Core competencies for pharmaceutical physicians and drug development scientists

Silva, Honorio; Stonier, Peter D.; Bühler, Fritz R.; Deslypère, J.P.; Criscuolo, Domenico; Nell, Gerfried; Massud, Joao; Geary, Stewart; Schenk, Johanna; Kerpel‐Fronius, S.; Koski, Greg; Clemens, Norbert; Klingmann, Ingrid; Kesselring, Gustavo; Olden, Rudolf van; Dubois, Dominique

doi:10.3389/fphar.2013.00105

Cited by 43 publications

(42 citation statements)

References 21 publications

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“…The objectives were to define a set of core competencies for pharmaceutical physicians and drug development scientists, which would be summarized in a statement of competence. As a result, three areas, seven domains, and 57 core competencies were identified [30]. The PharmaTrain-IFAPP statement of competence is shown in Fig.…”

Section: Alignment Of Competencies In Medicines Developmentmentioning

confidence: 99%

“…As mentioned elsewhere, PharmaTrain, supported by the EU commission and the European Federation of Pharmaceutical Industries and Associations (EFPIA), has developed a standardized syllabus, curriculum, and multiple course programs for medicines development and is about to implement a professional qualification, the PharmaTrain Specialist in Medicines Development (SMD). The SMD is a competency-based, workplacecentred 4-year E&T program in medicines development, comprising a knowledge base covering the PharmaTrain syllabus for medicines development, delivered and assessed through modular curricula and the acquisition and demonstration of competencies for medicines development across seven domains [30]. Participants in this mentored program will become competent within a framework of assessment, appraisal, and annual review of progress and achievement.…”

Section: Competencies For Inter-professional Educationmentioning

confidence: 99%

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

et al. 2015

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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.

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Section: Alignment Of Competencies In Medicines Developmentmentioning

confidence: 99%

Section: Competencies For Inter-professional Educationmentioning

confidence: 99%

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

et al. 2015

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“…Twenty eight IFAPP member associations when surveyed showed that only 20% of their membership had received postgraduate education in pharmaceutical medicine (Silva et al, 2012(Silva et al, , 2013. Similarly, surveys conducted in the United States among pharmaceutical physicians revealed that the respondents lacked formal training in critical areas of drug development (Stonier et al, 2011).…”

Section: Development Of Core Competencies In Pharmaceutical Medicinementioning

confidence: 99%

Evolution of the Development of Core Competencies in Pharmaceutical Medicine and Their Potential Use in Education and Training

et al. 2020

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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.

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“…However, there are ongoing moves to address key stakeholder concerns particularly regarding the promotion of new medicines [85][86][87]. This includes improving the core competencies and standards of pharmaceutical physicians [88,89]. In addition, educating physicians that patients enrolled into clinical trials may be different to those seen in routine clinical care, which can mean additional vigilance [3,90].…”

Section: Ongoing Developments Impacting On the Role Of Hta To Improvementioning

confidence: 99%

Role of Health Technology Assessment in Pharmaceutical Market Access in Developed Countries

Kahveci¹,

Oortwijn²,

Godman³

et al. 2018

Pharmaceutical Market Access in Developed Markets2018

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Core competencies for pharmaceutical physicians and drug development scientists

Cited by 43 publications

References 21 publications

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

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

Evolution of the Development of Core Competencies in Pharmaceutical Medicine and Their Potential Use in Education and Training

Role of Health Technology Assessment in Pharmaceutical Market Access in Developed Countries

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