Abstract
IFAPP (International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine) is a nonprofit organization with the mission to promote Pharmaceutical Medicine & Medicines Development (PM&MD) by enhancing the competencies and maintaining high research ethical standards of Pharmaceutical Physicians and other professionals involved in medicines development worldwide, leading to the availability and appropriate use of medicines for the benefit of patients and society1. About 30 national professional associations related to PM&MD, involving 7000 professionals, are affiliated to IFAPP. Medicines development has traditionally been a challenging enterprise, with high risk, high investment, and potentially high returns in the lengthy and complex process of identifying a new chemical entity as a candidate for development and possibly succeeding in bringing it as a pharmaceutical product to the market. However, the emergence of genomics, translational research, biomarkers, and precision medicine pose challenges going forward involving allocation of resources, price, market access, and cost-effectiveness as opposed to the traditional concepts of “efficacy” and “safety.” Education and Continuing Professional Development (CPD) are a major focus of IFAPP. The International Conference on Pharmaceutical Medicine (ICPM) is the largest event for our organization; ICPM is held every 2 or 3 years and is aimed to provide the state of the art in key areas for our discipline and profession. The paper is a reflection on the role of competency-based education and training for Pharmaceutical Physicians and medicines development scientists, as was discussed during the recent ICPM 2016 held in Sao Paulo, Brazil on April 18–19, with the support of the Brazilian Association of Pharmaceutical Medicine, and gathered around 200 representatives from the pharmaceutical, clinical research and regulatory arenas from all over the world2,3.
Highlights
Pharmaceutical medicine is defined by the Faculty of Pharmaceutical Medicine as “the medical scientific discipline concerned with the discovery, development, evaluation, registration, monitoring, and medical aspects of marketing of medicines for the benefit of patients and the health of the community4.”
The terms Pharmaceutical Physicians (PPs) and Medicines Development Scientists (MDS) refer to individuals with different academic backgrounds working in similar fields
Since the certification is granted by the profession, the appropriate professional certifying bodies would be IFAPP and PharmaTrain, and because of their global nature would provide the required international scope
Summary
Pharmaceutical medicine is defined by the Faculty of Pharmaceutical Medicine as “the medical scientific discipline concerned with the discovery, development, evaluation, registration, monitoring, and medical aspects of marketing of medicines for the benefit of patients and the health of the community4.”. The terms Pharmaceutical Physicians (PPs) and Medicines Development Scientists (MDS) refer to individuals with different academic backgrounds working in similar fields The latter term refers to experts who are not medically qualified, work in various fields of natural sciences, pharmacy, and medical device engineering, have adequate training in nonclinical and clinical aspects of medicines development and work as integrated members of clinical medicines development teams. “At core of the discipline is: the clinical testing of medicines, translation of pharmaceutical drug research into new medicines, safety and well-being of research participants in clinical trials, understanding the safety profile of medicines and their benefitrisk balance4.”. These are the core domains of Pharmaceutical Medicine and Medicines Development.
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