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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 to Learn How Regulatory Changes Will Impact You, Your Organization, and the Biopharma Industry

Book now to SAVE

Register by November 2 and save $100 off the industry rate!

Hear the regulatory focus Post Mid-Term Elections

Updates from the FDA Offices of:
  • Safety, Efficacy and Post Market Surveillance
  • CDER
  • Office of New Drugs
  • Rare Diseases Program
Biosimilar Action Plan
  • Hear the status of the recent effort and template to expedite approval of biosimilars
  • Evaluate the economics, impact, and FDA considerations in biosimilar competition, labeling, manufacturing, and approval
  • Competitor role in biologics, biosimilars and innovation
The Path Forward for Real-World Evidence
  • Identify the value of PROs
  • Learn the importance of communicating the rationale as to why a specific action/therapy or product represents good value
  • Understand the evolving role of the patient voice in drug development through a panel of advocates and industry and FDA leaders

FDA/CMS SUMMIT SPEAKER Q&As


We asked our speakers to share their expertise on recent developments in federal drug regulations, industry changes, and the resulting impact on their work.

Hear from the experts about what industry shifts and regulation policies we can expect in the near future and how these will affect the decisions and the way things are done.

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