A two-day workshop saw EU policymakers and regulators meet with dozens of representatives from the pharmaceutical, health and medtech industries to discuss the future of regulating AI in medicine and its uses in the medicinal product lifecycle.
The EU Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) brought together a wide range of stakeholders spanning the health and medical industries on 20-21 November as part of a push to develop regulatory guidance on the use of artificial intelligence (AI).
One purpose of the joint HMA/EMA workshop, which was hosted by the agencies’ big data steering group, was to offer...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
