EMA’s Revised Guide On Additional Risk Minimization ‘Overly Detailed’
EU Pharma Association Pushes For Greater Use Of Digital Formats
Executive Summary
Executive Summary: The European pharma industry federation believes the advice provided in the updated draft EU guideline on additional risk minimization measures is far too detailed, resulting in a lack of focus, information overlap and confusion.
You may also be interested in...
EMA To Consider How To Deliver Drug Risks Information Via Digital Formats
European Medicines Agency plans to finalize changes to its guideline on additional risk minimization measures and then establish a new drafting group on digitalization of education materials.
EMA To Beef Up Guidance On Additional Risk Minimization Tools
Based on its experience of reviewing tools used by companies for additional risk minimization, the European Medicines Agency is planning to update its guidance on this topic with more information on how these tools can be better employed.
Simplified Clinical Trial Transparency Rules To Go Live In The EU In June
A new version of the EU Clinical Trials Information System’s public portal will integrate the functionalities of the streamlined transparency rules.