challenges and Solutions - the path forward" while in 2022 it focused on "Progress made and Continuing Challenges". Because of the COVID-19 pandemic these two conferences were organised virtually. However, this has not impacted the attendance and value of the conference, since because of a broad and attractive agenda there was a wide stakeholder participation, which provided a compendious overview of the leading issues to improve children's access to innovative medicines.

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来源期刊
Therapeutic innovation & regulatory science
Therapeutic innovation & regulatory science MEDICAL INFORMATICS-PHARMACOLOGY & PHARMACY
CiteScore
3.40
自引率
13.30%
发文量
127
期刊介绍: Therapeutic Innovation & Regulatory Science (TIRS) is the official scientific journal of DIA that strives to advance medical product discovery, development, regulation, and use through the publication of peer-reviewed original and review articles, commentaries, and letters to the editor across the spectrum of converting biomedical science into practical solutions to advance human health. The focus areas of the journal are as follows: Biostatistics Clinical Trials Product Development and Innovation Global Perspectives Policy Regulatory Science Product Safety Special Populations
期刊最新文献
Testing the Feasibility of a Digital Point of Care Solution for the Trusted Near Real-Time Bidirectional Exchange of Novel and Informative Adverse Event Information. Better Medicines for Children: Lessons Learnt and Share Learnings at the EFGCP Annual Paediatric Conferences. An Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience Database for MAGnetic Expansion Control Spinal Rods.
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