MHRA Draft Guidance on Randomised Controlled Trials Generating Real-World Evidence to Support Regulatory Decisions
The MHRA have drafted new guidance providing points to consider [...]
ITALY – Increasing Need for a New Legislation to Facilitate Execution of Observational Studies
In the last decade scientists conducting observational studies in Italy [...]
France’s Health Data Hub to Move to European Cloud Infrastructure to Avoid EU-US Data Transfers
France’s data regulator CNIL has issued some recommendations for French [...]
Real World Data (RWD) in Times of Change
The impact of COVID-19 is a black swan event or [...]
FDA Launches the Digital Health Center of Excellence
Recently, the U.S. Food and Drug Administration announced it is [...]
Revision 3 of GVP Module VIII (EMA)
Revision 3 of GVP Module VIII Addendum I – Requirements [...]
Real World Evidence: From Activity to Impact in Healthcare Decision Making
Real-world evidence could significantly improve healthcare decisions across the health [...]
Eighth Revision of the ENCePP Guide on Methodological Standards in Pharmacoepidemiology Published
The 8th revision of the ENCePP Methods Guide has been published [...]
Announcing the Real World Study Document Index (RWS-DI)
Why is a stand alone index needed? Those of you [...]
Pharma’s Investment In RWE Is Beginning To Pay Off
Companies that have invested in mature RWE capabilities are seeing [...]