ComplianceOnline, United States
2012-10-03
Why Should You Attend: The implementation and validation of pharmacokinetic and immunogenicity methods have rigid and clear regulatory expectations. However, a priori specifications for biomarker methods cannot be generalized because enough fluidity is required for suitable trust in the method for the intended purpose without obstructing progress.
In this webinar, participants will first learn how to understand the various types of assay read-outs and their implications on biomarker validation. The next session will showcase how biomarkers have been used successfully to predict the utility of certain drugs on key diseases at various phases of development. The final session will provide guidance in selecting key reagents and controls followed by logical expectations for accuracy, precision and specificity based on the ultimate purpose of the biomarker assay. Learning Objectives: Learn how to select and validate a fit for purpose biomarker method that will provide suitable guidance during a particular development phase. Areas Covered in the Seminar: - Biomarker definition and nomenclature.
- Hierarchy of biomarkers.
- Verification of disease relevant biomarkers.
- Review of technologies used for biomarker studies.
- Selection of appropriate controls and reagents.
- Industry expectations of biomarker method validations.
- Situations when CLIA validations are required.
Event Details: Date: October 03, 2012 Time: 10:00 AM-11:00 AM PDT Cost: $249 per attendee per computer terminal Registration: SIgn-Up on-line now. Add to your shopping cart.
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Invited Speakers:
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Dr. Menendez, is currently an international instructor, author and consultant on GMP/GLP Bioassay and Bioanalytical Method Development and Validation. In her previous position as Senior Director of Biotechnology at Catalent Pharma Solutions she implemented various laboratories to verify the functionality and safety of biotechnology products using cellular, molecular and immunological technologies. Her expertise covers potency bioassays, PK, PD and immunogenicity testing. Her latest industry papers provide recommendations for cell banks used in GMP/GLP analysis and multiple factor at a time development for ligand binding methods.
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