News & Events
5th Product and Pipeline Enhancement for Generics Conference
Georgetown University Conference Center
Locke Lord is a proud sponsor of the 5th Product and Pipeline Enhancement for Generics Conference to be held on July 17-19, 2012 in Washington, DC.
Locke Lord Partner Kevin Nelson will present a case study on “Studying the Impact of the FDA’s guidance on Biosimilars for the Generics Industry to Ensure Regulatory Compliance.” The presentation will include:
- Understanding key elements of the FDA’s draft guidance and how it will affect companies looking to expand into biosimilars
- Implementing strategies to overcome specific patent challenges tied to producing the generic versions of biologics
- Addressing the data that will be required for generic companies’ biosimilars submissions to the FDA
- Identifying potential improvements to the guidance that have been submitted by the industry and how the guidance could change before becoming finalized
- Reviewing the guideline for when the guidance will be finalized and identifying the next steps for generic companies
For additional information and registration for the conference, please click here.