The European Medicines Agency will use feedback from two workshops in September to clarify what data protection issues must be addressed to allow for the secondary use of health and medical data when it comes to developing, monitoring and evaluating medicines.
The European Medicines Agency is planning to hold two workshops in September to support ongoing efforts to develop guidance on the impact of the EU General Data Protection Regulation (GDPR) on the secondary use of health data to support the development, evaluation and supervision of medicines.
The first workshop, to be held on 23 September, will be a virtual event where patients and consumers as...
<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>
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
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.
