Using Legislation to Advance Regulatory Science: "I'm Just a Bill..."
Track
:
Track 10: Public Policy/ Health Care Compliance/ Law
Program Code:
313
Date:
Wednesday, June 26, 2013
Time:
8:00 AM to 9:30 AM
EST
Location:
154
CHAIR
:
Karen E. Jaffe, MBA,MS,MSc,RAC (SCHSUP), Life Sciences Professional, Alfred Mann Institute, United States
Over 25 year in technology, managed the Argus Suite of products and served as Director of Product Strategy for Oracle's Pharmacovigilance Analytics products. Completed Masters in Regulatory Science from USC School of Pharmacy, responsible for Regulatory & Clinical Affairs for Alfred Mann Institute.
SPEAKER
(S):
Juergen Froehlich, MD,MBA,FFPM (SPKNON), Vice President, Global Regulatory Affairs, Vertex Pharmaceuticals, United States
I am a successful leader in strategic planning and execution of all phases of drug development with a wide range of experience and knowledge across areas such as cardiovascular and cerebrovascular disease, endocrinology, immunology, oncology, neuromuscular disease and hematology/hemophilia
Marc M. Boutin, Esq, JD (SPKSUP), Executive Vice President and Chief Operating Officer, National Health Council, United States
Executive Vice President and Chief Operating Officer of the National Health Council, an organization that brings together all segments of the health care community to provide a united voice for the more than 133 million people with chronic diseases and disabilities and their family caregivers.
Carla Mann Woods, (SPKSUP), CEO and Founder, Fight to Live, United States
Steven Walker, (SPKSUP), Co-founder, Abigail Alliance, United States
His responsibilities include regulatory and legislative efforts, scientific direction, advocacy for patient’s rights, spokesperson for the alliance on regulatory and scientific issues, and author of papers, articles and editorials written to educate the public.
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.