Spring Intro 2023

16/02/2023

Top Tips

Structure of assessment : ● Type II - 60 or 30 day timetable? ● Should it be a Type II 30 day or Urgent Safety Restrictions? Consider impact to: Clinical Trial Applications (CTAs) (inclusion/exclusion criteria, RSI) EU PI, RMP, Educational tools, DHPC (Direct Healthcare Professional communication) letter Keep good records – important for inspections! ● Differences between company position and the approved PI ● Global heath authority request & response tracker

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SAFETY: - Periodic Safety

Update/Benefit Risk Evaluation Reports (PSURs/PBRERs)

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