Spring Intro 2023

16/02/2023

Considerations & Tips

How are they submitted? ● Type II variation (90 day review for changes to or addition of a new indication) Is the change compelling? ● Will change make a difference to patients? ● Are the changes supported by direct data / extrapolation / literature? Is the story clear?

● Consider a pre-submission meeting ● Documents straightforward & concise ● Make easy for reviewer to approve ● Transparency – Discuss challenges & reassure assessors

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Top Tips

• Good Project Management - Lead your team through the procedure: ●Set expectations, minimise surprises, e.g. have a risk log ●Prepare & plan proactively, start responses on receipt of Draft ARs ●Highlight intensive periods, submission prep & review, comment resolution, response preparation & review, SAG, OE – Resources ●Cost & operational efficiencies – can any variations be grouped? ●Working Documents should contain M2 documents as well as track changes of labelling updates and validation checklist ●Translations - Prepare affiliates / vendors for fast turnaround e.g. 5 calendar days

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