Pharmacovigilance monitors the safety of a drug once it has been launched onto the market. It is the process that 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 at the British Academy For Training And Development will cover topics from basic pharmacovigilance principles and terminologies 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 uses real-world examples and case studies to contribute to the development of your knowledge. There will also be ample opportunity to share experiences with the speakers and fellow professionals, further enhancing 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.

• Introduction to Pharmacovigilance:

  • Definition and importance of pharmacovigilance.
  • History and evolution of the field.
  • Goals and benefits of pharmacovigilance for patients and society.
  • Principles of pharmacovigilance and data sources.

• Pharmacovigilance Systems and Techniques:

  • Types of pharmacovigilance systems.
  • How to collect and analyze data.
  • Role of organizations like the FDA and EMA.

• Designing and Managing Pharmacovigilance Studies:

  • How to design studies for monitoring adverse effects.
  • Strategies for selecting study samples.
  • Data collection and documentation techniques.
  • Using statistical software for data analysis.

• Risk Assessment and Management:

  • Overview of signal detection plans and Risk Management Plans (RMPs).
  • How to assess drug safety.
  • Managing risks associated with medications.
  • Methods for evaluating and managing drug-related risks.
  • How to apply risk management techniques in pharmacovigilance.

• Reporting Adverse Events:

  • How to report side effects.
  • Systems used for reporting.
  • Reporting systems for adverse effects (e.g., VAERS).

• Important Techniques and Skills:

  • Techniques for the correct use of medications.
  • Importance of following prescribed dosages and medical instructions.
  • How to handle expired or unused medications.
  • Skills for effective communication with patients and healthcare teams.
  • How to exchange drug information clearly and accurately.
  • Enhancing communication among all parties involved in drug safety.

• Critical Analysis and Evaluation:

  • How to evaluate the effectiveness of pharmacovigilance programs.
  • Analyzing case studies and practical applications.
  • Evaluating and monitoring outcomes.
  • Understanding the importance of evaluating the effectiveness of drug therapy.
  • Explaining evaluation tools and standards used in pharmacovigilance.

• Ethics in Pharmacovigilance and Modern Trends:

  • Ethical principles related to pharmacovigilance.
  • Patient rights and principles of transparency.
  • Modern trends in pharmacovigilance and information technology.
  • The use of technology and artificial intelligence in pharmacovigilance.
  • New developments in databases and global systems.

• Workshops and Practical Applications:

  • Workshops for analyzing real data.
  • Case studies for discussing the application of concepts.