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日本医药学会(JAPhMed)关于医疗科学联络专员(MSL)职业标准的提案

Proposal of Standard for Medical Science Liaison (MSL) Profession in Japan: A Viewpoint from the Japanese Association of Pharmaceutical Medicine (JAPhMed).

机构信息

Japanese Association of Pharmaceutical Medicine, Shibaura Shimizu building, 4-15-33, Shibaura, Minato-ku, Tokyo, 108-0023, Japan.

Kyowa Kirin Co., Ltd., Tokyo, Japan.

出版信息

Pharmaceut Med. 2020 Oct;34(5):315-326. doi: 10.1007/s40290-020-00355-8.

DOI:10.1007/s40290-020-00355-8
PMID:33030675
Abstract

Medical science liaisons (MSLs) are field-based professionals sited in medical affairs (MA) departments who contribute to the generation of medical evidence and exchange advanced medical and scientific information with healthcare professionals to standardize treatments and maximize the value of medical products for patient outcomes. As such, it is essential for companies to have MSL training programs that cover areas such as advanced scientific expertise, pharmaceutical regulations, and medical communication proficiency and to certify the knowledge and skills that enable MSLs to perform their tasks effectively. The lack of a standardized training curriculum, assessment of MSL capabilities, and key performance indicators (KPIs) in Japan has made it difficult for MSLs to carry out these tasks. It is important to clarify the status of MSLs in MA divisions within the Japanese pharmaceutical industry. The mission of the Japanese Association of Pharmaceutical Medicine (JAPhMed) is to promote pharmaceutical medicine by enhancing the knowledge, expertise, and skills of pharmaceutical professionals. JAPhMed established an accreditation system for the MSL certification programs of individual companies in early 2015 and then embarked on defining the individual MSL qualifications from late 2015 to mid-2017. Here, we describe the MSL recommendation that covers (1) MA in Japan, (2) definition of MSL, (3) roles and activities of MSLs, (4) regulation and compliance for MSLs, (5) qualification requirements for MSLs, (6) KPIs for MSLs, and (7) a training curriculum for MSLs. In the training curriculum, JAPhMed considered the relevance of each part of the training curriculum in terms of the fixed roles and activities of MSLs.

摘要

医学联络官(MSL)是医学事务(MA)部门中的现场专业人员,他们致力于生成医学证据,并与医疗保健专业人员交流先进的医学和科学信息,以规范治疗方法并最大限度地提高医疗产品的价值,从而改善患者的治疗效果。因此,公司必须拥有涵盖高级科学专业知识、药物法规以及医学沟通能力等领域的 MSL 培训计划,并对 MSL 有效履行职责所需的知识和技能进行认证。日本缺乏标准化的培训课程、MSL 能力评估以及关键绩效指标(KPI),这使得 MSL 难以开展这些工作。明确日本制药行业 MA 部门中 MSL 的地位非常重要。日本制药医疗协会(JAPhMed)的使命是通过增强制药专业人员的知识、专长和技能来促进制药医学的发展。JAPhMed 在 2015 年初为各个公司的 MSL 认证计划建立了认证体系,随后从 2015 年末到 2017 年年中,开始定义单个 MSL 的资质要求。在这里,我们描述了 MSL 的建议,涵盖了 (1) 日本的 MA、(2) MSL 的定义、(3) MSL 的角色和活动、(4) MSL 的监管和合规要求、(5) MSL 的资质要求、(6) MSL 的 KPI 以及 (7) MSL 的培训课程。在培训课程中,JAPhMed 考虑了培训课程的每个部分在 MSL 的固定角色和活动方面的相关性。

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引用本文的文献

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Ther Innov Regul Sci. 2022 Jan;56(1):96-103. doi: 10.1007/s43441-021-00333-5. Epub 2021 Aug 20.