Certification in Regulatory Affairs
Master global drug-safety regulations and hands-on safety reporting. This program covers ICH E2 guidelines, CIOMS recommendations, FDA/EMA/Indian safety requirements, expedited and periodic reporting, EVMPD, FAERS/EudraVigilance submissions, and label-change tracking—exactly what PV teams do in industry. Advancing Your Career with Expert Pharmacovigilance Regulations Training
“Master ICH E2A–E2F and CIOMS guidance, meet FDA/EMA/CDSCO reporting rules, and practice FAERS & EudraVigilance submissions, EVMPD updates, and CCDS/label-change tracking.”
This certification focuses on drug-safety regulations and real-world reporting. You’ll learn what/when/how to report in clinical and post-marketing/BA-BE studies, submission pathways (Gateways/FAERS/EudraVigilance and manual in India), and how to track innovator label updates and implement CCDS changes—all aligned to current PV expectations. What You Will Learn in Regulatory Affairs Training
This course builds practical competence in applying ICH E2A–E2F and CIOMS guidance to real-world drug-safety work. You’ll learn what/when/how to report across clinical and post-marketing (including BA/BE), meet FDA, EMA (GVP), and India PvPI/Schedule-Y requirements, and practice end-to-end safety submissions.
You’ll practice preparing expedited and periodic reports (ICSR, PSUR/DSUR), submitting via FAERS/EudraVigilance, maintaining EVMPD entries, and tracking innovator label changes to update CCDS—exactly what PV teams deliver in industry.The regulatory Affair course will give you a good understanding of regulatory guidelines various regulatory authorities provide.
By the end, you’ll confidently interpret global PV rules and execute compliant safety reporting across major regions.
PV Safety Terminology & Foundations
Master core PV terms and decisions: case intake, seriousness, expectedness, causality, MedDRA basics, and how ICH E2A/E2D/E2F drive daily safety work.
Global Frameworks: ICH/CIOMS & Regional Rules
Apply ICH E2A–E2F and CIOMS recommendations; map requirements across FDA, EMA (GVP), and CDSCO/PvPI for clinical and post-marketing (incl. BA/BE).
ICSR Reporting: Expedited & Periodic
Decide what/when/how to report; structure E2B(R3) data elements and narratives; understand PSUR vs DSUR and region-specific timelines & formats.
Submissions & Systems: FAERS, EudraVigilance & EVMPD
Practice Gateway/portal workflows, validation rules, and reconciliation; maintain EVMPD data; ensure 21 CFR Part 11 readiness and audit trails.
Labeling & Regulatory Intelligence (Hands-on)
Track innovator label changes, update CCDS, and monitor FDA/EMA/HMA/Lareb sites; compile change justifications and impact assessments.
