Aligning Clinical Research with Regulatory Processes to Streamline Submissions and Review, Best Practices in Meeting FDA Guidance for PMAs, 510k’s and CLIA Waivers, and In-Depth Analysis of the EU IVDR, with Practical Implementation Steps for Manufacturers
Celebrating 10 years of providing educational support to the diagnostic industry, from the early days of CLIA waivers to the continued debate and evolution of regulatory guidance to support Laboratory Developed Tests, the Q1 Diagnostic Clinical Affairs & Regulatory Approvals conference series has hosted over 800 executives representing cutting-edge tests, ensuring the future growth of the industry through the efficient validation of technology through succinct clinical testing, and increased regulatory certainty leading to commercial success.
In a time of considerable uncertainty at the US FDA, where numerous projects are being delayed or altered, diagnostic companies must continually visit regulatory guidance to ensure current clinical and regulatory activities will support and align with not only future regulatory policy, but also internal commercial goals. Presentations will align not only with current educational deliverables but will also provide a lens focused on case-study application of regulatory guidance and clinical strategies that support and foster the dynamic growth of a wide range of diagnostic technologies.
Eric Jahnke | Sr. Marketing Manager | Q1 Productions
312.955.0424 | email@example.com