Program Overview

This comprehensive GVP training program delivers a practitioner-level understanding of global pharmacovigilance (PV) requirements. Participants learn to manage adverse event reporting, expedited ICSRs, periodic safety reports (PSUR/PBRER/DSUR), signal detection, MedDRA coding, and risk management – aligned with FDA (21 CFR 312/314), ICH (E2A, E2B(R3), E2C, E2D, E2E, E2F), EU GVP modules, and Canadian GVP guidelines.

Global Pharmacovigilance and Safety Reporting I GVP Trainings

What is GVP? (Good Pharmacovigilance Practices)

Good Pharmacovigilance Practices (GVP) are a set of legally binding and guidance measures that ensure the ongoing safety monitoring of medicinal products throughout their lifecycle. GVP defines how pharmaceutical companies, marketing authorization holders (MAHs), and regulatory authorities should collect, assess, manage, and report adverse drug reactions. In simple terms, GVP is the rulebook for drug safety surveillance – from clinical trials to post-market use.

• 🔍 Key objective: Detect, assess, understand, and prevent adverse effects or any drug-related problem.
• 🌍 Global adoption: The EU GVP modules (e.g., Module V – Risk Management, Module VI – ICSR reporting, Module IX – Signal Management) set the benchmark. Similar frameworks exist under FDA (21 CFR) and ICH guidelines.
• 📋 What GVP covers:
  • Individual Case Safety Report (ICSR) processing & expedited timelines
  • Periodic safety reports (PSUR, PBRER, DSUR)
  • Signal detection & risk management plans
  • Risk minimisation (routine + additional measures)
  • Pharmacovigilance system master files (PSMF) & inspections
  • Safety communication to healthcare professionals and patients

Without robust GVP, patient safety is compromised, and regulatory non-compliance can lead to fines, product withdrawal, or criminal liability. Our training equips you with real-world GVP implementation skills across the US, EU, Canada, and ICH regions.

Key Learning Objectives

By completing this program, you will be able to:

• ✅ Differentiate adverse events (AE) from adverse drug reactions (ADR) and apply seriousness criteria
• ✅ Apply 7-day and 15-day expedited ICSR reporting rules, including correct “day zero” calculation
• ✅ Prepare and submit PSURs, PBRERs, and DSURs with global submission timelines
• ✅ Perform signal detection and risk management planning using ICH E2E principles
• ✅ Code adverse events using MedDRA and use Standardised MedDRA Queries (SMQs)
• ✅ Establish a compliant pharmacovigilance system (SOPs, training, recordkeeping, inspection readiness)

Target Audience

Certification

Participants who pass all module‑level assessments with ≥80% receive the “Global Pharmacovigilance and Safety Reporting Mastery” certificate – a validated credential demonstrating expertise in ICSR processing, periodic reporting, and signal management.

Core Modules (Highlights)

1. Foundations of Pharmacovigilance – AE vs ADR, seriousness criteria, minimum ICSR elements
2. Expedited ICSR Reporting – 7/15‑day timelines, day zero, unblinding, spontaneous vs solicited reports
3. Periodic Safety Reporting – PSUR, PBRER, DSUR; International Birth Date (IBD); DIBD; 70‑90 day submission rules
4. Signal Detection & Risk Management (ICH E2E) – Safety Specification, PRR/Bayesian methods, Pharmacovigilance Plan
5. MedDRA Coding & SMQs – Hierarchical levels (SOC, HLGT, HLT, PT, LLT), multi‑axiality, narrow/broad scope queries
6. PV Systems & Inspections – SOPs, contractual agreements, 25‑year record retention (Canada), Risk 1/2/3 classifications
7. Post‑Marketing ADE Reporting (21 CFR 314.80) – 15‑day alerts, quarterly/annual periodic reports, 10‑year record retention
8. IND Safety Reporting (21 CFR 312.32) – 7‑day fatal/LT reports, 15‑day serious unexpected, reasonable possibility
9. Canadian GVP Requirements – 15‑day serious ADR reports, annual summary reports, unusual failure in efficacy
10. EU GVP & Risk Minimisation – Module V (RMP), Module XVI (routine/additional measures), effectiveness evaluation

Global Pharmacovigilance and Safety Reporting I GVP Trainings

Real‑World Case Studies Included

• Missed Seriousness Determination (emergency room visit = serious)
• Day Zero Calculation Error (initial receipt vs final classification)
• Overdue DSUR (annual requirement even when trials are inactive)
• Missed Signal (tendon rupture in older people on corticosteroids)
• Inconsistent MedDRA Coding (investigation terms vs diagnosis)
• The 7‑Day Report that Wasn’t (life‑threatening without death)
• 25‑Year Record Retention Violation (Canada)
• Inadequate Risk Minimisation Evaluation (pregnancy prevention program)

Why Choose GxP Trainings?

• 🧠 Expert‑designed curriculum – Aligned with global regulatory expectations
• 📘 Practical, case‑driven learning – Not just theory
• 🎓 Certification – Demonstrates practitioner‑level competence
• 🌍 Corporate & group training – Tailored on‑site or virtual sessions for your team
• 📧 Dedicated support – info@gxptrainings.com

Courses Archive – GxP Trainings

Contact for Corporate & Group Training

📍 Email: info@gxptrainings.com
📍 Subject line: “GVP Corporate Training Inquiry”

We offer flexible schedules, discounted group rates, and customized content for MAHs, CROs, and regulatory departments.

Equip your team with globally compliant pharmacovigilance skills – contact us today.