BEGIN:VCALENDAR X-WR-TIMEZONE:America/Chicago PRODID:-//University of Iowa//Events 1.0//EN VERSION:2.0 CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240329T144347Z DTSTART:20181108T140000 DTEND:20181108T150000 SUMMARY:IND Holder Responsibilities: The Role of the Sponsor-Investigator DESCRIPTION:The Principal Investigator becomes the sponsor-investigator of a project when they hold an Investigational New Drug (IND) application to the FDA. This includes added responsibilities for record keeping and reporting\, both to the FDA and to the IRB\, beyond what a PI would normally do for research where the sponsor holds the IND. This session will focus on sponsor-investigator responsibilities AFTEr the IND is received:\n\n\n An overview of the roles of the sponsor and the investigator as IND holder\n A review of FDA regulations and UI IRB policies and procedures about PI oversight responsibilities. \n FDA warning letters (and how to avoid receiving one)\n\n\nResearchers who may apply for a future IND and current sponsor-investigators are encouraged to attend this presentation for an orientation or a review of the roles and responsibilities of an IND-holder.\n\nPlease register at https://uiowa.qualtrics.com/jfe/form/SV_9SGBJdh2c4g1kjP. \n\n\nhttps://events.uiowa.edu/15162 LOCATION:Pomerantz Family Pavilion\, Braley Auditorium (01136 PFP)\, 720 Melrose Avenue\, Iowa City\, IA 52242 UID:edu.uiowa.events-prod-15162 X-ALT-DESC;FMTTYPE=text/html:
The Principal Investigator becomes the sponsor-investigator of a project when they hold an Investigational New Drug (IND) application to the FDA. \; This includes added responsibilities for record keeping and reporting\, both to the FDA and to the IRB\, beyond what a PI would \;normally do for research where the sponsor holds the IND. This session will focus on sponsor-investigator responsibilities AFTEr the IND is received:
\n\nResearchers who may apply for a future \;IND and current sponsor-investigators are encouraged to attend this presentation for an orientation or a review of the roles and responsibilities \;of an IND-holder.
\n\nPlease register at \;https://uiowa.qualtrics.com/jfe/form/SV_9SGBJdh2c4g1kjP. \;
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