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    Webinar On Regulatory Issues in Pharmacogenomics

    View: 323

    Website http://bit.ly/1zFP1Am | Want to Edit it Edit Freely

    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 development

    Why talk about regulation

    Who regulates industry activity in this area

    Guidance Documents

    How does the FDA harmonize with other agencies that regulate pgx

    Key Challenges for Regulated Industry

    Validating Biomarkers and submitting genomic data to FDA

    Getting Rx/Dx development in synch

    Uncertainties about re-imbursement

    Ensuring adequate consent for use of samples, including genomic testing

    How to ensure that your pgx data is accepted by the FDA and other regulatory agencies

    What is the outlook for the FDA and pgx

    Who Will Benefit:

    Quality Assurance

    Regulatory Affairs

    Document control managers

    Contractors

    IT Managers

    Quality Control

    Geneticists

    Pharmacokinetic-Drug Metabolism / Pharmacokinetic-Pharmacodynamic Personnel

    VP of PKDM / PKPD

    VP of IT

    Doctors

    Price tags:

    Live

    Single Live : For One Participant

    $ 249

    Corporate Live : For Max. 10 Participants

    $ 899

    Recording

    Single REC : For One Participant - Unlimited Access for 6 Months

    $ 299

    For more information and enquiries contact us at

    Compliance Trainings

    5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada

    Customer Support : #416-915-4458

    Email : supportatcompliancetrainings.com

    For more information about this event please visit

    https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1396

    Like 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.
    Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.