Life science companies are at the center of the debate on health reform, whether it is the level of reimbursement for their products, enforcement actions to regulate their corporate conduct, or the debate over the level of protection for their intellectual property. The Life Sciences Law Institute 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 Law Institute will be a very practical, high quality program for life sciences or health lawyers.
Epstein Becker Green attorney Lynn Shapiro Snyder will speak at the session entitled "Inspector General Panel: Keeping a Close Eye on the Integrity of Federal Health Programs."
Epstein Becker Green attorney Bradley M. Thompson will speak at the session entitled "FDA Regulatory Requirements: Updates from the FDA's Office of Combination Products."
Topics to be covered include:
- Combination products and how they are regulated by FDA
- Combination product market size and trends
- Combination product regulation and enforcement, including:
o GMPs for combination products
o Adverse event reporting
o Injector guidance
o Likely future direction and developments
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Challenges and opportunities
For more information and to register, click here.