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Biomarkers for Drug Development: The Emerging Regulatory Landscape
Tuesday, August 14, 2012 from 10:00 AM to 11:00 AM (PDT)
Palo Alto, CA
This training provides an up-to-date understanding of regulatory requirements for the development and implementation of biomarkers in drug development programs, as well as highlights of the most recent FDA sources on general, imaging (Including PET) and pharmacogenomic biomarkers.
Why Should You Attend:
This session will cover the emerging regulatory aspects for all classes of biomarkers: biomarkers of (1) efficacy, (2) toxicity, (3) dose-selection, & (4) patient-selection. The utility of each of these four classes of biomarkers varies according to the degree of validation, the business model of the company using them, and the terms under which regulatory approval is sought.
This training will enable industrial scientists and clinicians to understand the recent guidances on biomarkers and companion diagnostics and allow them to prepare detailed roadmaps ensuring proper qualification and implementation of biomarkers to a standard that will be accepted by the FDA in registration packages for either small molecule drugs or biologicals.
An up-to-date understanding of regulatory requirements for the development and implementation of biomarkers in drug development programs, as well as highlights of the most recent FDA sources on general, imaging (Including PET) and pharmacogenomic biomarkers.
Areas Covered in the Seminar:
- Types of biomarkers and their regulatory implications.
- Overviews of emerging regulatory aspects for all classes of biomarkers.
- Specific guidances for biochemical, genomic and imaging biomarkers.
- Elements constituting context of use for a biomarker.
- The qualification process for biomarkers.
- Context, structure and format of regulatory submissions for qualification of biomarkers.
- Definition and use of a Companion Diagnostic Device.
- Applicable standards when imaging is used to assess a primary endpoint.
- Definition of clinical, investigative and research use in the context of PET drugs.
- Clinical evaluation of pharmacogenomics.
Date: August 14, 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.
When & Where
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
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- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.