May 21-22, 2012
Co-sponsored with the Food and Drug Law Institute (FDLI)
The legal issues confronting "healthcare lawyers" on the one hand, and "food and drug lawyers" on the other, are no longer separate and discrete. The lines between previously distinct disciplines are blurring, as demonstrated by such developments as rulemaking on possible parallel CMS and FDA reviews of new technology, false claims cases based on FDA "off-label" allegations or violations of cGMP requirements, and coverage and reimbursement disputes involving high tech drugs, devices and biologics. Presented by two of the most respected organizations in their fields, the American Health Lawyers Association and the Food and Drug Law Institute, this joint conference will address three significant areas of intersection: Reimbursement, fraud and abuse, and research/clinical trial issues.
Some of the topics being covered are:
Federal 340B Drug Discount Program
Reimbursement Assistance in a Changing World
Trends in Collaborations: Pharma, Academic Medical Centers and Payors
Coordinating FDA and CMS Strategies in New Product Development
Materials will be available on a website prior to the program. An email will be sent to all the registrants with the weblink.
The Life Sciences Practice Group will hold a luncheon presentation on May 22.
Title: Patient Privacy for the Life Sciences Industry: 2012 Update
Presenter: Andrew Gantt, Partner, Cooley LLP, Washington, DC; Natasha Leskovsek, RN, MBA, JD, Partner, Cooley LLP, Washington, DC
Please note: there is an additional fee, limited attendance and pre-registration required.
This program will be worth approximately 11.75 credits for 60-minute states and approximately 14.1 credits for 50-minute states. Participants will be given CLE Request forms at the program. Forms must be completed and returned to AHLA staff to receive credit. The sessions, unless otherwise designated, are intermediate to advanced in level. There are no prerequisites required to register for this program.
This seminar will be worth approximately 14.0 CPE credits. AHLA is registered with the National Association of State Boards of Accountancy (NASBA) as a sponsor of continuing professional education on the National Registry of CPE Sponsors. State boards of accountancy have final authority on the acceptance of individual courses for CPE credit. Complaints regarding registered sponsors may be addressed to the National Registry of CPE Sponsors, 150 Fourth Avenue North, Suite 700, Nashville, TN 37219-2417. NASBA's web site is located at http://www.nasba.org.
This program is designed to be an update on developments in the area of life sciences. There are no prerequisites or advanced preparations required to register for this group live program. Those seeking accounting credits should be familiar with the basic concepts of law and terminology associated with this area in order to obtain the full educational benefit of this program.
The St. Regis Hotel
923 16th Street, NW
Washington, DC 20006
Room Rates: $345 single or double occupancy
Hotel Cut-Off Date: Monday, April 30, 2012
Hotel accommodations are not included in the registration fee. When making reservations, please indicate that you are with the AHLA/FDLI; the room block may sell out prior to hotel cut-off date.
Cancellations must be received in writing by May 16, 2012. Refunds will not be issued for cancellations received after the cancellation date. Registration fee, minus the $125 administrative fee, will be refunded approximately 3-4 weeks following the program. If you wish to send a substitute, need more information regarding refund, complaint and program cancellation policies please call (202) 833-1100 prompt #5. Note that the registration fee is based on the AHLA/FDLI membership status of the individual who actually attends the program.