Regulatory Issues in Pharmacogenomics

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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.

Submission of Pharmacogenomics data as part of a drug or biologic submission, impacts the approval of the submitted product. Complying with FDA requirements on the subject will help with approval of the submitted product. In addition, regulations are coming into place, for the re-imbursement of the genomic tests.

This presentation will describe the agency expectations, describe how to correctly submit Pharmacogenomics data for faster approval by the agency, and what to expect from the regulatory agencies in the near future.

Areas to be Covered:

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

Angela Bazigos

Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services.

Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Past employers / clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers & Stanford Hospital. Positions include Chief Compliance Officer,Director of QA and MIS Director. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA & DIA Patent on speeding up software compliance.

Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom includes training for Society of Quality Assurance.

Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for LifeSciences.

This product is currently out of stock and unavailable.

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  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance