Article 2015

Alignment of Competencies to Address Inefficiencies in Medicines Development and Clinical Research: Need for Inter-Professional Education

Pharmaceutical Medicine
Journal · Vol. 29 · Issue 3 · pp. 131-140
Abstract

The challenges faced by the biopharmaceutical industry in its key role to overcome the bottlenecks in innovative medicines development are related to addressing the technical knowledge gaps, the limitations to clinical trial testing, and the lack of clarity in the global pathways and processes to efficient outcomes. It is postulated that the lack of an adequately sized and appropriately trained multi-professional workforce, both in the industry and in the clinical research field, to enable fulfillment of the demanding aims for medicines development is a significant part of the problem. The current global status of pharmaceutical medicine’s efforts to conduct education and training is seen as patchy, inadequate, and without recognition, direction or leadership. It is therefore proposed that the movement towards competency-based education (CBE) should be harnessed, and core competency job and role profiles and competency curricula should be developed. CBE presents a means of addressing the educational and training needs within medicines development, harmonizing the workforce and the requirement for increased inter-professional teamwork. An educational environment in which aspiring and established biomedical professionals could readily learn about the competencies they need to pursue a particular career path is envisioned. Utilizing competencies provides the building blocks to align and harmonize the desired learning outcomes for effective performance amongst a multi-professional workforce. The effective implementation of training programs as described here has the potential to transform drug development procedures into an efficient and integrated process; medical product life-cycle management would result in the availability of better and safer medicines more rapidly, for the benefit of patients and society. © 2015, Springer International Publishing Switzerland.

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Index Keywords

clinical competence human medical education Article Vocational education curriculum United States leadership health care personnel Curriculum development community responsibility Europe clinical research drug development priority journal allied health education South and Central America
Author Affiliations
Faculty of Pharmaceutical Medicine, Royal College of Physicians, London, London, United Kingdom, Institute of Pharmaceutical Science, King's College London, London, United Kingdom
Rutgers School of Health Professions, Newark, NJ, United States, Alliance for Clinical Research Excellence and Safety (ACRES), Boston, MA, United States
Clinical Research Administration Program, Eastern Michigan University, Ypsilanti, MI, United States
Université Libre de Bruxelles, Brussels, BRU, Belgium
Rutgers School of Health Professions, Newark, NJ, United States
College of Nursing, The Ohio State University, Columbus, OH, United States
PharmaTrain Certification Board, Milan, Italy
Association of Clinical Research Professionals, Alexandria, VA, United States
Vision Institute, Sao Paulo, SP, Brazil, International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine, Woerden, Netherlands
Medizinische Universität Wien, Vienna, Vienna, Austria, PharmaTrain Federation, Brussels, Belgium
PharmaTrain Federation, Brussels, Belgium, European Forum for Good Clinical Practice, Brussels, Belgium
Funding & Acknowledgements
No funding information
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