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Post-authorisation safety studies (PASS) | European Medicines Agency
A statement in support of EMA's clinical study report transparency policy | Cochrane
European Medicines Agency challenged to support better clinical trial reporting
Open Sharing of Clinical Trial Data | IntechOpen
Europe's EMA - Global Regulatory Partners, Inc.
Preferred Reporting Items for Systematic Reviews and Meta-Analyses... | Download Scientific Diagram
PDF) Assessment of Adverse Events in Protocols, Clinical Study Reports, and Published Papers of Trials of Orlistat: A Document Analysis
Anonymization and Redaction of Clinical Trials According to the EU Regulation
Clinical data publication | European Medicines Agency
Positive outcome for ema's policy 0070, one year after the publication of the clinical trial results - Portolano Cavallo
Good clinical practice | European Medicines Agency
What you Need and When – The Key Documents in the Drug Lifecycle - Trilogy Writing & Consulting GmbH
Accelerated Approval of Medicines: EU and US - BioProcess InternationalBioProcess International
EMA report on geographic distribution of clinical trials supports need for revision of European clinical trial legislation
PDF) Clinical study reports of randomised controlled trials: An exploratory review of previously confidential industry reports
Oseltamivir for influenza in adults and children: systematic review of clinical study reports and summary of regulatory comments | The BMJ
The European Medicines Agency Clinical Data Website Enables Insights I | OAJCT
What are the EMA Guidelines for Clinical Trial Management? – pepgra
The EU 536/2014 Clinical Trials Regulation to be applicable in 2 years from now (Oct20) ?
The European Medicines Agency Clinical Data Website Enables Insights Into Clinical Development Timelines And Strategy. - Document - Gale Academic OneFile
Post-authorization studies (PAS): European & American approach
EudraVigilance system overview | European Medicines Agency
Risk of bias in industry-funded oseltamivir trials: comparison of core reports versus full clinical study reports | BMJ Open