Webinar On Regulatory Issues in Pharmacogenomics
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Category Food, Drugs & Biologics
Deadline: March 04, 2015 | Date: March 04, 2015
Venue/Country: Mississauga, Canada
Updated: 2015-02-25 21:30:57 (GMT+9)
Call For Papers - CFP
Description : This presentation will begin by giving an overview 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 the four key challenges for Pharmacogenomics in a regulated industry and offer suggestions for overcoming those challenges to get approval from the FDA and other regulatory agencies.Areas Covered in the Session :What is Pharmacogenomics (pgx)How is it used in drug developmentWhy talk about regulationWho regulates industry activity in this areaGuidance DocumentsHow does the FDA harmonize with other agencies that regulate pgxKey Challenges for Regulated IndustryValidating Biomarkers and submitting genomic data to FDAGetting Rx/Dx development in synchUncertainties about re-imbursementEnsuring adequate consent for use of samples, including genomic testingHow to ensure that your pgx data is accepted by the FDA and other regulatory agenciesWhat is the outlook for the FDA and pgxWho Will Benefit:Quality AssuranceRegulatory AffairsDocument control managersContractorsIT ManagersQuality ControlGeneticistsPharmacokinetic-Drug Metabolism / Pharmacokinetic-Pharmacodynamic PersonnelVP of PKDM / PKPDVP of ITDoctorsPrice tags:LiveSingle Live : For One Participant$ 249Corporate Live : For Max. 10 Participants$ 899RecordingSingle REC : For One Participant - Unlimited Access for 6 Months$ 299For more information and enquiries contact us atCompliance Trainings5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada Customer Support : #416-915-4458 Email : supportcompliancetrainings.comFor more information about this event please visithttps://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1396Like Us On Facebook:https://www.facebook.com/events/1545911032360741/?pnref=story
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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