Foreign Clinical Trials not conducted under an IND (21 CFR 312.120)

This webinar will discuss requirements for acceptance of foreign clinical studies, the guidance for foreign investigator qualification, foreign research facility requirements and study monitoring documentation.

Learning objectives:

• Participants will achieve a higher level of confidence for conducting non-IND foreign clinical trials that will be used to support marketing applications in the US
• Participants will have references and resources to guide them when including foreign clinical study results in marketing applications.

Who will benefit:

• Clinical Research Professionals
• Clinical Protocol Developers
• Clinical Study Managers
• Regulatory Managers
• Clinical Study Directors
• CROs
• Sponsors

Instructor Profile:

Dr. Hanover, has worked in clinical research for over 30 years, as a Principal Investigator for studies funded by national agencies such as NIMH, Veteran’s Affairs, and DOD as well as various private pharmaceutical and medical device companies, as a Professor teaching research methods, biostatistics, and evidence-based medicine at the University of Utah School of Medicine, a Consultant to the Utah State Department of Health, and Director of Clinical Research for Techniscan Medical Systems. She has concurrently held consulting positions for such companies as Pherin Pharmaceuticals, Utah Cancer Specialists, Montgomery-Watson Environmental Engineering, and Planned Parenthood Federation of America. She earned a Regulatory Affairs Certification (RAC) in 2006 through RAPS, and is also a member of the Society of Clinical Research Associates (SOCRA), and the American Statistical Association (AMSTAT).