Post-authorisation safety studies and the EU PAS Register, ENCePP ...
Post-authorisation safety studies and the EU PAS Register, ENCePP ...
Post-authorisation safety studies and the EU PAS Register, ENCePP ...
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2. Obligations <strong>and</strong> requirements<br />
legal obligation recommended in <strong>the</strong> GVP optional<br />
Management of study<br />
St<strong>and</strong>ard format of protocol <strong>and</strong> study report<br />
PRAC oversight<br />
Registration of study in <strong>EU</strong> <strong>PAS</strong> register<br />
Study not to promote medicinal product<br />
Restricted payment to HCP<br />
Quality systems<br />
<strong>ENCePP</strong> methodological st<strong>and</strong>ards<br />
<strong>ENCePP</strong> checklist for study protocol<br />
<strong>ENCePP</strong> CoC<br />
<strong>ENCePP</strong> seal<br />
<strong>PAS</strong>S with MAH involvement<br />
Imposed as an<br />
Conducted voluntarily<br />
obligation<br />
<br />
<br />
<br />
(if in RMP)
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