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
Get latest information from the FDA on advanced therapeutics, Office of New Drugs, post-market surveillance, and more.
This event will cover timely politicized movements. A full range of topics to be discussed include:
Post Mid-Term Elections
Hear directly from CDER on goals, trends, and new drug development for 2019 and beyond.
Biosimilar Action Plan
Evaluate the economics, impact, and FDA considerations in biosimilar competition, labeling, manufacturing, and approval.
The Path Forward for Real-World Evidence
Understand the evolving role of the patient voice in drug development through a panel of advocates and industry and FDA leaders.
FDA/CMS Summit brings together the best minds in US regulatory policy and scientific innovation
Hear from outstanding industry leaders including:
I would like to thank the whole event team for putting together this conference. Conferences are made by its participants and the group assembled here today is so diverse and truly experienced.
Mark McClellan, MD/PhD
Former FDA Commissioner and CMS Administrator
Summit provided a rare opportunity for a broad group of life science companies and regulators to interact in a frank, yet cooperative manner. Great opportunity to learn from peers and our FDA / CMS customer.
David McNinch
Sr. Director of Marketing
Affymax
Nobody does it better!!! Best healthcare business policy conference of the year.
John Kamp
Executive Director
Coalition for Healthcare Communication
FDA/CMS Speaker Q&A's
We asked our speakers to share their expertise on recent developments in federal drug regulations, industry changes, and the resulting impact on their work.