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
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 brings together the best minds in US regulatory policy and scientific innovation
Hear from outstanding industry leaders including:
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.
Become our event partner
To discuss how your company can get involved, please contact Michael Moriarty
T: 646-895-7412, E: Michael.Moriarty@knect365.com