Justine Fassion considers how the various sanctions against Russia are impacting pharmaceutical supply chains, and explains why pharma companies will be affected despite the existence of humanitarian exceptions.
Jay Jariwala in Washington, D.C. and Josefine Sommer in Brussels talk to Raj Pai about how they expect the EU’s new revised Annex 1, EudraLex Volume 4 (GMP), to affect the manufacturing of sterile medicinal products. They discuss how the update reflects changes in the manufacturing environment and how the new Annex 1 is likely to be considered within the U.S. regulatory framework. Prior to joining Sidley, Jay worked for the Office of Compliance at the Center for Drug Evaluation and Research, a branch of the U.S. Food and Drug Administration, and he brings this experience to bear in considering the impact of Annex 1.
Eva von Mühlenen and Alejandro Bes of Novartis consider how the proposed European Health Data Space may speed up research for medicinal products by increasing access to health data, with the help of data scientists within the EU. This development is likely to generate five sticking points that the life sciences industry will need to address, they add.