BEGIN:VCALENDAR
VERSION:2.0
PRODID:-//Penn IRB - ECPv6.15.20//NONSGML v1.0//EN
CALSCALE:GREGORIAN
METHOD:PUBLISH
X-ORIGINAL-URL:https://irb.upenn.edu
X-WR-CALDESC:Events for Penn IRB
REFRESH-INTERVAL;VALUE=DURATION:PT1H
X-Robots-Tag:noindex
X-PUBLISHED-TTL:PT1H
BEGIN:VTIMEZONE
TZID:America/New_York
BEGIN:DAYLIGHT
TZOFFSETFROM:-0500
TZOFFSETTO:-0400
TZNAME:EDT
DTSTART:20240310T070000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0400
TZOFFSETTO:-0500
TZNAME:EST
DTSTART:20241103T060000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:-0500
TZOFFSETTO:-0400
TZNAME:EDT
DTSTART:20250309T070000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0400
TZOFFSETTO:-0500
TZNAME:EST
DTSTART:20251102T060000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:-0500
TZOFFSETTO:-0400
TZNAME:EDT
DTSTART:20260308T070000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0400
TZOFFSETTO:-0500
TZNAME:EST
DTSTART:20261101T060000
END:STANDARD
END:VTIMEZONE
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20251030T140000
DTEND;TZID=America/New_York:20251030T153000
DTSTAMP:20260426T093206
CREATED:20250902T161029Z
LAST-MODIFIED:20250902T161029Z
UID:4754-1761832800-1761838200@irb.upenn.edu
SUMMARY:IRB 101: Regulatory Requirements for Investigator Initiated Studies Involving Drugs and Devices
DESCRIPTION:If you’re designing a study with a drug or a device – 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 will explain what IND and IDE exemptions are\, criteria that must be met\, and the review process at Penn. \n  \nTarget Audience: Penn Medicine and Penn Dental faculty\, research staff\, post docs\, and students. \n  \nSign up for the sessions here. \n  \nAny questions can be directed to Diana Floegel\, Senior Regulatory Analyst and IRB 8 Chair\, at floegeld@upenn.edu.
URL:https://irb.upenn.edu/event/irb-101-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
END:VEVENT
END:VCALENDAR