CBI’s FDA/CMS Summit draws the highest leadership at the FDA and CMS and delivers best available information on FDA and CMS priorities, policy changes, evidence-based practice, federal review processes on various areas of biopharma like CDER, CBER, CDRH and the most cutting-edge advances in healthcare and technology. This event is geared to the information needs of C-Suite biopharmaceutical executives, Directors/VPs of Regulatory/Government Affairs,
FDA regulators, consultants, law firms, PhRMA and big pharmaceutical companies.

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.