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GVP Module XVI Addendum II, E2D(R1), E2B(R3) mandates, and recent ICH/EMA revisions.
9 terms
EMA revision (2025) to GVP Module XVI on risk minimization; adds guidance on effectiveness evaluation of risk minimization measures and pregnancy prevention programmes.
ICH guideline (Step 4 Sept 2025) on post-approval safety data management; harmonizes definitions and handling of post-marketing ICSRs globally.
FDA requirement (April 2026) for structured electronic submission of adverse events in ICH E2B(R3) format; replaces older formats for FAERS.
Risk minimization programme to prevent fetal exposure (e.g., contraception, testing, education). GVP XVI Addendum II requires effectiveness evaluation.
Structured data elements in ICH E2B(R3) for ICSR (e.g., patient, reaction, drug, narrative). Mandatory for electronic submission.
Automated check that E2B(R3) message is well-formed and passes business rules before submission.
EMA guidelines on PV; modules cover system, reporting, signals, RMP, etc. Key reference for EU and global practice.
Revised GVP Module VI on collection and submission of reports; includes Addendum II on masking.
ICH guideline on safety data collection in trials (selective safety data collection).