CENTERS OF EXCELLENCE (CoEs) FOR REGULATORY SCIENCE
The RHSC vision for the Centers of Excellence for Regulatory Science (CoEs) is to implement a sustainable platform for promoting regulatory convergence, capacity building and cooperation in topic areas relevant to medical product regulation.
The objectives of the CoEs are:
- To build human capacity in regulatory sciences that will bring quality medical products to patients as rapidly as possible;
- To promote dialogue that leads to the sharing of science and best practices;
- To achieve a model of sustainable operation that includes regulatory relevancy of materials and ensures continued value to all participants; and
- To leverage on existing work that has a level of convergence
This is achieved through the provision of high quality training programs through partnerships with academia, regulators and industry. Curriculum and training programmes are developed by the CoE with guidance from the PWA CoE Program Committee and in line with the PWA roadmap. The RHSC provides overall oversight and periodic assessments necessary to ensure that performance of the CoEs are in line with APEC objectives.
HOSTING INSTITUTIONS FOR A COE
CoEs are hosted and managed by universities, colleges, research centers, regulatory authorities or educational organizations that supply faculty, staff and material support.
If your institution is interested in becoming a CoE, please approach the CoE Coalition Co-Chair, Dr Jared Auclair.
STEPS TO BECOMING A COE
- Trusted global educational/regulatory/science-setting organizations
- Ability to develop and deliver training program against priorities set by the APEC RHSC
- Willingness to provide a full or part-time Director and appropriate staff to manage the CoE
- Ability & commitment to achieve objectives as agreed in operating guidelines
- Ability to fund the administrative overhead over the life of the agreement (minimum 5 years)
- Credibility in the topic area
- Location that provides easy access by participants
- Ability to provide qualified faculty; this could be visiting regulatory staff or other experts as required by the training program
- Ability to receive funding to support specific aspects of CoE training (for instance, to fund student travel)