Thursday, July 5, 2012

Business of Biosimilars & Generic Drugs Session Spotlight: Analyze the Regulatory Criteria that your Generic Drug Candidate Must Meet

Amidst all the focus on the Affordable Care Act, it is important to remember that there were other important new codes taking effect this year regarding the reimbursement and user fees for generic drugs. Candis Edwards, Senior Director for Regulatory Affairs and Compliance at Amneal Pharmaceuticals, will detail the best ways to account for new generic drug user fees in your business plan, as well as providing a timely update on factors that had changed concerning REMS agreements between branded and generic pharma companies.

Today, we highlight the session Analyze the Regulatory Criteria that your Generic Drug Candidate Must Meet presented by Candis Edwards, Senior Director, Regulatory Affairs & Compliance, Amneal Pharmaceuticals.  Business of Biosimilars and Generic Drugs will take place September 10-12, 2012, in Boston, MA.   For more information on the rest of the program, download the agenda.  If you'd like to join us in Boston, as a reader of this blog, register to join us and mention code XP1786BLOG and save 25% off the standard rate!

Featured Session: Analyze the Regulatory Criteria that your Generic Drug Candidate Must Meet
Featured Speaker: Candis Edwards, Senior Director, Regulatory Affairs & Compliance, Amneal Pharmaceuticals
About the Session: 2012 saw the installation of a new regime of user fees for sponsors of generic drug candidates. This timely session will analyze the impact that these changes will have on your business model and appropriate methods for making the best use of your regulatory interactions.
  • • Anticipate and account for new user fees in your business plan
  • • Itemize the differences between new user fee structure and earlier payment systems
  • • Update on important factors concerning REMS agreements between generic and brand companies

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