The Top Three Pandemic Manufacturing Inspection Techniques That Are Here to Stay

With many pharmaceutical manufacturing facilities unaccustomed to in-person GMP inspections since the pandemic, Arif Noorani, Josefine Sommer, and Daniel Roberts examine how inspection techniques have evolved.

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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‘Ring-fencing’ Biological Targets in Collaboration Agreements

Stephen Abreu explains how licensors can make sure they do not give a licensee unintended rights to biological targets arising out of their own internal research, or from separate collaborations with third parties.

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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

The Challenges Facing Artificial Intelligence and Machine Learning Solutions in the FemTech Space

Sidley’s Eva von Mühlenen in Geneva and Josefine Sommer in Brussels talk to oncologist Wolfgang Hackl — the founder of a FemTech startup that guides doctors in the treatment of breast cancer — about regulation, research and development (R&D), and the vast potential of artificial intelligence in the field of health technology for women. (more…)

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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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