CASafetyReporting object
Responsible for AE reporting to CA
Sponsor
Sponsor must declare reportable events to
Competent Authority
Relevant EC(s)
Reportable AEs
SAE (Serious Adverse Event)
SUSAR (Suspected Unexpected Serious Adverse Reaction)
SUSAR being life-thereatening or leading to death must be reported
Within a max of 7d upon first knowledge (+ 8d for additional information)
All other SUSARs
Within a max of 15d upon first knowledge
Provision of Annual safety report mandatory
Yes
Annual safety report shall be provided by sponsor to
National CA
Relevant EC(s)
Guidance on AE reporting procedure available
Yes
Guidance on AE reporting procedure
Details on submission procedures are given in Circular n° 593 and Circular n° 586, provided on the FAMHP website in section: Human medicines > Medicines > Medicines > Research & Development > Clinical trials
Additional Information
The Belgian Centre for Pharmacovigilance for medicines for Human use (BCPH), that is part of the FAMHP, is responsible for the coordination of the different tasks related to pharmacovigilance.
Investigator shall report SAE to
Sponsor
Reporting timeline
Immediately
