Stonier Peter D, Silva Honorio, Boyd Alan, Criscuolo Domenico, Gabbay Felicity J, Imamura Kyoko, Kesselring Gustavo, Kerpel-Fronius Sandor, Klech Heinrich, Klingmann Ingrid
Faculty of Pharmaceutical Medicine, Royal College of Physicians, London, United Kingdom.
International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine, Woerden, Netherlands.
Front Pharmacol. 2020 Mar 19;11:282. doi: 10.3389/fphar.2020.00282. eCollection 2020.
The evolution of postgraduate vocational education and training in pharmaceutical medicine is described alongside the growth of this scientific-medical discipline and profession for the development of new medicines. Over the past 50 years, whilst the training of competent professionals for their work has been paramount, this has paralleled the need to engage with the rapid and complex changes in R&D technologies, patient and healthcare system needs, and the ethical and regulatory obligations applied to the development of medicines throughout their lifecycle. The move from unstructured training to formal programs with syllabus, curricula and assessments for certification, has been accompanied by educational changes to outcomes-based, learner-centered, competency-based programs. The evolution of education and training along with the development of the set of 57 core competencies for professional practitioners in pharmaceutical medicine are described within the competence framework of seven domains: discovery of medicines and early development; clinical development and clinical trials; medicines regulation; drug safety and surveillance; ethics and subject protection; healthcare marketplace; communication and management. The application of the core competencies in a harmonized, international platform of education and training in medicines development at the undergraduate, postgraduate and continuing professional development levels would invigorate the potential for having a competent workforce with the intent to provide faster access to better and appropriate medicines for patients worldwide.
随着药物医学这一科学医学学科和职业的发展，研究生职业教育与培训的演变与新药研发同步进行。在过去50年里，培养胜任工作的专业人员至关重要，与此同时，还需要应对研发技术、患者和医疗系统需求的快速复杂变化，以及药品整个生命周期开发过程中所适用的伦理和监管义务。从无组织的培训转向具有教学大纲、课程和认证评估的正规项目，这一转变伴随着教育向基于成果、以学习者为中心、基于能力的项目的变革。在药物医学专业从业者的57项核心能力发展的同时，教育与培训的演变在七个领域的能力框架中进行了描述：药物发现与早期开发；临床开发与临床试验；药品监管；药物安全与监测；伦理与受试者保护；医疗市场；沟通与管理。在本科、研究生和持续专业发展层面，将核心能力应用于药物开发的统一国际教育培训平台，将激发培养一支胜任的劳动力队伍的潜力，旨在为全球患者更快地提供更好、更合适的药物。
