Clarification of Regulatory Requirements for Companion Diagnostics & NGS, Insight into the Status of Laboratory Developed Test Specific Policies, all while Strategizing to Ensure Compliance with New European & Asian Market Rules
Considering the increasing number of IVD test categories and the ongoing rise of companion diagnostics as well as next generation sequencing products, regulatory teams are in need for a clarification of the FDA’s intent to further regulate tests based on specific analyses methods and therapeutic applications, as well as an accrued understanding of the influence of new test types on policy development. In addition, the inconsistency in the FDA’s oversight of laboratory developed tests continues to raise challenges and questions from the industry. In order to meet evolving and uncertain demands, keeping abreast of regulatory changes and new opportunities for expedited product submission and approval remains a priority for regulatory teams.
The Q1 Productions IVD Regulatory Affairs Conference will bring together industry leaders, as well as health authority representatives from the USA and beyond to discuss recent and impending guidance of the highest importance. With a focus on the US market in addition to an outlook on international requirements such as the impact of the IVDR in Europe, and evolving submission and clinical requirements in Asian markets, the conference ensures a holistic approach to pressing regulatory matters. Via a mix of formats including panel discussions, exchange groups, and traditional presentations, attendees have the opportunity to take away actionable content through engaging sessions and the sharing of best practices. The event will also offer a unique networking platform for delegates to connect with a multitude of key experts in the field.
This program is eligible for up to 12.0 RAC credits. A certificate of attendance and final digital copy of the agenda will be provided to all attendees upon request. For further details regarding the submission process for RAC credits, please visit: https://www.q1productions.com/raps-credit/
Eric Jahnke | Sr. Marketing Manager | Q1 Productions
312.955.0424 | firstname.lastname@example.org