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Legal and Compliance Issues in Biomedical Innovation 

(Formerly the Life Sciences Law Institute)
January 26, 2011
Ritz-Carlton Hotel
Washington, DC

Program Description

This one-day program on biomedical innovations is strategically placed the day before the Legal Issues for Academic Medical Centers and Other Teaching Institutions. This combination will bring together the brightest legal minds representing pharmaceutical, biotech, and medical device companies with their academic medical center counterparts, all focused on the issues that define their interaction.  The content, exchange, and networking will be unique and beneficial to counsel and compliance officers for all of these institutions.

The program will feature sessions ranging from significant public policy issues to hard core legal issues that emerge in the relationships between life sciences companies and teaching hospitals. The program will kick-off with a Margaret Anderson of FasterCures discussing Disruptive Innovation: Medical Trends to Watch in 2011. The plenary session will also include a discussion on compliance and enforcement issues with AUSA from the Eastern District of New York, Paul Kaufman, formerly with the US Attorney's Office in Boston, now with Skadden Arps law firm, Michael Loucks, and Director of the FDA Office of Enforcement, Howard Sklamberg. Following the panel will be a discussion on Conflicts of Interest and the industry-academic relationship with Dr. Guy Chisolm, Tanaz Dutia, Dr. Tom Stossel, and Dr. Sally Rockey.

In-depth breakout sessions include:

  • Comparative Effectiveness: What It Is and Whay It Matters to You
  • Global Health - International Clinical Trials Agreements
  • Wrestling Over Human Tissue: Yours, Mine or Ours?
  • MSP Mandatory Reporting - Implications in the Clinical Trial Context
  • Stem Cell Research

Practice Group Luncheon
The Life Sciences Practice Group will hold a luncheon and presentation. 

Title: The New Approval Pathway for Biosimilars: Next Steps, Open Issues, and Implications for the Biotech and Generic Drug Industries
Presenter: Madison C. Jellins, Life Sciences Intellectual Property Practice, Alston & Bird LLP, Menlo Park, CA

Please note: There is an additional fee, pre-registration is required, and space is limited.

Program Materials
All materials will be available on a website prior to the program and handed out on CD at the program. For those who still do want printed version of the materials, they will be available for an additional fee; please order on the registration form.

CLE Information

CLE/MCLE: This program will be worth approximately 7.25 credits for 60-minute states and approximately 8.7 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.

CPE: This seminar will be worth approximately 8.0 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.

Download Continuing Legal Education Request

Hotel Information
Ritz-Carlton Hotel
1150 22nd Street, NW
Washington, DC 20037
Reservations: (202) 835-0500

Room Rates: $255 single or double occupancy
Hotel Cut-off Date: Wednesday, January 5, 2011
Hotel accommodations are not included in the registration fee. When making reservations, please indicate that you are with the American Health Lawyers Association; the room block may sell out prior to hotel cut-off date.

Travel Information

Official Travel Provider – ATC (Association Travel Concepts) 

Discounts and Services:

  • 5% off applicable classes of service for tickets purchased more than 30 days prior to the meeting. Restrictions apply and not all classes of service apply for the 5% discount. (United Airlines).
  • Personalized services.
  • Low fare options.
  • Discounted meeting rates (Enterprise, Hertz)
  • Advanced seat assignment and special meal requests. Frequent flier program updates

Some restrictions may apply. *Service fees apply to ticketed reservations. You may also call your own agency or the vendors directly and refer to the ID numbers.

Cancellation/Substitutions
Cancellations must be received in writing by January 20, 2011. Refunds will not be issued for cancellations received after the cutoff date. Registration fee, minus the $50 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 membership status of the individual who actually attends the program.

 


 
Related Resources

 Program Brochure

 Registration Information

Biomedical Innovation Program Only
AHLA Member: $345
Non-Member: $570
Printed Course Material: $35

Registering for BOTH Biomedical Innonvation and Academic Medical Centers programs:
AHLA Member: $990
Group Rate: $915
Government/Academic Member: $590
Non-Member: $1215
Government/Academic Non-Member: $665

For those, paying by check or registering at the group rate discount, please use the Printable Registration Form

 Exhibitors

The following companies will be exhibiting at the program:

  • HORNE LLP
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