RQA GPvP Committee
with regard to your 2nd question Delayed submission (upgrade from non-serious to serious) :
The expedited reporting requirements start from the moment the company (or the contractor collecting the safety information locally) has received the particular follow-up information that would upgrade the event to serious or expedited IME.
Whilst the initial report date must not be changed in the database, when your company reports the upgraded ICSR to the HA it must be clear on which date the additional follow-up information was received which upgraded the seriousness. The company's triage and case duplicate checks should be set-up in such a way to identify such information, so that the due dates for expedited reporting can be met (e.g. 15 calendar days in EU/EEA countries).
We hope you found this information useful.