Module 1 2021

25/06/2021

Submission Planning (2)

1. Prior to submission

Dossier (format) requirements? o New License Application/ Life-Cycle Activity? Legacy docs? Still state of the art? Compliance with current regulations? Format requirements? o region/country specific extras o Work Break Down: source documents & CTD sections or other related documents incl. dependencies o Track identified gaps during creation  Publishing requirements? o QC o Use of portals? o Print outs?

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The Organisation for Professionals in Regulatory Affairs The Organisation for Professionals in Regul tory Affairs

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Submission Planning (3)

2. After submission / during procedure  Positive validation? o Yes: start of procedure o No: provide requested data/ info (team availability!)  Gap analysis, generate data upon identification  Response strategy & process o Consider clarification meeting(s) with regulators o Oral Explanation/ Hearing? o Labelling negotiations  End of procedure (translations, closing sequence, review of official communication (confidentiality)  Share outcome (e.g. commitments)

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The Organisation for Professionals in Regulatory Affairs The Organisation for Professionals in Regul tory Affairs

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