Other Industry Events

FDA/CMS Summit 2019

Arlington, VA

December 3–4, 2019

GARNER THE LATEST REGULATORY UPDATES AND PRIORITIES AND DISCUSS:

• Examine the strategic plans and priorities for CDER and
  the Office of New Drugs for 2019 and the year ahead
• Understand the evolving role of RWE and PROs in
  regulatory decision-making and drug development
• Explore shifts in the regulatory landscape for cell and
  gene therapies and next steps in removing barriers to
  access and reimbursement challenges
• Review the current state of streamlining the rare disease
  drug review pathway
• Consider the impact of the drug pricing debate on
  drug development pipeline decision-making
• Analyze how to further advance the science of patient input
  and the impact on regulatory decision-making and
  reimbursement models
• Assess evolving value-based payment models to address
  reimbursement challenges for rare disease drugs and
  advanced therapeutics
• Identify next steps to advance biosimilars adoption in the U.S.