Research Topic

Grand Challenges in Pharmaceutical Medicine: Competencies and Ethics in Medicines Development

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Please note that all submissions to this Research Topic must have been invited to be considered for review. Any submissions which do not fulfill this criterion will not be so considered.

The emergence of competency based education, based upon competencies and entrustable Professional Activities, has ...

Please note that all submissions to this Research Topic must have been invited to be considered for review. Any submissions which do not fulfill this criterion will not be so considered.

The emergence of competency based education, based upon competencies and entrustable Professional Activities, has induced a disruptive transformation of the post-graduation and training in Pharmaceutical Medicine and Medicines development.

There is a perceived mismatch between the profile of the graduates from academic programs in health care professions and the changing needs of the various health systems around the world. Professional education has not kept pace with these changes, particularly in the areas related to medicines development.

Recent scientific development extended the concept of medical products with several new products including biological agents, gene and cell therapies as well as medicine-medical device combinations. The development and application of these new products can be efficiently done only in complex, multidisciplinary teams combining the know-how of clinicians, basic scientists and engineers.

The joint ethical responsibilities of all the medically and non-medically qualified members of such complex teams must be addressed in order to guarantee their harmonized and ethical functioning. In addition, both modern developers and medical practitioners have to deal with novel ethical issues related to the use of new gene, cell and immune therapies which might “reengineer” the human body life-long, with the nature of these late changes remaining unknown at present.

A perceived need for further granulation in medicines development led to various professional groups worldwide to produce specific competencies for the areas of clinical research, safety sciences, regulatory sciences, etc. As a result the concept of inter-professional education based upon shared competencies is emerging as a clear need for the effective development of medicines and bringing value to the health care system in both the developed and emerging world. The definition of competencies, entrustable professional activities and the supportive ethics frame work are a critical component to make it happen.

Thus, the objective of this Research Topic is to generate a collaborative discussion on the future direction of Pharmaceutical Medicine training and education, based on the definitions of core competencies in Pharmaceutical Medicine and Medicines Development.

IN MEMORIAM: This Research Topic is dedicated to Fritz R. Bühler, Professor of Pharmaceutical Medicine, who sadly passed away at the age of 77 years.

Fritz Bühler was a visionary in creating professional standards in Pharmaceutical Medicine and Medicines Development. He envisioned and stimulated the development of professional competencies to guide educational programs and define job profiles. He inspired the development of a global statement of competence in our profession.

His commitment to foster training and promotion of young people was highly commendable. Via his excellent global network, Fritz Bühler supported the creation of educational programs in Europe, as well as in the USA and China. His exceptional talent would be a model to bring together people and knowledge, and further exploring new horizons in our discipline.

To compliment the scope of the project set out above, the following publications are especially relevant:

Silva H et al. (2013) Core competencies for pharmaceutical physicians and drug development scientists. Front.Pharmacol. 4:105. doi:10.3389/ fphar.2013.00105

Kerpel-Fronius S et al. (2015) Education and training for medicines development, regulation, and clinical research in emerging countries. Front. Pharmacol. 6:80. doi: 10.3389/fphar.2015.00080

Boeynaems J-M et al. (2013) A European approach to clinical investigator training. Front.Pharmacol. 4:112. doi:10.3389/fphar.2013.00112

Dubois DJ et al. (2016) Fostering Competence in Medicines Development: The IFAPP Perspective. Front. Pharmacol. 7:377. doi: 10.3389/fphar.2016.00377-


Keywords: Inter-professional education, Pharmaceutical Medicine, Novel ethical issues, Pharmaceutical Medicine training and education needs, Definitions of core competencies in Pharmaceutical Medicine and Medicines Development, Clinical research competencies, Medical affairs competencies, Regulatory affairs competencies, Drug safety competencies, Readership in medicines development, Emerging ethical issues, Pharmaceutical physician, Medicines development scientist, Multidisciplinary clinical drug development, Ethics of multidisciplinary drug development teams


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