Marc Scheineson spoke on the panel "Priorities of a New Administration: Responding to Changes in Scrutiny, Enforcement Budgets and Legislative Initiatives" on Tuesday, February 24, 1:15pm-2:30pm, at this conference hosted by the American Conference Institute (ACI). The panel discussed the following topics...
- Anticipating the priorities of a new FDA Commissioner and NIH
- Predicting the likelihood of passage of budget proposals for increased staff at the FDA
- how potential budget agendas are likely to expedite or delay a clinical trial and steps to best adapt to these changes
- Preparing clinical trial policies for anticipated enforcement actions and agenda items
- Legislative initiatives of the new administration - will clinical trials face even more regulation?
- Pending legislative actions in Congress
- Status updated on legislative and what it could mean for clinical trials
- Senate 3409: Senator Kennedy's bill to create criminal liability for inaccurately certified trial results
- Grassley legislation to incorporate greater transparency
- Congress Dingall's investigations into clinical trials
- Predicting future enforcement interests of Congress and the Administration in clinical trials and other related areas of pharmaceutical and medical device industries
- Existing and growing state interest in regulating clinical trials
American Conference Institute's 11th National Conference on Managing Legal Risks in Structuring and Conducting Clinical Trials was designed to provide an intensive and thorough review of critical issues that arise in ensuring proper management of your protocols, contracts, consents, and other documents. This conference offered attendees experienced in-house speakers, high level industry specialists, and government prosecutors and regulators who presented expert guidance and strategies to minimize the hazards associated with a clinical trial.
February 24-25, 2009
The Affinia Manhattan Hotel / New York, NY