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Managing Legal Risks in Structuring & Conducting Clinical Trials
from Miscellaneous Group
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Tuesday, September 23, 2008 7:30am - Wednesday, September 24, 2008 2:45pm
American Conference Institute’s 10th National Conference on Managing Legal Risks in Structuring & Conducting Clinical Trials is the one place that industry professionals can come to resolve these and other pressing concerns. At a time when the pressure on and outcry against the industry have never been greater and negative reports continue to flood the media, this is the only event that will allow you to respond to the increased demand for more transparency in the clinical research process from every angle: legislation, regulation, compliance, and litigation. Its front-line faculty includes experts from sponsors, CROs, hospitals and academic research institutions, as well as expert attorneys and current and former government enforcers.
The risk of penalties and fines for noncompliance have never been more more real:
* The new FDAAA clinical trial certification requirement has caused considerable uncertainty in the applicability of PHS Act § 402(j) to submissions
* Manufacturers are subject to differing state clinical trial registration and results disclosure requirements and the variations are complicating compliance
* The FDA has new enforcement authority over post-marketing trials, including the ability to require sponsors to conduct Phase IV studies
In addition, critical issues arise in ensuring proper management of protocols, contracts, consents, and other documents, including negotiation of the applicable agreement documents in light of the different perspectives and priorities of the parties involved. Plus, the daily management of clinical trials, from the challenges of ensuring properly structured recruiting incentives and overcoming key Medicare issues to the tight rope that is avoiding data privacy and security pitfalls, is a potential minefield of exposure.
And new frontiers, including legal risks involved in tailored therapies, are just over the horizon.
American Conference Institute’s 10th National Conference on Managing Legal Risks in Structuring & Conducting Clinical Trials is the one place that industry professionals can come to resolve these and other pressing concerns. At a time when the pressure on and outcry against the industry have never been greater and negative reports continue to flood the media, this is the only event that will allow you to respond to the increased demand for more transparency in the clinical research process from every angle: legislation, regulation, compliance, and litigation. Its front-line faculty includes experts from sponsors, CROs, hospitals and academic research institutions, as well as expert attorneys and current and former government enforcers.
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