A medication that works safely for thousands of patients can still cause a dangerous reaction in the next one — and catching that risk early, before it becomes a public health issue, is the entire point of pharmacovigilance. As drug production accelerates and supply chains diversify globally, the systems that monitor, analyse and act on adverse drug reactions have become just as critical as the drugs themselves. The Arab British Fellowship Training Academy built this course to prepare pharmaceutical and medical professionals for exactly that responsibility.

Participants explore how adverse reactions are detected and reported, how regulatory bodies oversee drug safety internationally, and how to build and manage a risk management plan inside a hospital, pharmaceutical company or regulatory body. The course closes by looking at how artificial intelligence and data analytics are starting to reshape how safety signals get caught in the first place.

Who Should Attend?

• Pharmacists working across hospitals, health centres and pharmaceutical companies.
• Physicians and healthcare professionals focused on patient safety.
• Staff at drug regulatory and oversight authorities.
• Research and development professionals within the pharmaceutical industry.

Knowledge and Benefits:

By the end of the course, participants will be able to:

• Apply the fundamental principles of pharmacovigilance in practice.
• Evaluate reports of adverse drug reactions with a systematic approach.
• Understand how national and international regulatory bodies oversee drug safety.
• Manage and analyse pharmacovigilance databases effectively.
• Draft accurate, professional drug-safety reports.

Module 1: Why Pharmacovigilance Matters for Patient Safety

• What pharmacovigilance is, and how it developed into its current form.
• Why it has become a critical pillar of patient safety and pharmaceutical policy.

Module 2: Understanding Adverse Drug Reactions (ADRs)

• Defining and classifying adverse drug reactions.
• The most common types of ADRs encountered in practice.

Module 3: Where Pharmacovigilance Data Comes From

• Data sources such as clinical trials and post-marketing surveillance.
• The growing role of electronic health records, databases, social media and patient-reported data.

Module 4: Detecting Safety Signals

• What a safety signal is, and why early detection matters.
• Statistical and qualitative methods for signal detection, and the tools used, such as spontaneous reporting systems and database mining.

Module 5: Building and Managing Risk Management Plans (RMPs)

• The core components of a Risk Management Plan.
• Developing, implementing and monitoring an RMP's effectiveness over time.

Module 6: Pharmacovigilance Inside Clinical Trials

• Why pharmacovigilance matters throughout a clinical trial.
• Reporting requirements and responsibilities during trials.

Module 7: The Regulatory Framework Behind Drug Safety

• Global regulatory bodies such as the FDA, EMA and WHO.
• Key regulations and guidelines, including ICH E2E and GVP, and how roles and responsibilities are distributed across the system.

Module 8: Best Practices, Safety Culture and Emerging Technologies

• Strategies for effective pharmacovigilance and collaboration between industry, regulators and healthcare providers.
• Building a culture of safety within organisations.
• How artificial intelligence, machine learning and real-world data analytics are shaping the future of pharmacovigilance.