(0)

Already a DIA Member? Sign in. Not a member? Join.

Sign in

Forgot User ID? or Forgot Password?

Not a Member?

Create Account and Join

Grand Hyatt Washington at Washington Center

Feb 20, 2013 8:00 AM - Feb 21, 2013 5:00 PM

1000 H Street, NW, , Washington, DC 20001-4310 , USA

Marketing Pharmaceuticals 2013: Workshop for Regulatory, Legal, Communications Professionals, and Promotional Review Teams

Back to Agenda

Fundamental Issues in the Regulatory Evaluation of Health Economic Information

Session Chair(s)

Philomena McArthur, JD

Philomena McArthur, JD

VP, Global Policies, Procedures & Training, Health Care Compliance & Privacy

Johnson & Johnson International, United States

This session will focus on the underlying issues with health economic analyses, what the methods are, what their strengths and weaknesses are from a substantiation perspective, and why these issues profoundly affect FDA policy in this area. This session will define the fundamental elements of HCEI, CER, RCTs, etc., and all of their respective relationships to the FDA substantial evidence standards.

Speaker(s)

Robert J. Matheis, PhD

Panelists

Robert J. Matheis, PhD

Celgene Corporation, United States

Executive Director, Global Scientific Communications

Meredith Manning, JD, MS

Panelists

Meredith Manning, JD, MS

Hogan Lovells, United States

Partner and Co-Director, Pharmaceutical and Biotechnology Practice Group

Harlan F. Weisman

Panelists

Harlan F. Weisman

And-One Consulting, LLC, United States

Managing Director

Have an account?

Be informed and stay engaged.

Don't miss an opportunity - join our mailing list to stay up to date on DIA insights and events.