Cases address Naranjo and WHO-UMC causality assessment algorithm application, Individual Case Safety Report (ICSR) E2B submission requirements, signal detection using disproportionality analysis and ROR calculation, risk management plan (RMP) development, expedited and periodic safety reporting timelines, product recall procedures, and medication error versus ADR classification. CDSCO, EMA, and FDA reporting requirements are compared throughout.

To develop systematic ADR recognition, causality assessment, signal detection, and evidence-based ICSR reporting and regulatory compliance competency for the full range of pharmacovigilance and drug safety practice.

The “Pharmacovigilance & Drug Safety Case Discussions” is designed for healthcare professionals, students, and educators seeking to deepen their clinical reasoning through structured case discussions in pharmacovigilance & drug safety.

Whether you are a specialist clinician deepening their clinical expertise, a resident building clinical competency, a student preparing for examinations, or an educator developing teaching materials — this programme provides evidence-based case discussions to meet your learning goals in pharmacovigilance & drug safety.

Certificates for TerraLeap programmes are issued and signed by authorised TerraLeap representatives. For programmes delivered in collaboration with universities, institutions, or industry organisations, certificates are jointly issued and co-signed by authorised representatives of both TerraLeap and the respective partner.

Each certificate carries a unique Certificate ID and QR code to enable instant authenticity verification — making it easy to share with employers, licensing bodies, or professional networks as evidence of your learning.