Meeting Highlights from CHMP Changed to Web Page
Taking advantage of technology, highlights from the Committee for Medicinal Products for Human Use (CHMP) meetings can now be viewed online through the European Medicines Agency (EMA) website. The first meeting to have highlights available online can be seen here, from the September 19-22 assembly.
In a press release, the EMA indicated the new format would let users view, ”the main opinions adopted at the meeting, along with information on safety reviews, in a clear tabular format.” Individual press releases and other documents will also be available via links through the online meeting summary.
A new web page will be submitted after each month’s CHMP meeting.
Users can voice their opinion about the new format here. Any changes to the new design will be made in early 2012.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
FDA Grants Priority Review to Merck’s sBLA for Winrevair After Early Success in ZENITH PAH Trial
July 2nd 2025Merck’s bid to update Winrevair’s label advances with FDA priority review, backed by Phase III ZENITH data showing a 76% reduction in major morbidity and mortality events in patients with pulmonary arterial hypertension.
