Life Sciences Law Institute

The event Life Sciences Law Institute will be held April 25-27, 2007 at the Parc 55 Hotel in San Francisco, CA.  The program is designed to address the unique issues faced by in-house and outside counsel for pharmaceutical companies, biotechnology companies, device manufacturers, academic medical centers, and healthcare providers who have relationships with the life sciences industry. Daniel Meron, General Counsel at the Department of Health and Human Services, will give this year's keynote address. Following the keynote, Linda Freidman from Astellas, and Bruce Garren from Edwards Lifesciences Corporation will discuss The In-Box Issues for Biotech, Drug and Device General Counsels. Breakout sessions will include:

  • Coverage, Reimbursement and Fraud and Abuse Basics for FDA Lawyers;
  • FDA Basics for Healthcare Lawyers;
  • Conducting Effective Internal Investigations and Managing the Whistleblower Threat;
  • Postmarket Safety Issues for Devices;
  • Recent Life Sciences Corporate Integrity Agreements: Consequences for Compliance Auditing and Monitoring;
  • Medicare Part B Coverage, Billing and Payment for Drugs and Biologics Furnished in an Outpatient Setting;
  • Global Compliance Challenges for Life Sciences Companies;
  • Off-Label Promotion: Current Government Theories/Legal and Policy Defenses; and
  • Pharmaceutical Industry Data: What Litigating and Compliance Attorneys Need to Know.

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