Module 1 2021

25/06/2021

Submission Planning - RA Environment

• Tight & defined authority deadlines (challenge: parallel filings) • Potentially huge impact (on e.g., safety, commercial/ business, compliance, reputation, financially etc. ) • Full scope might not be fully clear at the beginning –impact on potential requirements, scope and time (SA) • Highly visible and sensitive within the organization • Tend to involve significant costs (new approach/ solutions) [11]

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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 (1)

1. Prior to submission

 Global filing strategy o US, EU, Japan, ROW

 Pre-submission activities?  Prerequisites available?  Procedural aspects o timetables? o receipt of questions o strategic considerations o clock stops, one global dossier o communication between authorities?

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

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