Includes 1 Hour Windows Media Video File and PowerPoint presentations for immediate download.
About the Product
Includes 1 hour Windows Media Video File and PowerPoint presentations for immediate download.
Clinical professionals within the diagnostic industry are given the difficult task of not only proving a test’s safety and effectiveness, but also demonstrating how the product is preferred over those already on the market. In 2013, the FDA published draft guidance on Design Considerations for Pivotal Clinical Investigations for Medical Devices to be used in parallel with the 2007 Guidance on Reporting Results for Diagnostics Test Evaluations. These guidance documents provide a solid framework for the design and analysis of diagnostic clinical studies, a critical aspect to the overall success of a diagnostic product. In order to run a successful study, diagnostic clinicians must take a proactive approach to study design and understand the key requirements for compliance.
- FDA diagnostic regulatory guidance and updates
- Methods for framing study goals, recruitment and site selection
- Comparison of clinical outcome studies and clinical performance studies
- Best practices for collecting clinical evidence
Senior Vice President of Regulatory Services
Participants that will find this webinar most beneficial will be those involved in diagnostics companies. Job titles of attendees that will be most applicable for this session will be:
- Regulatory Affairs
- Regulatory Operations
- Clinical Trials
- Clinical Operations
- Companion Diagnostics
- Quality Affairs