DUBLIN--(BUSINESS WIRE)--Research and Markets (http://www.researchandmarkets.com/research/8z7wnj/how_to_get_a_clia) has announced the addition of the "How to get a CLIA Waiver for your Medical Device: One and a Half Day In-person Seminar 2015" conference to their offering.
Location : San Diego, CA. Thursday, February 26, 2015 - Friday, February 27, 2015.
FDA has granted precious few applications for waiver since their CLIA Waiver guidance was published on January 30, 2008. Between 2008 and 2012, FDA reviewed 34 applications for CLIA Waiver and approved 14, sometimes taking years to issue a denial. The cost of performing CLIA Waiver studies, combined with the lengthy review times and likelihood of failure, has discouraged companies from bringing new innovations to this critical public health sector.
With the CLIA Waiver guidance appearing to be so prescriptive, why has denial dominated the review outcome?
By attending this two-day workshop conference on Clinical Laboratory Improvement Amendments (CLIA) attendees will:
- Know how to submit a CLIA Waiver application that conforms to FDA's CLIA Waiver guidance.
- Understand how the FDA determines performance requirements for CLIA Waiver and what to expect during their review.
- Learn how to design risk-based flex studies and develop cost-saving product development and clinical study strategies.
- Be able to review FDA's CLIA categorization criteria and examine ways to incorporate simple and negligible chance of erroneous results into product design.
- Understand how CLIA Waiver requirements have evolved, FDA's point of view and how to maximize your chances for a successful CLIA Waiver application.
Upon completing this course participants will know how to:
- Use FDA's CLIA categorization scoring criteria.
- Understand FDA's 2008 CLIA Waiver Guidance and cope with its shortfalls.
- Integrate human factors and usability engineering into CLIA Waived products.
- Design and execute Flex studies based on risk analysis.
- Design and execute CLIA Waiver clinical studies for qualitative and quantitative devices.
- Design and execute studies and sample panels to evaluate performance near the cutoff.
- Develop compliant labeling for CLIA Waived products.
- Prepare a CLIA Waiver application.
- Perform and present statistical analysis of data.
- Avoid costly mistakes.
- Apply money- and time-saving strategies for development of CLIA-Waived products.
- Maximize the chances for a successful CLIA Waiver application.
Who Will Benefit:
- Executives and Senior Managers
- R&D Personnel
- Design Engineers
- Regulatory Professionals
- Project Managers
- Risk Management Professionals
- Clinical Research Professionals
For more information visit http://www.researchandmarkets.com/research/8z7wnj/how_to_get_a_clia