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.
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