BEGIN:VCALENDAR
VERSION:2.0
METHOD:PUBLISH
PRODID:-//Telerik Inc.//Sitefinity CMS 14.4//EN
BEGIN:VTIMEZONE
TZID:Mountain Standard Time
BEGIN:STANDARD
DTSTART:20251102T020000
RRULE:FREQ=YEARLY;BYDAY=1SU;BYHOUR=2;BYMINUTE=0;BYMONTH=11
TZNAME:Mountain Standard Time
TZOFFSETFROM:-0600
TZOFFSETTO:-0700
END:STANDARD
BEGIN:DAYLIGHT
DTSTART:20250301T020000
RRULE:FREQ=YEARLY;BYDAY=2SU;BYHOUR=2;BYMINUTE=0;BYMONTH=3
TZNAME:Mountain Daylight Time
TZOFFSETFROM:-0700
TZOFFSETTO:-0600
END:DAYLIGHT
END:VTIMEZONE
BEGIN:VEVENT
DESCRIPTION:This talk will describe the types of early communications with 
 the FDA and the high level requirements for nonclinical programs supportin
 g clinical development of 4 product types: small molecules\, protein thera
 peutics\, prophylactic vaccines and cell and gene therapies. Case studies 
 will be provided.\n\nSpeaker: Melanie Hartsough\, Independent Consultant a
 t Hartsough Nonclinical Consulting\, LLC
DTEND:20220428T000000Z
DTSTAMP:20260508T150454Z
DTSTART:20220427T220000Z
LOCATION:
SEQUENCE:0
SUMMARY:Shining a Light on the FDA Black Box: A Nonclinical Perspective
UID:RFCALITEM639138494940392674
X-ALT-DESC;FMTTYPE=text/html:This talk will describe the types of early com
 munications with the FDA and the high level requirements for nonclinical p
 rograms supporting clinical development of 4 product types: small molecule
 s\, protein therapeutics\, prophylactic vaccines and cell and gene therapi
 es. Case studies will be provided.<br />\n<em></em>\n<p><em>Speaker: Melan
 ie Hartsough\, Independent Consultant at Hartsough Nonclinical Consulting\
 , LLC</em></p>
END:VEVENT
END:VCALENDAR