The Alliance for Clinical Research Excellence and Safety (ACRES), a Cambridge, Mass.-based global nonprofit, and PharmaTrain Federation, an international nonprofit organization for improving education and training of professionals in medicines development, have allied to promote the adoption of new and reliable global standards for high-quality postgraduate education and training for individuals pursuing careers in discovery, development, regulation and marketing of new medicines.

Dr. Greg Koski, president and CEO of ACRES, and Dr. Ingrid Klingmann, coordinator of PharmaTrain, said the goal of the partnership is to develop and implement a systems approach to addressing the many challenges currently facing global drug development and health-related research.

Proposed projects include the development and dissemination of curriculum standards for educational programs and the implementation of a global quality assessment and recognition process for educational programs and training courses, as part of the shared infrastructure necessary for the multi-stakeholder integration of education in medicines development.

 “PharmaTrain has defined 180 content topics in its comprehensive syllabus of medicines development and mapped them to 60 critical learning outcomes, which are aligned with the core competencies for scientists involved in medicines development,” said Koski. “This approach to standards-based education and training has been missing in preparing professionals in medicines development. Our alliance with PharmaTrain will facilitate the adoption and implementation of these standards worldwide with significant beneficial impact for the industry and for patients."

"PharmaTrain emerged as an education and training project within the European Innovative Medicines Initiative—it is now ready to undertake the next step for globalization," said Fritz Bühler, PharmaTrain’s founder, professor of pharmaceutical medicine and cardiology at the University of Basel and former head of global clinical R&D at Roche.

"To train a new generation of professionals in medicines development, a rigorous standardized but flexible curriculum is essential," said Klingmann, who also is chairman of the board of the European Forum for Good Clinical Practice (EFGCP). "Currently over 30 universities in Europe and North America have implemented the PharmaTrain curriculum—with ACRES, we intend to offer PharmaTrain to the world."