The University of Maryland Francis King Carey School of Law’s Law & Health Care Program and Student Health Law Organization and the School of Pharmacy’s Center for Drugs and Public Policy, in collaboration with the Washington, DC law firm, Arnold & Porter LLP, recently announced a conference to be held this April.
Entitled, “Emerging Issues in Food and Drug Law: Implementation of FDASIA,” this day long, free conference, will cover a number of important topics in the food and drug law world, with a particular focus on the recently enacted Food and Drug Administration Safety and Innovation Act (FDASIA), which we wrote about this past summer. The conference will be held at Arnold & Porter’s Washington, DC office on Wednesday, April 17, 2013.
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The timing of this conference will be just over nine months after the enactment of FDASIA and follows the more recent spotlight on FDA involvement in drug shortages and its regulation of pharmacy compounding. More recently, FDA announced its FDASIA timeline. The day-long conference includes panels on the following topics:
- Innovative Drug Approval
- Medical Device Regulatory Improvements
- The User Fee Acts: Updates on Implementation; and
- Hot Topics Panel (e.g., drug shortages, compounding)
A number of important FDA officials and legal stakeholders in the FDA world including:
- Keynote Speaker Leslie Kux, JD, Assistant Commissioner for Policy, FDA
- Representatives from FDA’s Center for Drug Evaluation and Research (CDER), including Patric Frey, MPP, Office of Planning and Analysis
- A Representative from the Center for Devices and Radiological Health (CDRH)
- Ryan Hohman, JD, MPA Managing Director, Friends of Cancer Research
- Lunch Keynote Speaker Laura R. Broch, PhD, RN, Director, Human Research Protections Office, U.S. Army Medical Research and Materiel Command
- Elizabeth Jungman, JD, MPH, Senior Health Policy Advisory, U.S. Senate HELP Committee
About the Sponsors
The UM Carey School of Law is a national leader in health law, and our conferences are integral tools in expanding practical knowledge on important health law topics and encouraging scholarship on cutting-edge issues. The Law and Health Care Program combines education and research on emerging medical, health policy and legal matters, addressing health law issues from both legal and interdisciplinary perspectives. The Law School’s nationally-recognized Journal of Health Care Law & Policy serves as a forum for interdisciplinary discussion of leading issues in health law, medicine, and health policy. The UM Carey School of Law also boasts strong inteprofessional collaboration with the UM School of Pharmacy and its Center for Drugs and Public Policy.
For decades, Arnold & Porter LLP's FDA and Healthcare practice has been a leader in helping pharmaceutical, biotechnology, medical device, and diagnostic companies, as well as other healthcare entities, respond to complex regulatory and compliance challenges in the US and Europe. The firm assists clients in routine counseling matters, resolving their issues and concerns and supporting key business operations, as well as in the most complex crises-all with an eye on their long-term business and product goals.
Morning refreshments and working lunch will be provided. There is no fee to attend this conference, but registration is required. The event will conclude with a networking reception to be held at Arnold & Porter.