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Session 5: Global Regulatory Perspective
Session Chair(s)
Miu Chau, PhD
Senior Regulatory Program Director
Genentech, A Member of the Roche Group, United States
Companion diagnostics development needs to take into consideration the global regulatory requirements for worldwide registrations. 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, in the European Commission’s proposed new framework, companion diagnostics will be classified as high individual risk or moderate public health risk (Category C) and require conformity assessment by a notified body instead of by self-certification. In Japan, the PMDA published a ‘Technical Guidance on Development of In-Vitro Companion Diagnostics and Corresponding Therapeutic Products in 2013’. This session will explore the potential impact of the changing global regulatory framework on the different aspects of companion diagnostic development.
Speaker(s)
Regulatory Perspective and Challenges Regarding Companion Diagnostics in Japan
Sumimasa Nagai, MD, PhD
Kyoto University Hospital, Japan
Institute for Advancement of Clinical and Translational Science(iACT)
Overview of Current and Future European Regulatory Requirements for Companion Diagnostics
Shayesteh Fürst-Ladani, MBA, MS
SFL Regulatory Affairs & Scientific Communication, Switzerland
CEO
China CFDA Enters Into the Era of Co-Review/Co-Approval of Companion Diagnostics
Rosanne Welcher, PhD, MBA, RAC
Dako North America, an Agilent Technologies Company, United States
Senior Director, Quality Assurance, Regulatory and Clinical Affairs
Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product
Pamela Bradley
FDA, United States
Staff Fellow, Office of In Vitro Diagnostics & Radiological Health, CDRH
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