Dezember 12, 2019 - Dezember 13, 2019
/ USA - San Diego, United States
Event: IVD Clinical & Regulatory Affairs Conference
Date: 12th of December - 13th of December 2019
Location: Andaz San Diego Hotel, United States
Qserve's panel member: Lorry Weaver Huffman, US Regulatory Affairs Expert
About the Conference:
Diagnostic test sophistication, including the rapid integration of Next Generation Sequencing and machine learning into diagnostic testing are changing the way that healthcare professionals approach diagnosis, as well as the regulations surrounding such advanced methods. From the US FDA’s stance surrounding regulation of Laboratory Developed Tests (LDTs) as well as Next Generation Sequencing, to considerations of the EU IVDR, regulatory affairs executives face a wide range of challenges in ensuring tests meet evidence and regulatory dossier requirements.
Core Topics to be Addressed:
- Strategic Alignment for Companion Diagnostics
- Post-Market Surveillance & Quality Concerns
- Implementation of European IVDR
- Regulatory Changes for Varied Test Categories
For more information or registrations, please click here.