Kerpel-Fronius Sandor, Rosenkranz Bernd, Allen Elizabeth, Bass Rolf, Mainard Jacques D, Dodoo Alex, Dubois Dominique J, Hela Mandisa, Kern Steven, Massud Joao, Silva Honorio, Whitty Jeremy
Department of Pharmacology and Pharmacotherapy, Faculty of Medicine, Semmelweis University , Budapest, Hungary.
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.
Front Pharmacol. 2015 Apr 14;6:80. doi: 10.3389/fphar.2015.00080. eCollection 2015.
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.
本次卫星会议在第17届世界基础与临床药理学大会（WCP2014）期间召开，其目的是探讨将药物研发、监管及临床研究的教育与教学拓展至低收入和中等收入国家（LMICs）的需求、最佳方法及实用途径。与会者普遍认为，为有效治疗日益增多的非传染性疾病患者，现代药物疗法必须在这些国家更广泛地普及，且缩短滞后时间。为实现这一目标，必须同步培养更多从事药物研发、监管及临床研究的专家。欧洲创新药物计划 - 制药培训（IMI - PhT）项目框架内设计的以能力为导向的教育项目，旨在涵盖这些相互关联的领域。此外，这些项目因其模块化架构和明确的学习成果，能够轻松适应各地的不同需求。再者，该项目还伴有严格的质量保证标准，这对于提供国际认可的证书至关重要。国际和当地专家及组织之间的有效合作、行业、医疗保健中心及政府的参与，对于成功开展教育至关重要。该倡议还应支持发展能够管理复杂医疗保健策略的专业网络。此外，它应有助于邻国之间建立合作，共同管理临床试验以及复杂的监管和伦理问题。
