WHEN: Monday, Nov. 16, 8:30 a.m. to 4:30 p.m.
WHERE: University of Maryland School of Law 500 W. Baltimore St. Baltimore, MD 21201
WHO: Keynote speakers: Andrew von Eschenbach, MD, former Food and Drug Administration (FDA) commissionerJeffrey Senger, JD, FDA deputy chief counselAlso, legal and pharmaceutical experts from government, industry, and academia
The conference will focus on the possible impact of ongoing changes at the FDA, in the food and drug industries, and in the policy debates that will shape law and regulation for decades to come. For agenda: http://www.law.umaryland.edu/faculty/conferences/detail.html?conf=80
Keynote speakers: Andrew C. von Eschenbach, former FDA Commissioner, and Jeffrey M. Senger, Esq., current FDA Deputy Chief CounselLeading legal and pharmacy experts will converge to speculate on hot topics, including: • Debate over the fallout for medical devices and drug labeling from two new, controversial Supreme Court decisions: Riegel v. Medtronic, Inc., that certain regulations bar state common-law claims challenging the effectiveness or safety of a medical device marketed as it was approved, premarket, from FDA.. Wyeth v. Levine, that Federal regulatory approval of a drug does not shield the manufacturer from liability under state law. • Will Congress, after eight years of debate, finally pass a law to regulate follow-on biologics--biotechnology therapies made from living cells, such as a vaccine or an antibodies? Regulating would be biologic therapies is more complicated than for the generic versions of small-molecule, or chemical, drugs. While chemical drugs can be copied exactly into generic versions, biologics cannot. But generic manufacturers worry that without a shortened process to make biosimilars, the new generics will be as expensive as the originals — and of little marketable value. Biotechnology companies take the opposite view. They want lengthy patent protections and strict. Each side has poured millions into Congressional lobbying campaigns. • An airing of how the FDA's use of the Risk Evaluation & Mitigation Strategies, REMS, was intended to usher in a new era of drug safety and post-market drug surveillance, but instead has caused substantial debate. • There will be a 4:30 p.m. Networking Reception for Speakers & AttendeesSponsored by the University of Maryland School of Law, Whiteford, Taylor & Preston, LLC, Greenleaf Health LLC, and The University of Maryland Center on Drugs and Public Policy.
Register on line: http://www.acteva.com/booking.cfm?bevaid=190473
RSS