Swedish regulator Ulla Wändel Liminga, the incoming chair of the European Medicines Agency’s Pharmacovigilance Committee, will oversee a number of projects including those she was already with such as those related to the safety of medicines during pregnancy and breastfeeding.
Ulla Wändel Liminga, the newly elected chair of the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC), will be overseeing a number of activities in the committee’s 2024 work plan as she assumes her role in September.
There are nearly three dozen activities listed in the PRAC’s 2024 work plan, a number of which are yet...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
