Managing Legal Risks in Structuring & Conducting

Clinical Trials

Monday, July 16, 2007

About

The only publication covering the complete clinical trials landscape and which also allows you to navigate clinical trial issues in a global context

Legislation ? Regulation ? Compliance ? Litigation

Clinical trial exposures, liabilities, and risks have never been more daunting - or more real. The clinical trials provisions of recent proposed legislation will have a major impact on FDA authority to require sponsors to conduct Phase IV studies and maintain clinical trial registries. Recent and rampant litigation, including COX-2 trials, have led to increased demand for more transparency in the clinical research process. Questions still remain on the use, ethicality, and accuracy of adaptive trial design, especially after the FDA's announcement that it is taking steps to help facilitate these types of trials. In addition, penalties for noncompliance with proposed drug safety legislation are looming, and damage awards have never been higher. Finally, negative reports continue to flood the media and plague an industry which does not need more bad press.

This publication from American Conference Institute's 7th National Conference on Managing Legal Risks in Structuring & Conducting Clinical Trials was specifically designed to provide you with an intensive and thorough review of the critical issues that arise in ensuring proper management of your protocols, contracts, consents, and other documents.

Contents & Contributors

About

The only publication covering the complete clinical trials landscape and which also allows you to navigate clinical trial issues in a global context

Legislation ? Regulation ? Compliance ? Litigation

Clinical trial exposures, liabilities, and risks have never been more daunting - or more real. The clinical trials provisions of recent proposed legislation will have a major impact on FDA authority to require sponsors to conduct Phase IV studies and maintain clinical trial registries. Recent and rampant litigation, including COX-2 trials, have led to increased demand for more transparency in the clinical research process. Questions still remain on the use, ethicality, and accuracy of adaptive trial design, especially after the FDA's announcement that it is taking steps to help facilitate these types of trials. In addition, penalties for noncompliance with proposed drug safety legislation are looming, and damage awards have never been higher. Finally, negative reports continue to flood the media and plague an industry which does not need more bad press.

This publication from American Conference Institute's 7th National Conference on Managing Legal Risks in Structuring & Conducting Clinical Trials was specifically designed to provide you with an intensive and thorough review of the critical issues that arise in ensuring proper management of your protocols, contracts, consents, and other documents.

Contents & Contributors

Managing Legal Risks in Structuring & Conducting Clinical Trials
Michael A. Swit, The Weinberg Group Inc. (San Diego, CA)
Linda Malek, Moses & Singer LLP (New York, NY)

Identifying and Minimizing Litigation Risks of Clinical Trial Data and Post-Market Adverse Event Reports
Loren H. Brown, DLA Piper (New York, NY)

Clinical Trials: Adverse Events and Liability Concerns
Mary M. Thomson, Gowling Lafleur Henderson LLP (Toronto, Canada)

Adaptive Design for Drug Development
Mark Chang, Ph.D., Millennium Pharmaceuticals, Inc. (Cambridge, MA)

Reacting to Scrutiny of Clinical Trial Disclosures by the SEC
Elizabeth P. Gray, Foley & Lardner LLP (Washington, DC)

Steering Clear of Integrity Problems and Conflicts of Interest in Clinical Trial Research
Priya Mannan, Baxter Healthcare (Deerfield, IL)
Kathleen McDermott, Sonnenschein Nath & Rosenthal LLP (Washington, DC)

Building and Improving Partnerships and Alliances with CRO’S
Alison Macpherson, Bright Pharmaceutical Services (Sherman Oaks, CA)

Managing IP Rights and Patent Infringement Rights in Clinical Trials
James F. Haley, Jr., Ropes & Gray LLP (New York, NY)

Overcoming Legal and Practical Constraints to Clinical Site and Subject Recruitment
Eve M. Brunts, Ropes & Gray LLP (Boston, MA)

Deal Makers and Breakers when Negotiating Clinical Trial Agreements
Stacie Switzer, Takeda Pharmaceuticals North American, Inc. (Deerfield, IL)

Clinical Trial Agreements: Subject Injury
Tamara J. O’Black, St. Paul Heart Clinic (St. Paul, MN)

Implications for Research Negotiation and Contrasting with State Academic Medical Centers
Mariann Shinoskie, CNM, MS, JD, University of Arizona College of Medicine (Tucson, AZ)

Managing and Complying With Clinical Quality Obligations
Bradley Merrill Thompson, Epstein Becker & Green, P.C. (Washington, DC)

An Overview of FDA’s Requirements Relating to Clinical Trials
Alan G. Minsk, Arnall Golden Gregory LLP (Atlanta, GA)

Compliance is the Best Defense: Your Choice – Avoiding or Responding to FDA Clinical Trial Related Enforcement Actions
Robert B. Nicholas, McDermott Will & Emery LLP (Washington, DC)

Conducting Research With Vulnerable Subjects
Cindy Gates, Western Institutional Review Board (Olympia, WA)

Tips, Traps, and Trends in Informed Consent and Secondary Research
Kate Duffy Mazan, Esq., Clinical Technology Transfer Group, PLLC (McLean, VA)

Tackling the Persistent Privacy Problems
Jessica Blazer, Wyeth Pharmaceuticals (Collegeville, PA)
Kristen B. Rosati, Coppersmith Gordon Schermer & Brockelman PLC (Phoenix, AZ)



DOCUMENT TYPES: PRESENTATIONS AVAILABLE: 0