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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