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SUMMARY:IRB 8
DESCRIPTION:Video Conferencing/Human Research Protections Program Office of the Institutional Review Board 3600 Civic Center Blvd\, 9th Floor
URL:https://irb.upenn.edu/event/irb-8-28/
CATEGORIES:IRB Meetings
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SUMMARY:Regulatory Requirements for Investigator Initiated Studies Involving Drugs and Devices
DESCRIPTION:If you’re designing a study with a drug or device (e.g.\, lab test\, software application\, or other device product) – do you know if you need an Investigational New Drug (IND) or an Investigational Device Exemption (IDE) Application? Can your study be exempt from the IND or IDE regulations? Attend our Regulatory Requirements for Investigator Initiated Studies Involving Drugs and Devices training! This session is a collaboration with Penn Medicine’s Office of Clinical Research and will explain what IND and IDE exemptions are\, criteria that must be met\, and the review process at Penn. This session may be of interest to those in Penn Medicine\, Penn Dental\, and Penn Engineering. \nAll sessions will last 60-90 minutes to allow time for Q&A. Sessions will be held via Zoom. Zoom links will be distributed to attendees via email about 24 hours before each session begins. \nAny questions can be directed to Diana Floegel\, Senior Regulatory Analyst and IRB 8 Chair\, at floegeld@upenn.edu. \nSign up for the sessions HERE.
URL:https://irb.upenn.edu/event/regulatory-requirements-for-investigator-initiated-studies-involving-drugs-and-devices/
LOCATION:Zoom
CATEGORIES:Educational Series
ORGANIZER;CN="Diana Floegel%2C PhD":MAILTO:floegeld@upenn.edu
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