Skip navigation

Your Window into Emerging FDA and CMS Regulatory Policies Affecting Life Sciences

December 3-4, 2019
  • Arlington, VA

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.

FDA/CMS Summit 2019

Your Window into Emerging FDA and CMS Regulatory Policies Affecting Life Sciences

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.