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DTSTART:19700308T020000
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UID:2140535:Event:65575
DTSTAMP:20260521T215052Z
SUMMARY:Webinar On Regulatory Issues in Pharmacogenomics
DESCRIPTION:Description :\nThis presentation will begin by giving an o
 verview of Pharmacogenomics and how it is used in drug development. It
  will then identify the agencies that regulate Pharmacogenomics data, 
 and explain what the regulations are. It will then go into detail of t
 he four key challenges for Pharmacogenomics in a regulated industry an
 d offer suggestions for overcoming those challenges to get approval fr
 om the FDA and other regulatory agencies.\n\nAreas Covered in the Sess
 ion :\nWhat is Pharmacogenomics (pgx)\nHow is it used in drug developm
 ent\nWhy talk about regulation\nWho regulates industry activity in thi
 s area\nGuidance Documents\nHow does the FDA harmonize with other agen
 cies that regulate pgx\nKey Challenges for Regulated Industry\nValidat
 ing Biomarkers and submitting genomic data to FDA\nGetting Rx/Dx devel
 opment in synch\nUncertainties about re-imbursement\nEnsuring adequate
  consent for use of samples, including genomic testing\nHow to ensure 
 that your pgx data is accepted by the FDA and other regulatory agencie
 s\nWhat is the outlook for the FDA and pgx\nWho Will Benefit:\nQuality
  Assurance\nRegulatory Affairs\nDocument control managers\nContractors
 \nIT Managers\nQuality Control\nGeneticists\nPharmacokinetic-Drug Meta
 bolism / Pharmacokinetic-Pharmacodynamic Personnel\nVP of PKDM / PKPD\
 nVP of IT\nDoctors\nPrice tags:\nLive\nSingle Live : For One Participa
 nt\n$ 249\nCorporate Live : For Max. 10 Participants\n$ 899\nRecording
 \nSingle REC : For One Participant - Unlimited Access for 6 Months\n$ 
 299\nFor more information and enquiries contact us at\nCompliance Trai
 nings\n5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada\nCustomer 
 Support : #416-915-4458\nEmail : support@compliancetrainings.com\nFor 
 more information about this event please visit\nhttps://compliancetrai
 nings.com/SiteEngine/ProductDetailView.aspx?id=FDB1396\nLike Us On Fac
 ebook:\nhttps://www.facebook.com/events/1545911032360741/?pnref=story\
 n\nFor more information visit https://medtechiq.ning.com/events/webina
 r-on-regulatory-issues-in-pharmacogenomics
DTSTART;TZID=America/New_York:20150403T130000
DTEND;TZID=America/New_York:20150403T143000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:http://bit.ly/1zFP1Am
URL:http://bit.ly/1zFP1Am
CONTACT:4169154458
ORGANIZER;CN=compliancetrainings:https://medtechiq.ning.com/profile/co
 mpliancetrainings
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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