ReGARDD Regional Regulatory Forum
Another component of ReGARDD is the Regional Regulatory Forum comprised of regulatory experts from the seven institutions involved in the project. The role of the forum is to strengthen the regulatory science workforce at each institution by providing exposure to a broad array of regulatory knowledge and by providing a platform to share best practices, discuss complex regulatory issues and consider ways to benefit from our collective regulatory expertise. This collaboration allows each center to take advantage of expertise spread across several CTSA institutions and to reduce duplication, increase efficiencies, and allow expertise to grow at each site by learning from one another.
The ReGARDD forum held its first meeting September 2016 with future meetings planned quarterly, rotating the location of the meeting between the seven institutions (RTI, UNC, Duke, MUSC, Wake Forest, VCU, and U Miami). Some forum meetings involve educational presentations for the regulatory personnel in attendance (e.g., electronic submissions to FDA, IND or IDE Training) and are open to the public. Other forum meetings are restricted to ReGARDD members to allow for confidential discussion of research projects with complex regulatory issues. Outside experts from Industry, the FDA or Research Triangle Park may also be invited to present to the forum or to address complex regulatory issues.
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