Why Companies Globally Should Start Preparing Now for the European Health Data Space

Zina Chatzidimitriadou and Francesca Blythe explain how a revolutionary EU regulation, expected to come into force in 2025, will allow life sciences companies to request health data for secondary re-use, but will also expose them to more data requests.

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How to Create a More Enabling Environment for Digital Health in Europe

At our recent Digital Health App’ero, Zina Chatzidimitriadou led a discussion with key industry players Aleksandra Appelfeld of Philips and Megan Coder of the Digital Therapeutics Alliance on what changes the industry would like to see in order to make Europe more hospitable to digital health products. We set out the top five themes that emerged, and a space to watch for the next decade.

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Five Global Bellwether Trends for Clinical Trials

Scott Bass explains why taking a multi-disciplinary, multi-continent approach to the planning of clinical trials will help you anticipate regulatory changes and ward off investigations.

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Scott Bass

New York, Washington, D.C.

sbass@sidley.com

Are China-only Clinical Trials Enough for U.S. Approvals?

Torrey Cope looks at the recent FDA emphasis on the challenges of a China-only trial strategy. He explores the FDA concern that a China-only clinical trial will be unable to prove that a drug is suitable for the U.S. population, and considers the regulatory requirements for U.S. approvals based on ex-U.S. trial data.

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New European Focus on Medicine Supply Chains Means More Disclosure

Maurits Lugard and Anna-Shari Melin examine the new era of supply chain scrutiny and explain how the EMA’s new critical medicines lists will work.

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