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Changing Global Regulatory Climates: Effects on Companion Diagnostics and Combination Products

Track:
Medical Devices, In Vitro Diagnostics, and Combination Products

Day & Time:
June 18, 8:00AM - 9:30AM (Pacific Standard Time)

Session Number:
313

Room Number:
11A

Level:
Intermediate

Type:
Session

Title:
Changing Global Regulatory Climates: Effects on Companion Diagnostics and Combination Products

Chair(s):
Shayesteh Fuerst-Ladani, MBA, MS
Director
SFL Regulatory Affairs & Scientific Communication, Switzerland

Description:
This session will focus on EU and US FDA developments in the regulation of drug/device combination products and companion diagnostics with an emphasis on clinical considerations. The session will provide an overview of the revision of the EU medtech legislation and summarize the main changes of the latest development of the proposed medical devices and in vitro diagnostic regulations. This will include an assessment on the impact of these changes on the regulatory framework for combination products and companion diagnostics. How these amendments will affect clinical study design of drugs and companion diagnostics will be highlighted. The session will also include discussion of FDA current and future guidance, including human factor considerations in developing combination products.

Learning Objective(s):
Describe the latest update on the revision of EU medtech law and impact on regulatory processes for companion diagnostics and combination products; Discuss considerations for clinical studies for companion diagnostics and drugs; Provide an overview of current FDA technical guidance on specific product areas and guidance in development.

Presentation(s) & Speaker(s):
Revision of EU Medtech Law: Impact on Regulatory Framework of Companion Diagnostics and Combination Products
Shayesteh Fuerst-Ladani, MBA, MS
Director
SFL Regulatory Affairs & Scientific Communication, Switzerland

Global Clinical Trial Design Considerations When Incorporating a Companion Diagnostic
Sabah Malek
Associate Director, Global Regulatory Affairs
Eisai Inc., United States

US FDA Regulation of Combination Products: Clinical and Technical Considerations
Patricia Y. Love, MD, MBA
Deputy Director, Office of Combination Products, OC
FDA, United States