Investigator Initiated Trials: Compliance Challenges and Best Practices

WEBCAST ON CD

Sponsored by Pharma Compliance Alert

presented on June 13, 2007

From the False Claims Act and the anti-kickback statute to adverse event collecting and reporting, when initiating an investigator-initiated trial (IIT) you face a magnitude of compliance RULES, REGULATION, and RISK.

Navigate the maze of compliance rules and regulations related to IIT

In an age of increasing prosecutorial interest in research grant awarding activities, establishing a compliant and productive IIT has never been more important. During this program, our speakers detail the key regulatory risks associated with IITs and present two “Inside a Company” case studies that provide practical solutions on how to ensure compliance.

Offering expert tips and best practices, this program will help you:

• Identify the potential regulatory/legal benefits and risks associated with IIT programs
• State key metrics used to measure IIT program productivity and value
• Describe several approaches other companies have taken to accomplish compliant and effective IIT programs
• Understand departmental roles in facilitation of IITs
• Maintain independent monitoring activities
• Avoid bias in company support
• Structure agreements with investigators

At the end of the program, you’ll walk away with the information and real-world advice you need to evaluate and implement IITs.

PROGRAM AGENDA

1. Evaluating and implementing investigator-initiated trials (IIT)
1.  Top compliance issues regarding investigator-initiated trials
2.  Issues to consider when deciding whether IIT are right for the organization
3.  Different approaches to managing IITs

• Hands-on vs. hands-off approaches
• Expectations

2. Inside a company: Takeda
1. Takeda’s approach to grant requests/ managing IITs
2. Compliance issues related to grant submission and review the role of:

• Medical & Scientific Affairs
• Sales and Marketing
• Regulatory and Legal
• Intellectual Property

3. Real-world issues/practical solutions

3. Inside a company: NitroMed
1. NitroMed’s approach to grant requests/managing IITs
2. Staying compliant during the study
3. Real-world issues/practical solutions

4. Question and answer session

FEATURED SPEAKERS

David L. Hoffman, J.D, is an associate in Arnall Golden Gregory, LLP Litigation Practice Group, in Atlanta, GA. His practice focuses on the areas of environmental law, food and drug law, and the drafting and negotiating of construction/architectural contracts.

Stephen M. Shinall, PhD, is manager of external research grants for Takeda Pharmaceuticals North America, Inc., in Deerfield, IL.  Shinall oversees the administration of research grant application submission, review, and support in three therapeutic areas served by TPNA (Diabetes & Metabolism, Neuroscience, and GI).

Welton O'Neal, Jr., Pharm.D., is vice president of medical affairs at NitroMed in Lexington, MA, where he manages BiDil-related medical affairs, including professional services, medical education, medical compliance and awareness efforts., and the field based medical liaisons. Dr. O'Neal has extensive medical affairs experience, including in medical services, science and advocacy, cardiovascular, oncology and internal medicine as well as managed care.

WHO SHOULD LISTEN?

• Compliance
• Regulatory
• Legal
• Clinical
• Medical and scientific affairs professionals as well as those involved in research and development

WEBCAST SYSTEM REQUIREMENTS

Please note that to fully benefit from the Webcast experience, you will need a computer equipped with an Internet connection, sound card, and the following browsers: Netscape Navigator 4.7 or Internet Explorer version 5 or higher.

YOUR MATERIAL PACKET

In addition to the expertise and advice presented during this Webcast, you'll also receive a slide presentation of the program materials. These materials are provided with PDF links. 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.

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