Webinar Duration: 90 minutes
RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)
SPEAKER: Angela Bazigos
OVERVIEW:
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.
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
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:
– Doctors
– Geneticists
– VP of PKDM/ PKPD
– PKDM / PKPD Personnel
– VP of IT
– IT Managers
– Quality Control
– Quality Assurance
– Regulatory Affairs
– Document Control Managers
– Contractors
SPEAKER PROFILE:
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, http://morflearning.com/angelabazigos/, 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 http://www1.diahome.org/~/media/4FA562336EBD46C58CDC43A8B7773095.ashxPatent on speeding up software compliancehttps://www.google.com/patents/US8266578 . Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroomhttp://blogs.wsj.com/riskandcompliance/2015/07/24/using-training-to-bring-compliance-to-boardrooms/ 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: http://www.stanfordwhoswho.com/Angela.Bazigos.7144112.html#overview.
