Clinical Trials Disclosure and Reporting Compliance
Navigating Overlapping and Evolving Federal and State Transparency Requirements
Recording of a 90-minute CLE webinar with Q&A
This CLE course will provide guidance to counsel for navigating overlapping and evolving federal and state regulations and existing guidance for clinical trials disclosure and reporting. The panel will offer best practices to ensure transparency during clinical trials and avoid costly mistakes.
Outline
- Clinical trials overview
- Food and Drug Administration amendments Act of 2007 (FDAAA)
- Regulations and guidance related to clinical trial transparency
- State laws on disclosure (trends, key differences among states, key areas of dispute)
- Physician Payment Sunshine Act
- Other transparency legislation
- Conflict of interest legislation
- Corporate Integrity Agreements
- Current trends in foreign clinical trials
Benefits
The panel will review these and other key questions:
- How can counsel reconcile overlapping and sometimes divergent federal and state law requirements regarding clinical trial transparency?
- What compliance best practices should be employed to increase the likelihood of meeting all reporting and disclosure requirements?
- How can counsel help prepare their clients for the Physician Payment Sunshine Act that will soon take effect and other new transparency requirements currently being proposed?
Following the speaker presentations, you'll have an opportunity to get answers to your specific questions during the interactive Q&A.
Faculty
Kristin H. West, J.D.
Associate Vice President & Director
Emory University Office of Research Compliance
Eve M. Brunts
Partner
Ropes & Gray
She regularly advises clients on Medicare and Medicaid coverage, claims and payment requirements for a variety of... | Read More
She regularly advises clients on Medicare and Medicaid coverage, claims and payment requirements for a variety of services; Medicare and Medicaid managed care programs; the Medicaid drug rebate program; Medicaid state plan requirements; reimbursement for health care services in clinical trials; managed care contracting and state managed care laws; and federal and state fraud and abuse laws.
CloseJoseph P. McMenamin
Partner
McGuireWoods
He focuses on health-related litigation, including products liability and toxic torts, risk management and claims... | Read More
He focuses on health-related litigation, including products liability and toxic torts, risk management and claims avoidance, and health law. His practice places particular emphasis on identification and development of the science informing the defense of claims against the manufacturers of medicines, vaccines and medical devices. He holds medical and law degrees from the University of Pennsylvania.
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