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December 11-12, 2018
The Westin Washington, D.C. City Center,
Washington, D.C.

IMMERSE YOURSELF IN THE LATEST US REGULATORY POLICY AT THIS CRITICAL TIME IN SCIENTIFIC INNOVATION

Connect with FDA, CMS, and CDRH Leaders, and Industry Peers to Discuss How Regulatory Changes Will Impact You, Your Organization, and the Biopharma Industry

NEW SPEAKER ADDITION

Eric Hargan, Deputy Secretary of HHS has just been confirmed to present a status update on the administration’s HHS pricing blueprint

Join discussions on the regulatory focus Post Mid-Term Elections

Hear Updates from the FDA Offices of:
  • Safety, Efficacy and Post Market Surveillance
  • CDER
  • Office of New Drugs
  • Rare Diseases Program
  • CDRH
A full range of topics to be covered include:
  • Changes in the Political Landscape Impacting Pharma and Bio Regulations
  • Delivering Gene Therapies: A New Era in Medicine
  • The Role of Value Based Reimbursement and Value Based Outcomes 
  • Burden of Proof: Building a Value Framework for Regulatory and Payer Approval
Share perspectives on timely politicized movements:
  • Hear the status of the Biosimilar Action Plan recent effort and template to expedite approval of biosimilars
  • RWE In Drug Approval Process
  • Addressing the Opioid Epidemic
  • Expanded access and Right to Try

FDA/CMS SUMMIT SPEAKER Q&As


KNect365 recently consulted with several FDA/CMS Summit speakers to share their expertise on recent developments in federal drug regulations, industry changes and the resulting and direct impact on their work.

The answers we were able to gather provide insights on industry shifts and regulation policies we can expect in the near future and how these changes impact stakeholders and processes.

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