GLOBAL | New HARPER Protocol Template for RWE Studies
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GERMANY | New Version of the BfArM-PEI Joint NIS Recommendations
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USA | FDA Announces New Funding Opportunity for Using Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making
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GERMANY | New AKEK Checklist for PMCF Study Submission Documents
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EU | Substantial modification Documents for Performance Studies under Regulation (EU) 2017/746
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EU | Performance Study Application/Notification Documents Under Regulation (EU) 2017/746
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EU | Guidance on Periodic Safety Update Reports (PSURs) According to the EU MDR
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CANADA | The Difference Between Clinical and Behavioural Studies
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USA | Revised FDA Guidance on Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers
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