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.

• Definition of pharmacovigilance and its importance in health care.
• The goals of pharmacovigilance and its benefits to patients and society.
• Pharmacovigilance principles and data sources.
• Risk Management.
• Pharmacoepidemiology studies.
• Proactive pre- and post-marketing pharmacovigilance, risk-benefit assessment.
• Pharmacovigilance regulations, and requirements for reporting ADR results for clinical trials.
• Drug control.
• Post-marketing monitoring: observational studies.
• Overview of signal detection and risk management plans (RMPs)
• Basics of medicines.
• The concept of medicines and their different types.
• Identify pharmaceutical components and their effects on the body.
• Clarifying the sources of medicines and their distribution and marketing mechanisms.
• Foundations of drug safety.
• Drug interactions and side effects of medications.
• How to reduce the risks associated with the use of medications.
• Electronic pharmaceutical systems and their role in enhancing drug safety.
• Techniques for the correct use of medications.
• The importance of following prescribed doses and medical instructions.
• How to deal with expired or unused medications.
• Effective communication skills with patients and healthcare teams.
• How to exchange drug information clearly and accurately.
• Strengthening communication between all parties concerned with drug safety.
• Evaluate and monitor results.
• The importance of evaluating the effectiveness of drug treatment.
• Evaluation tools and standards used in the field of pharmacovigilance.
• How to analyze data and draw useful conclusions.
• Serious adverse events (SAEs) reporting requirements for pharmaceutical products.
• Differences between ICH and TGA pharmacovigilance guidelines.
• Study practical cases related to pharmacovigilance and solve related problems.
• Apply acquired concepts in real-life situations.