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December 5-6, 2017
Renaissance Washington DC Downtown,
Washington, D.C.

Connect with Federal Agencies for Regulatory Updates, Policies and Initiatives Impacting BioPharma

Discuss Current Trends & Developments with Industry Stakeholders and Hear What’s in the Pipeline for the Year Ahead

Save $500!

Register by July 28, 2017 and save $500 off the standard industry rate!

Get latest information on CDER, biosimilars, and PROs directly from decision-makers

Know What's Coming Down the Pipeline

Hear directly from CDER on goals, trends, and new drug development for 2017 and beyond.

Biosimilars Implication

Understand the economics and impacts of biosimilars on healthcare through global case studies.

The Evolving Role of PROs

Understand the implication of a more vocal patient role in drug development and feedback through a panel of patient advocacy groups and industry and FDA leaders.

Speak at FDA/CMS Summit 2017

We are now accepting proposals for this year's event. Submit your abstract on the following topics:

  • Understanding the Emerging Role of Patient Reported Outcomes (PRO) and FDA Use in Drug Programs
  • The Opportunities and Challenges of Expanded Access: Right to Try
  • The Pricing Issue in Pharma, Transparency, and Tying Value to Price Via Regulatory Oversight
  • Looking Globally at The Economics and Impact of Biosimilars on Healthcare in Other Parts of the World
  • Rare Tropical Diseases and Outbreaks: Addressing Pandemics, The Latest in Infrastructure Preparedness, and Accelerating Turnaround Time for Treatment and Eradication
  • Addressing the Logistical Challenges of Gaining Accelerated Approval
  • Manufacturers Panel: Addressing the Logistical Challenges of Gaining Accelerated Approval
  • Repurposing orphan drugs
  • Fast Track vs Breakthrough Therapy Designation
  • Current trends/developments in Biopharma approvals

Email Nicole Hayes with your proposal by July 14, 2017.

Media Partners

Sponsor the 2017 Event