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UID:2140535:Event:61996
DTSTAMP:20260523T153836Z
SUMMARY:Regulatory Differences Between Biopharmaceutics and Medical De
 vices
DESCRIPTION:This webinar will review the similarities and differences 
 in the regulatory paths and requirements for drugs, biologics and medi
 cal devices. It will discuss the applicable FDA “Centers,” the IDE
  and IND process, as well as 510k, PMA, NDA and BLA submission process
 es.\nWhy Should You Attend:\nDo you currently have responsibility in t
 he regulatory group for drugs but want to learn more about devices or 
 vice versa?\nAre you confused by all the FDA Centers and want to know 
 the applicable FDA division for your technology?\nAre you launching a 
 drug-device combination product and need to map out a parallel regulat
 ory path?\nWould you like to do a clinical research study utilizing a 
 non-approved drug or biologic?\nDo you want to know if a device meets 
 the category for IDE exemption?\nThis webinar will review FDA regulato
 ry requirements for approval of drugs and biologics and the clearance 
 of medical devices. You will gain an understanding of the Centers for 
 Drugs (CDER), Devices (CDRH), and Biologics (CBER), their requirements
  for clinical research (IND vs. IDE), as well as the path for approval
  or clearance to sell product in the US. You will learn about the path
  for 510k clearance or PMA (pre market approval) for devices, and NDA 
 (new drug applications) and BLA (biologics license applications) for b
 iopharma products. Combination product regulations will also be review
 ed.\nLearning Objective:\nAt the end of this webinar, participants wil
 l understand regulatory similarities and differences between drugs, bi
 ologics, and devices.\nAreas Covered in the Webinar:\n\nReview of FDA 
 regulations for biopharma vs. devices\nFDA Centers: CDER, CBER, CDRH\n
 What if the product is a combination product…which do I lead with?\n
 What is the difference between the requirements for an IND vs. IDE?\nW
 hat are the requirements for a 510k (class I and II) and PMA submissio
 ns?\nWhat is needed for NDA and BLA submissions?\n\n\nFor more informa
 tion visit https://medtechiq.ning.com/events/regulatory-differences-be
 tween-biopharmaceutics-and-medical
DTSTART;TZID=America/New_York:20130808T100000
DTEND;TZID=America/New_York:20130808T110000
CATEGORIES:fda, compliance
LOCATION:Online Event
WEBSITE:http://www.complianceonline.com/ecommerce/control/trainingFocu
 s/~product_id=703020?channel=medtechiq
URL:http://www.complianceonline.com/ecommerce/control/trainingFocus/~p
 roduct_id=703020?channel=medtechiq
CONTACT:+1-650-620-3915
ORGANIZER;CN=Referral:https://medtechiq.ning.com/profile/Referral
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562006570?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Referral:
 https://medtechiq.ning.com/profile/Referral
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