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DTSTART:19700308T020000
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UID:2140535:Event:63654
DTSTAMP:20260522T133118Z
SUMMARY:Webinar On FDA’s Biosimilar (Generic Biologics) Process
DESCRIPTION:This web presentation presents an overview of FDA’s requ
 irements for approval/marketing of a Generic Biologic (Biosimilar) in 
 the USA. This webinar covers the Biosimilar product testing requiremen
 ts (clinical and nonclinical) and the Biosimilar approval pathway. The
  webinar also reviews the Regulatory/Scientific/Quality principles inv
 olved along with the 3 FDA Biosimilar guideline documents. The FDA Ste
 p-wise Approach and the FDA Totality of Evidence concepts will also be
  discuss.\nAreas Covered in the Session :\nBPCI Act\nDefine the terms 
 Biosimilar and Interchangeability\nFDA's Stepwise Approach\nFDA's Tota
 lity-of-the - Evidence Approach\nThe Biosimilar Approval pathway\n \n
 Who Will Benefit:\nRegulatory Affairs Personnel\nQuality Personnel\nCl
 inical Personnel\nResearch Personnel\nManufacturing Personnel\nLegal P
 ersonnel\nAuditors\nClinical Research Associates\nPersonnel who requir
 e an understanding of the FDA Biosimilar process\nPrice Tags:\nLive\nS
 ingle Live : For One Participant\n$ 249\nCorporate Live : For Max. 10 
 Participants\n$ 899\nRecording\nSingle REC : For One Participant - Unl
 imited Access for 6 Months\n$ 299 \n\nFor more information visit http
 s://medtechiq.ning.com/events/webinar-on-fda-s-biosimilar-generic-biol
 ogics-process
DTSTART;TZID=America/New_York:20140508T130000
DTEND;TZID=America/New_York:20140508T150000
CATEGORIES:webinar
LOCATION:5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada
WEBSITE:https://compliancetrainings.com/SiteEngine/ProductDetailView.a
 spx?id=FDB1223
URL:https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?
 id=FDB1223
CONTACT:4169154458
ORGANIZER:Compliance Trainings
ATTACH;FMTTYPE="image/jpeg":
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=complianc
 etrainings:https://medtechiq.ning.com/profile/compliancetrainings
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