Education and training for medicines development, regulation, and clinical research in emerging countries.
The aim of this satellite workshop held at the 17th World Congress of Basic and Clinical Pharmacology (WCP2014) was to discuss the needs, optimal methods and practical approaches for extending education and teaching of medicines development, regulation, and clinical research to Low and Middle Income Countries (LMICs). It was generally agreed that, for efficiently treating the rapidly growing number of patients suffering from non-communicable diseases, modern drug therapy has to become available more widely and with a shorter time lag in these countries. To achieve this goal many additional experts working in medicines development, regulation, and clinical research have to be trained in parallel. The competence-oriented educational programs designed within the framework of the European Innovative Medicine Initiative-PharmaTrain (IMI-PhT) project were developed with the purpose to cover these interconnected fields. In addition, the programs can be easily adapted to the various local needs, primarily due to their modular architecture and well defined learning outcomes. Furthermore, the program is accompanied by stringent quality assurance standards which are essential for providing internationally accepted certificates. Effective cooperation between international and local experts and organizations, the involvement of the industry, health care centers and governments is essential for successful education. The initiative should also support the development of professional networks able to manage complex health care strategies. In addition it should help establish cooperation between neighboring countries for jointly managing clinical trials, as well as complex regulatory and ethical issues.
Department of Pharmacology and Pharmacotherapy, Faculty of Medicine, Semmelweis University , Budapest, Hungary.
Sandor
S
Kerpel-Fronius
Division of Clinical Pharmacology, Faculty of Medicine and Health Sciences, Stellenbosch University , Cape Town, South Africa ; Fundisa African Academy of Medicines Development, Cape Town , South Africa.
Bernd
B
Rosenkranz
Division of Clinical Pharmacology, Department of Medicine, South African Faculty, Global Health Network, University of Cape Town , Cape Town, South Africa.
Elizabeth
E
Allen
University of Basel, Pharmaceutical Medicine , Basel, Switzerland.
Rolf
R
Bass
Ministry of Higher Education and Research, Institut National de la Santé et de la Recherche Médicale , Paris, France.
Jacques D
JD
Mainard
WHO Collaborating Centre for Advocacy and Training in Pharmacovigilance, Centre for Tropical Clinical Pharmacology and Therapeutics, University of Ghana Medical School , Accra, Ghana.
Alex
A
Dodoo
Postgraduate Programme in Pharmaceutical Medicine and Medicines Development Sciences, Université Libre de Bruxelles , Brussels, Belgium.
Dominique J
DJ
Dubois
Medicines Control Council, Pretoria , South Africa.
Mandisa
M
Hela
Quantitative Sciences, Bill & Melinda Gates Foundation , Seattle, WA, USA.
Steven
S
Kern
Education and Research Institute, Hospital Sirio-Libanes , Sao Paulo, Brazil.
Joao
J
Massud
BioPharma Educational Initiative, Rutgers University School of Health Related Professions , Newark, NJ, USA ; Inter American Foundation for Clinical Research , New York, NY, USA.
Honorio
H
Silva
School of Health Sciences, Hibernia College , Dublin, Ireland.
Jeremy
J
Whitty
clinical trials; competencies; learning outcomes; low and middle income countries; pharmaceutical medicine; regulatory agencies