2015 - Webinar On Regulatory Issues in Pharmacogenomics

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 : support-AT-compliancetrainings.com
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