The Global Coalition for Regulatory Science Research (GCRSR) officially established a Cross-Training Working Group (CTWG) in 2017. The focus of the CTWG is to establish a group of knowledgeable contributors interested in regulatory science training (science experts, collaborators, and managers) to harmonize training in research methodologies, laboratory support, and other relevant disciplinary components of regulatory science including new and emerging areas of science. The CTWG will use the official FDA definition to describe Regulatory Science as the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products. In the context of the CTWG, training will include any in-person and virtual training courses, workshops, fellowships, conferences, symposia and resources (books, PDFs, videos, etc.) designed for personnel working in the field of regulatory science. The CTWG is made up of lead representative(s) delegated by each participating member of the GCRSR.
- Establish an international network to enable partner-driven discussion about advancing regulatory science through sharing of relevant training opportunities and common practices;
- Identify the current laboratory and personnel training needs of the respective organization(s) of GCRSR;
- Compile currently available resources (e.g. training opportunities, workshops, etc.) under specific Food/Drug/Science Technology themes that Working Group members can offer to other countries;
- Conduct a gap analysis to characterize the current research needs, scientific questions and harmonization efforts for regulatory science personnel, and identify specific topics of regulatory science that can potentially be addressed by the Working Group;
- Create an open and accessible catalogue of research and training opportunities to strengthen personnel training and promote a shared understanding of personnel training;
- Facilitate discussions between interested parties to develop strategic personnel exchanges for competency development and capacity building; and
- Produce an annual report to the GCRSR Executive Committee on the progress and lessons learned from the activities of the CTWG