Agenda Posted

The opening sessions of the 7th Annual Post-Approval Summit will cover considerations of and an overview on the current post-approval landscape. The keynote presentation will provide an overview of the status and the impact of significant post-approval initiatives and changes at the Food and Drug Administration (FDA) over the past three years. Following the keynote presentation, an industry perspective will be given on how post-approval planning considerations are changing approaches to and decision making in product development, including:

• Earlier stakeholder engagement
• Integrating post-approval questions into product development studies
• Addressing demands for real-world data beyond randomized clinical trials (RCTs)
• The impact of these requirements on the already increasing costs for product development
• How decisions regarding new products may be altered by post-market realities

The Summit focuses on strategies and best practices for improving the safety, effectiveness, value and quality of healthcare products and services through post-approval studies. Please visit the Summit website at www.postapproval.org to view the full agenda with confirmed speakers.

Register Today!
Register online at www.postapproval.org. Register by March 11 and save $300! Registration before March 11 is $1,495, after March 11 is $1,795 and each additional registrant is $1,395. Your registration includes all conference materials, breakfast and lunch on both days and admittance to the opening night reception at Boston's Skywalk Observatory.

We look forward to seeing you in May!

Best Regards,

The Committee for the Post-Approval Summit
201 Broadway, Cambridge, MA 02139
Tel: (617) 621-6426
Fax: (617) 621-1620
mailto: postapproval@postapproval.org