Module 1 2021

25/06/2021

Submission Planning (4)

3. Upon approval 

Reimbursement discussions (country specific – start even earlier)  Launch activities (need to be planned and prepared far ahead approval – to be ready on Day “X”)  PAC  Maintenance / LCM  Extension of Indications

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

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Practical Aspects - Some recommendations…

 Roles & Responsibilities: o clearly defined & assigned o get agreement & document accordingly

 Project Plan, Submission Planning document # → living documents → easy to understand & accessible for the team concerned o start at the development state with the goal in mind o document major decisions & last-minute changes o consider rapid changes of regulatory environment & competitor environment  any changes (incl. long term) evaluate consequences  Change Controls  Schedule (e.g. Gantt Chart) : include dependencies of individual tasks

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

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