EU IVDR - Process, Data, Reporting & Planning March 30 - April 27, 2021 | 5 Episode Webinar Series
Complimentary Registration Sponsored by:
The European In Vitro Diagnostic Regulation (EU IVDR) will profoundly affect the global diagnostics market, requiring new procedures, evidence development, documentation, organizational structures, reporting, data management, and a reassessment of legacy portfolios. Even the largest and best-prepared companies struggle with implementation, which involves strategic thinking and buy-in at the highest levels. Anyone can read the regulation: the challenge is in how to apply it to a company’s particular structure and product line. Implementation of IVDR is scheduled for May 2022, with no indication that it will be deferred. For those who have not already begun planning for the change, it is urgent to begin now or face exclusion from the European market. 5 Weekly Episodes
- March 30 - EU IVDR: The European CE IVD Approval Process Explained
- April 6 - Quality Processes and Documentation
- April 13 - Clinical Evidence & Surveillance: Clinical and Postmarket Requirements
- April 20 - Supply Chain Management: Economic Operators, UDI, and Labeling
- April 27 - Strategy and Planning
Confirmed Speakers:
- Bassil Akra, CEO & Founder, Qunique GmbH
- Carolyn Bird, VP of Regulatory, Quality & Clinical, Nextern
- Peter O'Blenis, CEO, Evidence Partners
- Richard Vincins, VP Global Regulatory Affairs, Oriel STAT A MATRIX
- Julien Senac, Ph.D., Director, IVD Global Focus Team, TUV SUD
- Seth Goldenberg, VP, Vault Medical Device & Diagnostics, Veeva Medtech
- Jon Marion, Associate Director, Clinical Quality, Abbott
- Alex Charitou, Associate Partner, EY / International MedTech Leader
- Cindy Ballas, IVDR Project Lead, Ortho Clinical Diagnostics
- Geoffray Colson, Head, RAQA EMEAC-LATAM, Hologic
- Nikki Willett, Chief Strategy Officer, ComplianceQuest
- Jay Crowley, VP of Medical Device Solutions & Services, USDM Life Sciences
- Ravi Nabar, Head - Global QMS & Compliance, Illumina
- Cindy Ballas, IVDR Project Lead, Ortho Clinical Diagnostics
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