CGMPs for Combination Products – Final Rule and Implementation

Regulatory Affairs Professionals Society (RAPS)5635 Fishers Lane, Suite 550
Rockville, MD 20852

Bradley Merrill Thompson, Member of the Firm, will speak at CGMPs for Combination Products - Final Rule and Implementation, hosted by the Regulatory Affairs Professionals Society (RAPS).

On 22 January 2013, the US Food and Drug Administration (FDA) issued the final rule on current Good Manufacturing Practices (CGMPs) for combination products. This highly anticipated rule is intended to clarify how the agency's GMP requirements apply to the manufacturing operations of combination products companies. While the final rule did not change significantly from the proposed rule, the agency indicated that many of the existing ambiguities will be clarified through guidance documents.

Offered in collaboration with the Combination Products Coalition (CPC), this program offers the unique opportunity to examine the contents of the final rule and the agency's implementation plan with representatives from FDA's Office of Combination Products and industry peers. You will hear directly from experts at each of the FDA centers and industry regarding what the final rule includes, with an emphasis on deviations from the proposed rule, as well as how the final rule may affect you and your company.

Working intensively in small groups facilitated by experts from CPC, you will use a case study approach to apply the final rule and analyze the rule's remaining ambiguities and identify approaches for effective implementation. You will then benefit from a final recap session during which the expert facilitators will present and connect major themes identified during the breakouts, allowing for organic discussions and problem solving by the group as a whole. Additionally, you will have the opportunity to provide feedback directly to the experts at the various centers responsible for developing the implementation guidance regarding any other ambiguities not addressed in the case studies. 

As well as the opportunity to provide feedback directly to FDA experts during the program, RAPS and CPC will collaborate to compile the major themes that emerge from the program regarding implementation and submit them as comments that FDA will consider when developing its guidelines for implementation. Don't miss your opportunity to provide your input on this pivotal issue.

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