Using Legislation to Advance Regulatory Science: "I'm Just a Bill..."

Track:
Public Policy/ Health Care Compliance/ Law

Day & Time:
June 26, 8:00AM - 9:30AM

Session Number:
313

Room Number:
154

Level:
Intermediate

Type:
Session

Title:
Using Legislation to Advance Regulatory Science: "I'm Just a Bill..."

Chair(s):
Karen E. Jaffe, MBA,MS,MSc,RAC
Regulatory Research
Alfred Mann Institute, United States

Description:
Several legislations have been introduced calling for regulatory reform for the drug approval process. FDA is under pressure from industry to enable a regulatory framework for translational medicine but at the same time preserve the public health. This session will discuss impacts to the pharmaceutical industry and investment community as well as the patient community.

Learning Objective(s):
Discuss the issues surrounding introducing legislation; Describe the relationship between legislation and the implementation of regulatory modification; Discuss the impact of legislation on the various stakeholders in the drug development process.

Presentation(s) & Speaker(s):
Panelist
Juergen Froehlich, MD,MBA,FFPM
Vice President, Global Regulatory Affairs
Vertex Pharmaceuticals, United States

Panelist
Marc M. Boutin, JD
Executive Vice President and Chief Operating Officer
National Health Council, United States

Panelist
Steven Walker
Co-founder
Abigail Alliance, United States

Panelist
Carla Mann Woods
CEO and Founder
Fight to Live , United States