Module 1 2021

28-6-2021

Why a Regulatory Strategy?

• Understand the regulatory landscape • Guidelines • Stakeholders • Emerging policies • Precedences – Public assessment reports • Drive the development and identify hurdles so they can be solved proactively

The Organisation for Professionals in Regulatory Affairs

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Why a Regulatory Strategy?

Tracking tool: summarize key objectives/agreements with project team (target product profile) and with authorities Planning tool: documentation, timelines and topics to be discussed with health authorities Risk management: keep track of issues that may affect timelines, costs or commercial value

The Organisation for Professionals in Regulatory Affairs

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