Spring Intro 2023
16/02/2023
What a PIP looks like
Cover letter
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Pre-specified content; no longer mandatory
Part A
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(Long) administrative application form
PIP proposals with detailed scientific and regulatory justification
Parts B-E
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• Summary of PIP commitments • Basis of EMA PIP Decision • Basis of compliance check • Represents your (future) legal obligations
Key binding elements form
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References
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Pdfs of cited literature
• Administrative delegations • IB • Scientific advice letters • Etc…
Annexes
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The Organisation for Professionals in Regulatory Affairs
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PIP submission and review
Submit via Syncplicity portal
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Validation process
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• Day 30 Summary Report (for information)
• Day 60 Request for Modification
Allow a year for this “120 day” process
Clock-stop
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• Day 90 Summary Report (for information)
Day 120 Opinion
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EMA Decision
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The Organisation for Professionals in Regulatory Affairs
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