Roche CDx News & Brews Virtual
Understanding the Impact of IVDR on Your Diagnostic Strategy & Overcoming Its Complex Challenges
David Roberts, PhD
Tuesday, September 14
8am PDT | 11am EDT
With the European Union’s In Vitro Diagnostics Regulation (IVDR) set to go into full effect in May 2022, Roche Diagnostics has led the industry in its proactive approach to understanding the requirements involved in certification and deep investment in transitioning its portfolio of CE-marked IVD products. In the process, it has gained critical expertise in the unique and complex challenges presented in ensuring compliance for companion diagnostics (CDx) assays. This Roche CDx News & Brews will shed light on fundamental considerations for biopharma companies and how key lessons learned from Roche’s journey can be applied to navigate CDx development and registration in the IVDR era.
It Will Cover:
- What is IVDR and what does it mean for biopharma companies?
- How does IVDR impact companion diagnostic assays?
- How is an intended purpose for a product defined, and what data and documentation are required to support this for a CDx?
- The importance of pharmaceutical and diagnostic collaboration in companion diagnostic development, including the initiation process for clinical trials and regulatory approval process to bridge access for patients
WHO SHOULD ATTEND
Roche CDx News & Brews is an exclusive event series, adapted to a virtual format, providing leaders in pharma and biotech the opportunity to connect with industry thought leaders and explore the latest innovations in technologies that facilitate the advancement of precision medicine.
YOUR EXPERT SPEAKERS
ABOUT THE SPEAKER
David Roberts, PhD is a seasoned Project Leader with the Roche CDx organization who has led several key CDx biomarker programs to successful global IVD launches. He holds a doctorate in Bioanalytical Chemistry from the University of Arizona and brings 10 years of diagnostic industry experience. In his current role, he is part of a core team of 30+ individuals supporting the IVDR transition and is responsible for leading the implementation of IVDR for the Roche CDx product portfolio.