Module 1 2021

28/06/2021

In this presentation we will cover

• What advice do you need?

• Why seek advice?

• When should you seek advice?

• Where should you seek advice?

• How seek advice?

• What do you do with it?

The Organisation for Professionals in Regulatory Affairs

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When should you seek advice

• Development milestones • Early development pre-pre-IND/EMA- pre-assessment • First In Man • Proof of Concept - scientific advice/pre-IND • During development – EOP2, ad hoc • Pre-submission

• EOP3, pre-NDA/MAA • Accelerated pathways • Specific pathways – paediatric, orphan • Post-submission

• PIPs/PSPs, RMPs/REMS • Lifecycle management

Decision and process led by Regulatory Affairs?

The Organisation for Professionals in Regulatory Affairs

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