Module 1 2021

25/06/2021

Little Excursion … Characteristics of Agile Management/ Environment • Functionality devolved over time in an iterative and incremental manner • Functionality broken down into small work packages • Scope and requirements might not be fully known at the beginning and evolve over time… • High need of adaptability and/or ability to required change • High need of communication/ collaboration • High visibility / transparency (regular updates) • Clear focus on value and prioritization (strategy!)

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

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RA Submission Planning

1. Prior to submission

2. After submission / during procedure

3. Upon grant of license/ approval

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

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