Potential impact of IVDR on diagnostic testing in Europe – What are the implications for the pharmaceutical industry?
Read our latest blog on “Potential impact of IVDR on diagnostic testing in Europe – What are the implications for the pharmaceutical industry?”
Written by Joe Clune, CDx commercialisation consultant and Stewart McWilliams, VP of Quality and Regulatory Affairs at Almac Diagnostic Services, the blog covers the following key topics:
- Introduction to IVDR
- IVDR – What’s New?
- Challenges in the implementation of IVDR
- Background – Companion Diagnostics
- The evolving landscape of approved tests vs LDTs
- Will Europe still have LDTs with IVDR?
- What does Pharma need to do?
Diagnostic Services
Your global partner for biomarker discovery, development & commercialisation.
Genomic Services
We offer a range of genomics platform and chemistry options, alongside expert data sciences support and a full sample management service.
Clinical Trial Assays
Comprehensive development, validation & delivery service for research and clinical use assays from our global clinical laboratories in USA, Europe and APAC.
Companion Diagnostics
A collaborative Companion Diagnostic partnership approach with a deep understanding of client needs. We offer CDx development, manufacture & commercialisation services.
