Module 1 2021

25/06/2021

RA Project Management

RA Plan [3]

Project Management Plan [9]

… is the process of defining, preparing, and coordinating all plan components and consolidating them into an integrated project management plan. … comprehensive document that defines the basis of all project work and how the work will be performed.

… is a document that describes the specific steps and action required to successfully meet the regulatory strategy objectives. It contains specific elements required to assemble the regulatory submission. Some key components …

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

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RA Project Planning Some considerations ….

A good plan is key for successful & profitable projects (incl. timelines, resources, roles & responsibilities …)  Overall strategy vs project (specific) aim o Product development roadmap/ Target Product Profile o Authority feedback (SA, pre-submission meetings, etc.) o Regulations, Directives, Guidelines, etc.

o Risk Management / Risk-taking o Commercial/ business needs o Post-approval LCM activities

 Decision Tree Diagrams o Simple tool to document decisions o Most important document decisions (no matter what tool)

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

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