Pharmacovigilance monitors the safety of a drug once it has been launched onto the market. It is the process which improves the safety of medicines. It detects medicines that cause serious adverse drug reactions (ADRs) and ensures they are re-evaluated or removed from the market to protect public health.

Our course will cover topics from basic pharmacovigilance principles and terminologies through to the current regulatory framework and its global impact. Proactive pharmacovigilance pre- and post-marketing will be addressed as will risk management, the challenges of causality assessments and effective signal detection.

This course use real-world examples and case studies to contribute to the development of your knowledge and there will also be ample opportunity to share experiences with the speakers and fellow professionals, which will further enhance the understanding of pharmacovigilance issues.

The British Academy for Training and Development offers this course to the following categories:

• Both new and long-term employees, as well as researchers, pharmaceutical industry suppliers, clinical trial personnel, and life science professionals.
• Professionals involved with various components of the pharmaceutical quality systems (PQS) including quality assurance/testing, quality risk management (QRM).

• Anyone with an interest in drug safety monitoring and/or drug research.

After completing the program, participants will be able to master the following topics:

• Understand the safety surveillance requirements for the safe use of pharmaceuticals (drug safety).
• Pre-marketing and post-marketing pharmaceutical product safety surveillance.
• Identify the adverse drug reactions recording and reporting requirements.
• Understand the serious adverse events (SAEs) reporting requirements in relation to pharmaceutical products, including investigational medicines, medical devices, and vitamin supplements.
• Understand ICH Pharmacovigilance guidelines.
• Identify the differences between ICH guidelines and TGA guidelines for Pharmacovigilance.

• Make examples of Pharmacovigilance guidelines.

• Principles of pharmacovigilance and data resources.
• Risk management.
• Pharmacoepidemiological studies.
• Proactive pharmacovigilance pre- and post-marketing, risk-benefit assessment.
• Pharmacovigilance regulations, clinical trial ADR reporting requirements.
• Drug surveillance.
• Post-marketing surveillance: observational cohort studies.
• An overview of signal detection and risk management plans (RMPs).