The artificial intelligence revolution has arrived, but are pharmaceutical companies ready to meet the expectations of regulators? Lawyer Vincenzo Salvatore outlines the EU regulatory and policy developments that are relevant to the use of AI in the medicinal product lifecycle.
Artificial intelligence (AI) has the potential to streamline pharmaceutical R&D processes in a multitude of ways, from generating novel vaccine antibody designs to rapidly analyzing large swathes of clinical trial data.
However, with great potential comes great risk, at least in the eyes of the European Commission, which in April 2021...
<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>
As the reform of the EU pharmaceutical legislation progresses through the legislative process, the Pinks Sheet offers an infographic highlighting some of the key changes being proposed that will reshape the way drug companies run their business.
<p>Executive Summary<p> <p>The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, incl/ding Ixchiq, Valneva's chikungunya virus vaccine</p>
A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
