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

Event Details

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
kate.frost@agg.com
404.873.8521