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将药学确立为一门专业所面临的挑战:专业身份和职业发展路径的需求:教育与培训的作用

Challenges to Establishing Pharmaceutical Medicine as a Profession: Needs for Professional Identity and a Career Pathway: Role of Education and Training.

作者信息

Silva Honorio, Baroutsou Varvara, Criscuolo Domenico, Guptha Soneil, Jurczynska Anna, Kerpel-Fronius Sandor, Klech Heinrich, Klingmann Ingrid

机构信息

The Academy of Global Medicines Development Professionals (GMDP Academy), New York, USA.

International Federation of Associations of Pharmaceutical Physician and Pharmaceutical Medicine, (IFAPP), Woerden, The Netherlands.

出版信息

Pharmaceut Med. 2025 Apr 19. doi: 10.1007/s40290-025-00559-w.

Abstract

Pharmaceutical Medicine (PM) was defined by its founding pharmaceutical physicians as a "medical/scientific discipline concerned with the discovery, development, evaluation, registration, monitoring, and medical aspects of the commercialization of medicines, for the benefit and the health of the community." Conceived as a medical specialty, the discipline encompassed several health-related professions and occupations, such as medicine, pharmacy, clinical pharmacology, drug safety and pharmacovigilance, pharmaceutical sciences, biology, health economics and others. Historically, non-medically qualified medicines development scientists from health-related disciplines have gradually grown into the medical roles within pharmaceutical organizations, regulatory agencies, and contract research organizations and today physicians and non-physicians lead drug development groups. Medicines Development Sciences (MDS) has been accepted as an alternative name. The practice of the disciplines involved in PM/MDS has evolved from an occupation to be accepted as a distinct profession, by meeting well established criteria. Despite thousands of health professionals participating today in medicines development, their awareness of the existence of this discipline, and its evolution from occupation to profession is low. The lack of professional identity and a clear career path have been identified as key factors limiting the advancement of this profession. This position paper aims to consolidate PM/MDS as an advanced profession in health sciences and propose a career path that is envisioned and championed by educational standards setting organizations like the International Federation of Association of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP), PharmaTrain, and Global Medicines Development Professionals (GMDP) Academy with education and training as pillars for its achievement.

摘要

药物医学(PM)由其创始的药物医学医师定义为“一门医学/科学学科,涉及药物的发现、开发、评估、注册、监测以及商业化的医学方面,以造福社会并促进公众健康”。作为一门医学专业,该学科涵盖了多个与健康相关的职业,如医学、药学、临床药理学、药物安全与药物警戒、制药科学、生物学、卫生经济学等。从历史上看,来自健康相关学科的非医学专业合格的药物开发科学家已逐渐在制药公司、监管机构和合同研究组织中承担起医学角色,如今医生和非医生共同领导药物开发团队。药物开发科学(MDS)已被视为一个替代名称。参与PM/MDS的各学科实践已从一种职业发展成为一门独特的专业,符合既定的标准。尽管如今有成千上万的健康专业人员参与药物开发,但他们对这一学科的存在及其从职业向专业的演变的认识却很低。缺乏专业认同感和明确的职业道路已被确定为限制该专业发展的关键因素。本立场文件旨在巩固PM/MDS作为健康科学领域的一门高级专业,并提出一条由国际药物医学医师协会联合会(IFAPP)、PharmaTrain和全球药物开发专业人员(GMDP)学院等教育标准制定组织设想并倡导的职业道路,以教育和培训作为实现这一目标的支柱。

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