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欧洲生物技术工业药学实践能力框架。

A European Competence Framework for Industrial Pharmacy Practice in Biotechnology.

作者信息

Atkinson Jeffrey, Crowley Pat, De Paepe Kristien, Gennery Brian, Koster Andries, Martini Luigi, Moffat Vivien, Nicholson Jane, Pauwels Gunther, Ronsisvalle Giuseppe, Sousa Vitor, van Schravendijk Chris, Wilson Keith

机构信息

Pharmacolor Consultants Nancy (pcn-consultants), 12 rue de Versigny, 54600 Villers, France.

Callum Consultancy, 571 Berwyn Baptist Road, Devon, PA 19333, USA.

出版信息

Pharmacy (Basel). 2015 Jul 29;3(3):101-128. doi: 10.3390/pharmacy3030101.

DOI:10.3390/pharmacy3030101
PMID:28975907
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5597173/
Abstract

The PHAR-IN ("") looked at whether there is a difference in how industrial employees and academics rank competences for practice in the biotechnological industry. A small expert panel consisting of the authors of this paper produced a biotechnology competence framework by drawing up an initial list of competences then ranking them in importance using a three-stage Delphi process. The framework was next evaluated and validated by a large expert panel of academics ( 37) and industrial employees ( = 154). Results show that priorities for industrial employees and academics were similar. The competences for biotechnology practice that received the highest scores were mainly in: "Research and Development", '"Upstream" and "Downstream" Processing', "Product development and formulation", "Aseptic processing", "Analytical methodology", "Product stability", and "Regulation". The main area of disagreement was in the category "Ethics and drug safety" where academics ranked competences higher than did industrial employees.

摘要

PHAR-IN("")研究了产业员工和学术界人士对生物技术行业实践能力的排名是否存在差异。由本文作者组成的一个小型专家小组通过拟定一份能力初始清单,然后使用三阶段德尔菲法对其重要性进行排名,制定了一个生物技术能力框架。接下来,一个由37名学术界人士和154名产业员工组成的大型专家小组对该框架进行了评估和验证。结果表明,产业员工和学术界人士的优先事项相似。在生物技术实践中得分最高的能力主要集中在:“研发”、“上游”和“下游”加工、“产品开发与配方”、“无菌加工”、“分析方法”、“产品稳定性”和“监管”。主要的分歧领域在于“伦理与药物安全”类别,学术界人士对该类别能力的排名高于产业员工。

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本文引用的文献

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Nationwide collaborative development of learning outcomes and exemplar standards for Australian pharmacy programmes.澳大利亚药学课程学习成果与范例标准的全国性合作开发。
Int J Pharm Pract. 2015 Aug;23(4):283-291. doi: 10.1111/ijpp.12163. Epub 2014 Nov 13.
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Tuning research competences for Bologna three cycles in medicine: report of a MEDINE2 European consensus survey.调整医学博洛尼亚三周期的研究能力:MEDINE2 欧洲共识调查的报告。
Perspect Med Educ. 2013 Sep;2(4):181-195. doi: 10.1007/s40037-013-0066-z.
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Am J Pharm Educ. 2013 May 13;77(4):S2. doi: 10.5688/ajpe774S2.
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Eur J Pharm Sci. 2011 Oct 9;44(3):437-40. doi: 10.1016/j.ejps.2011.07.008. Epub 2011 Jul 18.
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