EMA considerations on the use of AI in the medicinal product lifecycle.
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COVID-19: European Medicines Agency Updates
Latest updates from EMA in response to the COVID-19 pandemic.
Simultaneous National Scientific Advice (SNSA)
The EU Pilot for 2 Member States to gain simultaneous national scientific advice is launched on 1st February. Find out more here.
Nitrosamine MAH Risk Assessment – Two Months to Go
Two Months to Go – Human medicinal product licences to be reviewed for the presence of Nitrosamine Impurities
Nitrosamines, TOPRA, Drug Development News
Nitrosamines, TOPRA, & Drug Development News are the focus for our Q4 Industry Insights
Global Harmonisation of Clinical Trials
Global Harmonisation of Clinical Trials is the latest focus for our quarterly roundup of the regulatory landscape with news from EMA, FDA and ICH
Latest News in Clinical Development Practices and Regulations
Our latest Industry Insights focuses on Brexit and news from the regulators around the globe.
SME Day at the EMA – Part Two
Part Two of the report from the SME Day at the EMA focuses on Marketing Authorisations and more.
SME Day at the EMA – Part One
Larissa Gould reports from the EMA in Canary Wharf on the latest developments.
Brexit Update, Clinical Trial Data Sharing, & more
Our latest industry update covers news about Brexit, from FDA, EMA and more.
EMA, PhUSE, Bioforward and the latest Staff Update
Our staff and events teams are working hard, as we head towards the end of the year.
The Impact of Brexit on Pharmaceuticals in the UK – UPDATE
Stephen Thompson, our regulatory affairs Director, writes about the latest Brexit news.