October 14-16, 2009
Renaissance Washington DC Hotel
Washington, DC
In cooperation with AdvaMed, BIO and PhRMA
Navigant Consulting, Inc. has provided sponsorship in support of this program.
Program Description
The Life Sciences program is the most effective educational conference on issues where health law and life sciences overlap. These two areas of law are being seen more frequently as extensions of one another. As with all AHLA programs, the Life Sciences program will be a very practical, high quality program for life sciences or health lawyers. Dr. Sharfstein, the Principal Deputy Commissioner of the FDA, will give the keynote address on October 15, followed with a panel discussion on Healthcare Reform with representatives from AdvaMed, PhRMA and BIO. Other plenary session speakers include Rich Feinstein, Director, Bureau of Competition at the FTC; Billy Tauzin, President of PhRMA, and Mike Loucks, U.S. Attorney in Boston and heavily involved in enforcement actions related to the Life Sciences industry.
Breakout sessions will cover significant legal issues inlcuding:
- Conducting Clinical Trials in the US and Abroad: Navigating the Rising Tide of Regulation and Risk
- Pharma and Device Company Relationships with Physicians under Fire
- Structuring Outsourcing Transactions for Success—A Problem-Solving Workshop
- HIPAA, HITECH, GINA and FDA Privacy Rules: How the Alphabet Soup of Privacy and Security Laws Apply to Life science Companies
- Biosimilars: Issues, Controversies and Challenges
- FDA Regulatory Requirements: Updates from the FDA's Office of Combination Products
- Anatomy of a Government Investigation
The program begins in the late afternoon on October 14 at approximately 4:00 pm with the AdvaMed, AHLA and Washington Legal Foundation co-sponsored panel discussion on "How to Protect Consumers while Encouraging Innovation:The Federal Preemption Debate," followed by a reception. The program ends mid-day on October 16.
Practice Group Luncheon
The Life Sciences Practice Group will hold a luncheon and presentation on Thursday, October 15. Please note, there is an additional fee; pre-registration is required; space is limited.
Title: Human Gene Patents
Presenters: Jon F. Merz, MBA, JD, PhD, Associate Professor, Center for Bioethics, University of Pennsylvania, Philadelphia, PA, and Hans Sauer, PhD, JD, Associate General Counsel for Intellectual Property
Biotechnology Industry Organization, Washington, DC
In response to many requests from our members, AHLA is going green for in-person program. We are trying to reduce the amount of paper we use at our programs. This is both an effort at responsible environmental conservation, and an effort to increase the timeliness of the materials provided to our attendees. We will not automatically be printing binders for everyone. 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 the binder they will be available for an additional fee; please order on the registration form.
CLE Information
This program will be worth approximately 12.25 credits (including 1.0 ethics credit) for 60-minute states and approximately 14.7 credits (including 1.2 ethics credit) 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 www.nasba.org.
This program is designed to be an update on developments in the area of managed care. 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 the area of managed care in order to obtain the full educational benefit of this program and are required to sign in and out of every session during the program.
Hotel Information
Renaissance Washington DC Hotel
999 9th Street NW
Washington, DC
Phone: (202) 898-9000