Spring Intro 2023

16/02/2023

Top Tips

Keep on top of the schedule Amendments to the EURD list may be requested, however: ● Propose changes as early as possible, dates are legally binding once published Consider submitting safety labelling updates w/PSUR vs type II variation PSUR writing usually kicks off ~6 weeks prior to DLP Responses to questions: ● Prepare team for fast turn around of questions (~1 month) during procedure ● Negotiate response timeframes – can responses be submitted with next PSUR? (esp. 6-monthly schedules)

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SAFETY: - Risk Management Plans (RMPs) including risk minimization measures (RMMs) and Direct Healthcare Professional Communications (DHPCs)

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