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LIVE WEBCAST

Sponsored by Pharma Compliance Alert

Thursday, June 5, 2008

1:00 p.m. - 2:00 p.m. (Eastern)
12:00 p.m. - 1:00 p.m. (Central)
11:00 a.m. - 12:00 p.m. (Mountain)
10:00 a.m. - 11:00 a.m. (Pacific)

The recently enacted Food and Drug Administration Amendments Act (FDAAA) expands the scope of the current clinical trials registry and increases the requirements for safety assessment, risk evaluation, and risk minimization. Medicare’s decision to no longer pay for preventable medical errors raises questions of who pays when complications occur in the course of a clinical trial. The FDA has also recently come under fire for not adequately ensuring debarred investigators are not involved in clinical trials and Congress has launched inquiries into clinical trials.

Pharmaceutical companies spend large amounts of money on clinical trials for drugs that may never make it to the marketplace. Because of the increased requirements for clinical trials, additional scrutiny of who is conducting the clinical trials, and questions about who pays for a test subject’s complications, you must ensure procedures are in place for your organization to comply with the new rules and prepare for future changes.

Learn to operationalize changes in the law

Discover how to best incorporate nuances of the new laws by attending ePharmaceuticals’ live Webcast: Clinical Trials: Practical Tips to Implement Recent Safety and Reporting Changes on Thursday, June 5, at 1 p.m. (Eastern). During this live 60-minute Webcast, healthcare compliance attorney Amy Dow, J.D. (Epstein Becker & Green, P.C.), and clinical research compliance consultant Lisa Murtha, J.D., CHC (Huron Consulting Group) will discuss practical tips on how to comply with the new FDAAA requirements, as well as strategies to encourage sponsors and investigators to work together to ensure compliance.

At the conclusion of this Webcast, participants will be able to:

• Operationalize the changes in FDAAA to ensure your organization is compliant and able to file accurate certifications of compliance with the FDA.
• Understand the critical changes in clinical trial reporting requirements that will affect the way future research is conducted
• Recognize best clinical practices for conducting compliant, legal trials
• Develop language to be included in contracts outlining the role and financial responsibility of the sponsor for medical complications to subjects

AGENDA

• Food and Drug Administration Amendments Act (FDAAA) changes
• Clinical trials registration requirements
• Results disclosure
• State reporting requirements for clinical trials
• Compliance risk areas
• Tips to improve compliance
• Safety reporting for clinical trials
• Monitoring proper usage of data safety monitoring boards
• OIG, quality of care false claims cases
• Medicare sponsor concerns
• Develop protocols
• Coverage analysis
• Billable vs. non-billable
• Payments for complications to patients enrolled in clinical trials
• Contract negotiations
• Sponsor implications for coverage analysis
• Heightened scrutiny of investigator compliance
• Recent Congressional inquiries and likely increased enforcement activity by the FDA
• Sponsor obligation to ensure investigator compliance
• Common investigator compliance enforcement risks
• Impact of investigator noncompliance on sponsors and their applications
• Tips for sponsors: How to improve investigator compliance and how to ensure your investigators are not on the FDA’s blacklist
• Live Q&A

MEET THE SPEAKERS

Amy K. Dow, J.D., Epstein Becker & Green, P.C. Ms. Dow is an associate in the Health Care and Life Sciences Practice in the firm's Chicago office. She represents and provides regulatory counsel to hospitals and pharmaceutical, medical device and dietary supplemental manufacturers. She is also responsible for negotiating clinical research agreements and related agreements for sponsors, institutions and investigators, as well as developing clinical research policies for Institutional Review Boards and hospital systems.

F. Lisa Murtha, J.D., CHC. Ms. Murtha serves as Managing director of Huron Consulting Group based in New York and Philadelphia.  She focuses her practice in clinical research compliance (human subject protections, effort reporting, scientific misconduct, conflicts of interest, and clinical trial billing and process improvement), revenue cycle work, billing and coding issues, internal investigations, corporate governance/ethics, and HIPAA work. 

WHO SHOULD ATTEND THIS WEBCAST?

Those involved in clinical trials set-up and reporting as well as:

• Compliance
• In-house counsel
• Outside counsel
• Clinical affairs

WEBCAST SYSTEM REQUIREMENTS AND PROGRAM MATERIALS

Please note to fully benefit from the Webcast experience, you will need a computer equipped with sound card, an Internet connection, and speakers. Macromedia Flash player Version 7.0 or higher, a recommended screen resolution of 1024 x 768, and an Internet Browser (e.g. Internet Explorer). The use of AOL is not recommended.

Prior to the Webcast, you will receive an e-mail with detailed system requirements, your log-in information, presentation slides, and other materials that you can print and distribute to all attendees at your location.

CAN’T ATTEND?

No problem. Purchase a CD of the program and listen when you can. It's also a perfect training tool for new staff or as a refresher for veteran staff.

PLEASE NOTE:

• Participation in the Webcast is just $399 per site. All materials must be retrieved from the Internet. Live orders are assessed a $5 processing fee. CD and combo orders are charged $18 for shipping and handling.

• Prior to the Webcast, you will receive an e-mail with detailed system requirements, your log-in information, presentation slides, and other materials that you can print and distribute to all attendees at your location

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