Addressing Industry Concerns Regarding FDA Regulation and Compliance While Improving Utilization of Clinical Outcome Assessments through Increased Instrument Efficiency and the Utilization of Innovative Technologies to Ensure FDA Label Inclusion
Clinical Outcome Assessments within the pharmaceutical industry provide critical data to researchers to support a variety of claims, from safety to cost-effectiveness, to regulatory bodies as well as healthcare providers and third-party payers. While outcomes information has been collected for some time, and both from a wide variety of sources and in varied formats, there has been little harmonization in the ultimate reporting and utilization of this critical information. The Q1 Maximizing Clinical Outcome Assessments Conference will provide an opportunity for executives throughout the industry for high-level education and networking, blending perspectives from academia, industry-veterans, and regulatory authorities.
This conference will take place in Alexandria, Virginia on January 13-14, 2014. For organizations addressing challenges in maximizing clinical outcome assessments, the first step is to understand regulatory hurdles faced by the industry, and the evolving expectations from FDA for reporting and communicating research findings. Additional sessions will cover a range of topics, including presentations highlighting various instruments that can be utilized to collect reported outcomes, as well as new applications and mobile technologies, modernizing the methods through which this information is gathered. Insightful commentary will also provide detail on validation methods, as well as methods for working with the range of observers and with the most appropriate tools for those populations.
KEY CONFERENCE TAKEAWAYS
- Addressing FDAs Perspective On Utilizing Clinical Outcome Assessment
- Focusing On Implementation Strategies That Will Affect Label Claim Submissions
- Review Costly Compliance Concerns That Effect The Pharmaceutical Industry
- Sharpening Techniques And Methodologies To Maximize COA Utilization
- Validating COAs Through The Power Of Social Media
- Optimizing The Use Of Critical COA Evidence Beyond The Label
- Evaluating The Considerations For COAs In Children And Adolescents