Rockville, MD, USA—In the wake of the US Food and Drug Administration’s (FDA) recent release of its final rule on current Good Manufacturing Practices (CGMPs) for combination products, the Regulatory Affairs Professionals Society (RAPS) has collaborated with the Combination Products Coalition (CPC) to offer a workshop that will examine the rule and FDA’s plan for implementation. The workshop, CGMPs for Combination Products—Final Rule and Implementation: An Interactive Analysis With Industry and FDA, will take place 28 February, 11:00 am–4:00 pm EST, at the RAPS training center in Rockville, MD, USA, and also will be available online as a live webcast.
In its Federal Register posting on the final rule, FDA wrote that it “sets forth a transparent and streamlined regulatory framework for firms to use when demonstrating compliance with CGMP requirements for ‘single-entity’ and ‘co-packaged’ combination products.”
During this workshop, representatives from FDA’s Office of Combination Products and industry experts will discuss the contents of the final rule and how it differs from the proposed rule, as well the rule’s likely impact on industry and how to comply. Attendees will then work in small groups facilitated by experts from CPC, using case studies to apply the final rule, analyze ambiguities and identify approaches for effective implementation.
In the afternoon, experts from FDA’s Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research and Center for Devices and Radiologic Health will participate in an interactive panel discussion on implementation of the final rule. Attendees will be able to provide feedback and ask questions on additional topics not addressed during the case study exercise. Following the program, RAPS and CPC will summarize major themes that emerge from the workshop and submit comments to FDA that agency officials will consider when developing guidelines for implementation.
Registration for this workshop is currently open. Interested members of the media should contact RAPS Senior Manager of Communications Zachary Brousseau at firstname.lastname@example.org or +1 301 770 2920, ext. 245.
The Regulatory Affairs Professionals Society (RAPS) is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Founded in 1976, RAPS helped establish the regulatory profession and continues to actively support the professional and lead the profession as a neutral, non-lobbying nonprofit organization. RAPS offers education and training, professional standards, publications, research, knowledge sharing, networking, career development opportunities and other valuable resources, including Regulatory Affairs Certification (RAC), the only post-academic professional credential to recognize regulatory excellence. RAPS is headquartered in suburban Washington, DC, with offices in Europe and Asia, and chapters and affiliates worldwide. RAPS.org