BEGIN:VCALENDAR
VERSION:2.0
PRODID:-//OTRADI - ECPv6.18.2//NONSGML v1.0//EN
CALSCALE:GREGORIAN
METHOD:PUBLISH
X-ORIGINAL-URL:https://www.otradi.org
X-WR-CALDESC:Events for OTRADI
REFRESH-INTERVAL;VALUE=DURATION:PT1H
X-Robots-Tag:noindex
X-PUBLISHED-TTL:PT1H
BEGIN:VTIMEZONE
TZID:America/Los_Angeles
BEGIN:DAYLIGHT
TZOFFSETFROM:-0800
TZOFFSETTO:-0700
TZNAME:PDT
DTSTART:20240310T100000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0700
TZOFFSETTO:-0800
TZNAME:PST
DTSTART:20241103T090000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:-0800
TZOFFSETTO:-0700
TZNAME:PDT
DTSTART:20250309T100000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0700
TZOFFSETTO:-0800
TZNAME:PST
DTSTART:20251102T090000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:-0800
TZOFFSETTO:-0700
TZNAME:PDT
DTSTART:20260308T100000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0700
TZOFFSETTO:-0800
TZNAME:PST
DTSTART:20261101T090000
END:STANDARD
END:VTIMEZONE
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20250430T120000
DTEND;TZID=America/Los_Angeles:20250430T130000
DTSTAMP:20250401T205819Z
CREATED:20250317T163833Z
LAST-MODIFIED:20250401T205819Z
UID:10002319-1746014400-1746018000@www.otradi.org
SUMMARY:Virtual Lunch & Learn: FDA Meetings-Strategies for Success
DESCRIPTION:As part two of our three-part Virtual Lunch & Learn series on U.S. drug development\, this session will focus on the critical role of FDA interactions in a successful pharmaceutical development strategy. \nPart 2 will provide a more in-depth understanding of communications with the FDA to facilitate successful product development. We will discuss the different types of interactions and meetings available to sponsors during critical points in the regulatory and strategic product development process. Positive and productive interactions are important to the program; these interactions and associated timelines need to be considered in the overall development program. Interactions help the sponsor to understand the role of the FDA and product-specific offices and\, more importantly\, provide feedback and guidance on the development program. \nJoin us for this essential session to learn how to optimize FDA interactions\, navigate regulatory touchpoints\, and integrate agency feedback into a streamlined development strategy. \nRegister HERE
URL:https://www.otradi.org/event/virtual-lunch-learn-2/
CATEGORIES:Lunch & Learn,OBI Programs/Events
END:VEVENT
END:VCALENDAR