Global Pharmacovigilance Compliance: Building Effective Safety Governance in Modern Pharmaceutical Organizations

Abstract

Global Pharmacovigilance Compliance: Building Effective Safety Governance in Modern Pharmaceutical Organizations

Objectives:

1. Understand the core principles of global pharmacovigilance compliance and patient safety
governance in pharmaceutical organizations.
2. Explore international pharmacovigilance regulations, reporting systems, and global safety
monitoring frameworks.
3. Examine quality management systems, risk management strategies, and regulatory compliance
practices in drug safety operations.
4. Analyse adverse event reporting, signal detection, aggregate reporting, and modern
pharmacovigilance workflows.
5. Evaluate the impact of digital transformation, artificial intelligence, and data-driven
technologies on future safety governance.

Table of Contents

CHAPTER 1 Foundations of Global Pharmacovigilance: History, Scope, and

Importance

CHAPTER 2 The Regulatory Landscape: Navigating ICH Guidelines and

International Standards

CHAPTER 3 The Qualified Person Responsible for Pharmacovigilance:

Leadership and Liability

CHAPTER 4 Standard Operating Procedures: Drafting the Blueprint for

Compliance

CHAPTER 5 Individual Case Safety Reports: Mastering the Lifecycle of

Adverse Events

CHAPTER 6 Aggregate Safety Reporting: Synthesizing Data for PSURs and

PBRERs

CHAPTER 7 Signal Detection and Management: Identifying Emerging Risks in

Real-Time

CHAPTER 8 Risk Management Plans and REMS: Proactive Safety

Interventions

CHAPTER 9 The Pharmacovigilance System Master File: Maintaining the

Golden Record

CHAPTER 10 Quality Management Systems: Driving Excellence through

Continuous Improvement

Global Pharmacovigilance Compliance: Building Effective Safety Governance in Modern Pharmaceutical Organizations 2
CHAPTER 11 Internal Audits and Regulatory Inspections: Preparing for the

Ultimate Test

CHAPTER 12 Managing Third-Party Compliance: PV Agreements and Vendor

Oversight

CHAPTER 13 Pharmacovigilance in Emerging Markets: Adapting to Diverse

Local Requirements

CHAPTER 14 The Digital Transformation: Harnessing AI and Big Data in Safety

Governance

CHAPTER 15 Building a Culture of Safety: The Future of Global

Pharmacovigilance Governance