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The regulatory interplay between medical devices and medicines in clinical trials - EU and U.S. focus (Part 1)
The regulatory frameworks for medicines and medical devices have historically grown up on separate tracks, but increasingly, medicines and medical devices are being used together in patients as drug device combinations, companion diagnostics and medical devices used in clinical trials.
Join Sapna Palla, Eda Zhuleku and Rafi Allos in part one of this podcast series to discuss the use of medical devices in clinical trials and the different perspectives between the EU and U.S., as well as the regulatory requirements that may apply.
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By Ginting & Reksodiputro in association with A&O ShearmanThe regulatory frameworks for medicines and medical devices have historically grown up on separate tracks, but increasingly, medicines and medical devices are being used together in patients as drug device combinations, companion diagnostics and medical devices used in clinical trials.
Join Sapna Palla, Eda Zhuleku and Rafi Allos in part one of this podcast series to discuss the use of medical devices in clinical trials and the different perspectives between the EU and U.S., as well as the regulatory requirements that may apply.