Jul 212022

Five Global Bellwether Trends for Clinical Trials

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Scott Bass

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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Jul 122022

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

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Eva von Mühlenen and Josefine Sommer

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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Jul 72022

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

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Torrey Cope

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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Jul 12022

New European Focus on Medicine Supply Chains Means More Disclosure

Maurits J.F. Lugard and Anna-Shari Melin

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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Jul 12022

Making Manufacturing Sites Inspection-ready After the Pandemic Gap

Raj D. Pai

Due to COVID-19, many pharmaceutical manufacturing sites have not experienced a regulatory inspection in several years. Raj Pai discusses how to ensure that Good Manufacturing Practices are in place.

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