Regulatory Perspectives on Pharmacogenomics: A Review of Key Issues Faced by FDA

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Webinar Includes : All the training handouts , Certificate by the Speaker ,Q/A and 90 Min Live Webinar

"Hear By Angela Bazigos who recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom"

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

Description

Pharmacogenomics (a portmanteau of pharmacology and genomics) is the study of the role of genetics in drug response. It deals with the influence of genetic variation on drug response in patients by correlating gene expression or single-nucleotide polymorphisms with drug absorption, distribution, metabolism and elimination, as well as drug receptor target effects. Pharmacogenomics may be used interchangeably with the term pharmacogenetics, which focuses on the effects of candidate genes in drug response. Pharmacogenomics aims to develop rational means to optimize drug therapy, with respect to the patients' genotype, to ensure maximum efficacy with minimal adverse effects. Such approaches promise the advent of "personalized medicine"; in which drugs and drug combinations are optimized for each individual's unique genetic makeup.

Why should you attend

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 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

  •     Doctors
  •     Geneticists
  •     VP of PKDM/ PKPD
  •     PKDM / PKPD Personnel
  •     VP of IT
  •     IT Managers
  •     Quality Control
  •     Quality Assurance
  •     Regulatory Affairs
  •     Document control managers
  •     Contractors

Industries who can attend

This 90-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Speaker Profile

Angela Bazigos

Angela Bazigos.CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers. Positions include Chief Compliance Officer at Morf Media. Co-authored & prototyped 21 CFR 11 guidance with FDA.  Co-authored Computerized Systems in Clinical Research w/ FDA. Patent on speeding up software compliance. Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom. National Trainer 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 Life Sciences.

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