Andrew Weekes, Matthew Britland, Cathey Saha, Simon McErlane, Niloufar Ansari, Daniel Thurley, Victoria Elegant, Orin Chisholm
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引用次数: 0
Abstract
Background and objectives: Medical Affairs (MA) plays a critical role in bridging the gap between research, clinical practice and business strategy. With the rapid growth in this field, it is essential to have a competency framework to support individuals' professional development. A well-defined competency framework will not only empower MA professionals to excel and develop in their roles but also contribute to better patient outcomes and improved stakeholder engagement. This paper discusses the development of a competency framework for Medical Affairs professionals in Australasia.
Methods: The MA competency framework was developed using an iterative method by a team of MA professionals across Australia through a series of workshops and surveys over 2 years with the cooperation of the local MA community. The core development team debated and finessed the final framework over this time via meetings and discussions to arrive at the draft framework. This was pilot tested by a local pharmaceutical organisation and feedback informed some minor changes to the final framework. This was then endorsed by the Medical Affairs of Australasia (MAPA) Executive Committee.
Results: The framework consists of six domains: Scientific/Technical Knowledge, Evidence Generation, Compliance, Governance and Ethics, Leadership/Professionalism, Communication and Collaboration and Business Acumen, each with specific competencies and across four clearly defined levels from novice to expert.
Conclusion: This framework has been endorsed by the Medical Affairs Professionals of Australasia Executive Committee and provides a clear framework for the professional development of medical affairs professionals across our region. It is also applicable to MA professionals more broadly.
期刊介绍：
Pharmaceutical Medicine is a specialist discipline concerned with medical aspects of the discovery, development, evaluation, registration, regulation, monitoring, marketing, distribution and pricing of medicines, drug-device and drug-diagnostic combinations. The Journal disseminates information to support the community of professionals working in these highly inter-related functions. Key areas include translational medicine, clinical trial design, pharmacovigilance, clinical toxicology, drug regulation, clinical pharmacology, biostatistics and pharmacoeconomics. The Journal includes:Overviews of contentious or emerging issues.Comprehensive narrative reviews that provide an authoritative source of information on topical issues.Systematic reviews that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by PRISMA statement.Original research articles reporting the results of well-designed studies with a strong link to wider areas of clinical research.Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Pharmaceutical Medicine may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.All manuscripts are subject to peer review by international experts. Letters to the Editor are welcomed and will be considered for publication.
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