Introduction

In an ever-evolving pharmaceutical landscape, ensuring the safety of medicinal products is paramount. As new drugs are developed and existing ones are used more widely, the need for robust systems to monitor their effects on patients has never been more critical. Pharmacovigilance, the science of collecting, assessing, and preventing adverse drug reactions, is a cornerstone of modern public health. This specialized training course provides professionals with a comprehensive understanding of the principles and practices that govern drug safety from clinical trials through post-market surveillance. This program is designed to meet the growing demand for skilled professionals in the field of drug safety. Participants will gain practical knowledge of global regulatory frameworks, learn how to identify and report adverse events, and master the use of essential tools and databases. The curriculum emphasizes a proactive approach to risk management and communication, preparing attendees to play a vital role in protecting patient health and maintaining the integrity of pharmaceutical products throughout their lifecycle.

Duration:

5 days

Target Audience:

• Pharmacovigilance associates and officers
• Clinical research associates
• Drug safety physicians
• Regulatory affairs specialists
• Pharmacists and nurses
• Quality assurance professionals
• Medical writers
• Pharmaceutical and biotech professionals
• Data managers in the life sciences
• Clinical trial investigators

Objectives:

• Master the core principles and scope of pharmacovigilance.
• Understand global regulatory requirements for drug safety reporting.
• Identify and classify different types of adverse drug reactions (ADRs).
• Learn the complete process of an Individual Case Safety Report (ICSR).
• Utilize key safety databases for signal detection and analysis.
• Understand the role of risk management and communication.
• Gain a practical understanding of pharmacovigilance in clinical trials.
• Comprehend the importance of quality management systems in PV.
• Discuss the future trends and technologies in drug safety.

Module 1: Introduction to Pharmacovigilance

• Definition and key terminologies in PV
• The history and importance of drug safety
• Roles and responsibilities of a PV professional
• The global network of pharmacovigilance centers
• The purpose of a PV system

Module 2: Regulatory Frameworks and Guidelines

• Overview of global PV regulations (e.g., FDA, EMA, ICH)
• Understanding Good Pharmacovigilance Practices (GVP)
• The role of local and national health authorities
• Key PV guidelines (e.g., ICH E2 series)
• Compliance and auditing in a PV environment

Module 3: Adverse Drug Reactions (ADRs)

• Defining adverse events (AEs) and ADRs
• Classification of ADRs by severity and causality
• Common types of drug-related problems
• The importance of causality assessment
• Using causality assessment scales like Naranjo

Module 4: Case Processing and Reporting

• The Individual Case Safety Report (ICSR) lifecycle
• Data collection and case intake methods
• Data entry and coding using MedDRA and WHO-DD
• The process of case follow-up and validation
• Submission of ICSRs to regulatory bodies

Module 5: Signal Detection and Management

• The concept of a safety signal
• Methods for signal detection (data mining, spontaneous reports)
• The five steps of signal management
• Investigating and confirming safety signals
• Reporting safety signals to regulatory authorities

Module 6: Risk Management and Communication

• Introduction to Risk Management Plans (RMPs)
• Key components of an RMP
• Risk communication to healthcare professionals and patients
• The role of Periodic Safety Update Reports (PSURs)
• Post-marketing surveillance and risk minimization

Module 7: Pharmacovigilance in Clinical Trials

• The role of drug safety in early phase clinical trials
• Managing and reporting adverse events during a trial
• The difference between pre- and post-marketing PV
• Unblinding and reporting of serious adverse events
• Data integrity and quality in clinical safety

Module 8: Quality Management and Future Trends

• Developing a robust Quality Management System (QMS)
• Audits and inspections in pharmacovigilance
• The impact of technology (AI, machine learning) on PV
• The future of drug safety and personalized medicine
• Ethical considerations in pharmacovigilance

Training Approach

This course will be delivered by our skilled trainers who have vast knowledge and experience as expert professionals in the fields. The course is taught in English and through a mix of theory, practical activities, group discussion and case studies. Course manuals and additional training materials will be provided to the participants upon completion of the training.

Tailor-Made Course

This course can also be tailor-made to meet organization requirement. For further inquiries, please contact us on: Email: info@skillsforafrica.org, training@skillsforafrica.org  Tel: +254 702 249 449

Training Venue

The training will be held at our Skills for Africa Training Institute Training Centre. We also offer training for a group at requested location all over the world. The course fee covers the course tuition, training materials, two break refreshments, and buffet lunch.

Visa application, travel expenses, airport transfers, dinners, accommodation, insurance, and other personal expenses are catered by the participant

Certification

Participants will be issued with Skills for Africa Training Institute certificate upon completion of this course.

Airport Pickup and Accommodation

Airport pickup and accommodation is arranged upon request. For booking contact our Training Coordinator through Email: info@skillsforafrica.org, training@skillsforafrica.org  Tel: +254 702 249 449

Terms of Payment: Unless otherwise agreed between the two parties’ payment of the course fee should be done 7 working days before commencement of the training.