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
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 Should Attend
- Doctors
- Geneticists
- VP of PKDM/ PKPD
- PKDM / PKPD Personnel
- VP of IT
- IT Managers
- Quality Control
- Quality Assurance
- Regulatory Affairs
- Document Control Managers
- Contractors
