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.
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…)
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.
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.
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.