2012 RAPS Annual Conference: Combination Product Regulation for the US Market
Seattle, WA 98101-2350
Bradley Merrill Thompson, Member of the Firm, will copresent a pre-conference workshop, "Combination Product Regulation for the US Market," at the 2012 RAPS Annual Conference, which runs from October 26 to 30.
This workshop will analyze principles and concepts for regulation of combination products. Current guidance documents will be discussed and attendees will hear directly from representatives from FDA's Office of Combination Products.
Current information on good manufacturing practices, adverse event reporting, complex postapproval topics, and the impact of the EU MDD will also be presented. Take a deeper dive on the regulatory issues on pre-filled injectors and the issues surrounding the co-development of diagnostics and drugs used in personalized medicine. The day will close with a panel discussion and an opportunity to engage with the experts.
For more information and to register, visit RAPS.org.