What are expedited reporting timelines? Question - 19 Pharmacovigilance Interview Questions by Ramya. Watch all Interview Questions [ Ссылка ] . To know more details visit [ Ссылка ]
Question - 19: What are expedited reporting timelines?
Time frames of expedited reports vary among countries, depending on the source, expectedness and outcome.
In general,
Expedited reporting of serious and unexpected ADRs from post-marketing sources is
required as soon as possible, but in no case later than 15 calendar days of
initial receipt of the information by the MAH.
Clinical trials fatal or life-threatening Unexpected ADRs: Fatal or life-threatening unexpected ADRs occurring in clinical
investigations, qualify for very rapid reporting. The regulatory agencies must be notified within 7
calendar days after first knowledge, by the sponsor, followed by a complete report within the next 8
days (i.e., 15 days after first knowledge of event).
All other serious, unexpected ADRs from clinical trials: Serious, unexpected ADRs that are not fatal or life-threatening,
must be filed within 15 calendar days after the first knowledge of the sponsor.
