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Post-authorisation safety studies and the EU PAS Register, ENCePP ...

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Content of <strong>the</strong> presentation<br />

1. <strong>PAS</strong>S: definition <strong>and</strong> objectives (a reminder)<br />

2. Obligations <strong>and</strong> recommendations<br />

3. The <strong>EU</strong> <strong>PAS</strong> <strong>Register</strong><br />

4. Guidance for <strong>PAS</strong>S protocol submission<br />

1

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