Compliance Trainings, 5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada
2015-03-04
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
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