Mind Your P's & Q's and Learn the ABC's of IITs/ISR

Event Details


February 22, 2006

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Topics covered:

Investigator-Sponsored Research:  Procedures, Risks and Real Practice Concerns

Thomas O. Frommel, Ph.D., Manager, External Research, Takeda Pharmaceuticals North America, Inc. – Lincolnshire, Illinois

  • Optimizing organizational structure and procedures in order to maintain compliance with guidelines

  • Minimizing risks relevant to regulatory requirements – Investigational New Drug applications, Institutional Review Board, and Serious Adverse Events

  • Anticipating the unexpected – the real and bizarre situations that can and do occur.  Anecdotes from an IIT/ISR Manager

Investigator-Initiated Trials – What Should Your Contract Address?

Andrew J. Schutt, Esq., Partner, Corporate Practice Group, Arnall Golden Gregory LLP – Atlanta, Georgia

  • How to ensure compliance with investigational new drug/investigational device exemption application ownership requirements

  • How to control publication or dissemination of data from the study

  • Identification of intellectual property rights – who owns what?

  • Indemnification and other risk allocation considerations

  • Confidentiality concerns

(Some) Legal and Regulatory Considerations Relating To Investigator-Initiated Trials

Alan G. Minsk, Esq., Partner, Food & Drug Practice Leader, Arnall Golden Gregory LLP – Atlanta, Georgia

  • Some FDA-Related issues to consider

  • Some fraud and abuse-related issues to consider

  • Use of data from such trials

  • Some questions to ask

  • Recommendations to minimize risk

People who should attend include those in Clinical Affairs, Compliance, Legal, Marketing, Medical Affairs, Medical Communications, Medical Information, Professional Services, and Regulatory Affairs.

Cost is $100 per location. 

Organizer Contact Information:
Kate Frost