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Session 4: Global Perspective: EU, Consultant, Japan, RoW
Session Chair(s)
Miu Chau, PhD
Senior Regulatory Program Director
Genentech, A Member of the Roche Group, United States
Currently companion diagnostics do not require pre-marker authorization by a regulatory authority in the EU. The manufacturers only need to perform conformity assessment on the in vitro diagnostics (IVDs), i.e., self-certification, for CE marking. In other countries, such as China and Japan, companion diagnostics registrations are independent of drug approval. However, with the increasing number of drugs requiring companion diagnostics to identify patients for treatment the global regulatory framework is gradually changing to keep up with the innovations. For example, the European Commission put forward a proposal for a regulation on in vitro diagnostic medical devices in 2012. This session will explore the potential impact of the changing global regulatory framework on different aspects of companion diagnostic development, e.g., analytical and clinical performance requirements, risk-based classification, regulatory approval/certification process, etc.
• How the CPDx will be reviewed
• Revised IVD directive
• Chinese perspective
Speaker(s)
Global Regulation of Companion Diagnostics: Current Status and Future Trends
Julie S. Engel, PhD, RAC
Ventana Medical Systems, United States
Director, Companion Diagnostics Regulatory Affairs
Regulatory Considerations for Companion Diagnostics in Asia
Rosanne Welcher, PhD, MBA, RAC
Dako North America, an Agilent Technologies Company, United States
Senior Director, Quality Assurance, Regulatory and Clinical Affairs
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