Manager of Regulatory Affairs, EMEA, Thermo Fisher Scientific
BIOGRAPHY
JAN 25, 2022 10:00 AM CET
IVDR transition -- impact and opportunities for a molecular pathology laboratory
Presented at:
Lab Compliance Connect
Speakers
-
Johanna Koolen
Senior Regulatory Analyst, Thermo Fisher ScientificBIOGRAPHY
Abstract
In this webinar, you’ll learn about the value of the new in vitro diagnostic regulation (IVDR) and its impact on molecular pathology laboratories, biotechnology and pharma industries, as well as its benefit to the future of precision medicine.
Learning objectives:
• Explain the differences between in vitro diagnostic directive (IVDD) and IVDR, and the benefits of the new regulation
• Identify the IVDR challenges and bottlenecks that industries are facing and ways to mitigate them
• Discuss the IVDR impact on laboratory-developed tests (LDTs) and implications for molecular pathology laboratories and patients
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