Webinar 1: Analytical Validation and Performance Verification—Key Components for IVDR Compliance

In this recorded webinar, we share experiences and insight into the analytical validation (AV) journey. We also explore ISO 15189 and other relevant validation guidelines, as well as examine the need for an analytical validation from a regulatory perspective. This webinar will:

• Identify reasons and requirements to complete an analytical validation
• Describe Thermo Fisher Scientific’s approach to consulting on an AV project
• Outline the assay performance verification and analytical validation as tools to help ensure your workflow is optimized under the appropriate validation guidelines

Webinar 2: IVDR Transition—Impact and Opportunities for a Molecular Pathology Laboratory

In this recorded webinar, we discuss the value of the new In Vitro Diagnostic Regulation (IVDR) legislation and the impact for molecular pathology laboratories and biotechnology and pharma industries, and the benefit for the future of precision medicine. This webinar will:

• Explain the differences between the In Vitro Diagnostic Medical Devices Directive (IVDD) and IVDR and the benefits of the new legislation
• Identify the IVDR challenges and bottlenecks that industries are facing and key actions to be prepared
• Discuss IVDR impact on laboratory-developed tests and implications for a molecular pathology laboratory and patients