Aggregate / Periodic Safety Reports
Mapi is experienced in the preparation of aggregate safety reports (ASR) in ICH E2C (R1) (PSUR), ICH E2C (R2) (PBRER), ICH E2F (DSUR), US Periodic Adverse Drug Experience Report and Canadian Annual Summary Report formats.
Mapi’s pharmacovigilance team is involved in multiple aspects of preparation of aggregate safety reports, including provision of data contributions such as adverse event listings and tabulations, medical writing, quality control and medical review. Mapi’s Strategic Regulatory Services support publishing activities as well as submission via eCTD, NeeS and traditional non-electronic pathways. Our services include:
- Tracking of reporting periods and submission dates;
- Identification of and obtaining all appropriate data;
- Identification and characterisation of Important Identified Risks, Important Potential Risks and Missing Information;
- Generation of tables & listings from safety database;
- Preparation of benefit-risk evaluation;
- Medical review of each report;
- Draft report for client review and approval;
- Publishing in eCTD or NeeS format;
- Submission to regulatory agencies and ethics committees;
- Distribution to stakeholders, e.g. commercial partners.