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DTSTART:19700308T020000
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UID:2140535:Event:55950
DTSTAMP:20260520T122744Z
SUMMARY:3-hr Virtual Seminar: IND Applications for Phase I Studies
DESCRIPTION:This 3-hr virtual seminar will review FDA’s IND requirem
 ents for Phase I and First-in-Man (FIM) clinical trials. It will cover
  the structure of an IND document and discuss granular and sectional I
 ND creation strategies and practical approaches for an IND submission.
 \nWhy Should You Attend:\nAll sponsors of clinical trials in the US fo
 r drug and biologics have to first file an Investigational New Drug (I
 ND) application with the FDA containing extensive information in suppo
 rt of the proposed clinical trial. The IND application contains all av
 ailable preclinical and clinical testing information, and all manufact
 uring information for the investigational product, along with clinical
  protocol, informed consent template, investigator’s brochure and ot
 her relevant information. These requirements are particularly tough fo
 r sponsors of Phase I and First-in-Man (FIM) clinical trials since the
 se trials are usually planned early on in the development phase with l
 imited preclinical information and may use a preliminary formulation o
 f the investigational product.This 3-hr virtual seminar would discuss 
 general and specific issues to be considered for IND containing Phase 
 I and FIM trials. This seminar is a must for those writing their first
  IND application, particularly those moving a new product from R&D pha
 se into clinical phase of development. Attending this workshop is a go
 od step toward making sure that your next IND meets FDA requirements a
 nd gets a “Safe to Proceed” letter from the FDA within 30 days fro
 m submission. This workshop contains a collection of practical tips fr
 om the trainer’s extensive IND submission experience.\n \n\nFor mor
 e information visit https://medtechiq.ning.com/events/3-hr-virtual-sem
 inar-ind-applications-for-phase-i-studies
DTSTART;TZID=America/New_York:20120629T100000
DTEND;TZID=America/New_York:20120629T130000
CATEGORIES:pharmaceutical, training
LOCATION:Online Event
WEBSITE:http://www.complianceonline.com/ecommerce/control/trainingFocu
 s/~product_id=702353?channel=medtechiq
URL:http://www.complianceonline.com/ecommerce/control/trainingFocus/~p
 roduct_id=702353?channel=medtechiq
CONTACT:16506203915
ORGANIZER;CN=Referral:https://medtechiq.ning.com/profile/Referral
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562006613?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Referral:
 https://medtechiq.ning.com/profile/Referral
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