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参与药物研发的生物医学专业人员的能力、教育和培训需求的国际认知

International Perception of Competence, Education, and Training Needs Among Biomedical Professionals Involved in Medicines Development.

作者信息

Imamura Kyoko, Criscuolo Domenico, Jurczynska Anna, Kesselring Gustavo, Stonier Peter, Tsuda Tatsushi, Silva Honorio

机构信息

Social Cooperation Program of IT Healthcare, Graduate School of Pharmaceutical Sciences, The University of Tokyo, Tokyo, Japan.

Italian Association of Pharmaceutical Medicine (SIMeF), Milan, Italy.

出版信息

Front Pharmacol. 2019 Mar 5;10:188. doi: 10.3389/fphar.2019.00188. eCollection 2019.

DOI:10.3389/fphar.2019.00188
PMID:30890940
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6411843/
Abstract

The development of new medicines today, requires a multi-professional workforce, both in industry and the clinical research arena. Pharmaceutical physicians (PPs) and medicines development scientists (MDS) need a certain level of competence, achieved through on-the-job experience, with a postgraduate education foundation and continuous professional development programs. In order to assess the self-perception of competence, education and training needs, an on-line questionnaire based on the seven domains of competence, developed by IFAPP-PharmaTrain, was prepared and distributed among PPs and MDS members of IFAPP's affiliated professional associations in countries with facilities for postgraduate education. The data collection was run over a fixed period of three months in Japan, Italy, Brazil, and Spain during 2017. Results indicate low but variable levels of perceived competence for the various domains as well as seniority in the job. All respondents declared a significant need for continuing professional development in all domains. These results corroborate and support the continuous efforts, put in place by IFAPP and the PharmaTrain Federation, to foster the development of accredited education and training among professionals involved in medicines development.

摘要

如今,新药研发需要行业和临床研究领域的多专业人才队伍。制药医师(PPs)和药物研发科学家(MDS)需要具备一定水平的能力,这些能力通过在职经验、研究生教育基础以及持续专业发展项目来获得。为了评估能力、教育和培训需求的自我认知,基于国际药物政策与实践协会 - 药物培训(IFAPP - PharmaTrain)制定的七个能力领域编制了一份在线问卷,并分发给IFAPP附属专业协会中在有研究生教育设施的国家的PPs和MDS成员。2017年,在日本、意大利、巴西和西班牙进行了为期三个月的固定时间段的数据收集。结果表明,各个领域以及工作资历方面的感知能力水平较低且存在差异。所有受访者都表示在所有领域都非常需要持续专业发展。这些结果证实并支持了IFAPP和药物培训联合会为促进参与药物研发的专业人员的认可教育和培训发展所做的持续努力。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5a24/6411843/2186e2ada03f/fphar-10-00188-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5a24/6411843/0ee412c40dbf/fphar-10-00188-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5a24/6411843/2186e2ada03f/fphar-10-00188-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5a24/6411843/0ee412c40dbf/fphar-10-00188-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5a24/6411843/2186e2ada03f/fphar-10-00188-g002.jpg

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Front Pharmacol. 2016 Oct 14;7:377. doi: 10.3389/fphar.2016.00377. eCollection 2016.
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Assessing clinical investigators' perceptions of relevance and competency of clinical trials skills: An international AIDS Malignancy Consortium (AMC) study.
评估临床研究人员对临床试验技能相关性和胜任能力的认知:一项国际艾滋病恶性肿瘤联盟(AMC)的研究。
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The Specialist in Medicines Development (SMD) as a Vocational Program in Pharmaceutical Medicine: The Japanese and Italian Experience.作为药物医学职业项目的药物研发专家(SMD):日本和意大利的经验。
Front Pharmacol. 2020 Feb 25;11:62. doi: 10.3389/fphar.2020.00062. eCollection 2020.
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Nuts and bolts of entrustable professional activities.可托付专业活动的基本要素。
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