The British Academy for Training and Development offers this training program on Pharmacovigilance, aimed at enhancing the competencies of professionals in the pharmaceutical and medical sectors in monitoring, analyzing, and following up on adverse drug reactions in a scientific and systematic manner. This field is a fundamental pillar for ensuring patient safety, developing pharmaceutical policies, and reducing the risks associated with the improper use of medications.

The importance of pharmacovigilance has grown globally in recent years due to the accelerated production of drugs and the diversity of their sources. This calls for effective regulatory systems capable of keeping pace with these changes and ensuring the highest standards of drug safety. This program explores the latest methodologies used in drug safety reporting, evaluation, and data analysis, and offers a comprehensive vision for building an effective pharmacovigilance system within healthcare institutions, pharmaceutical companies, and regulatory bodies.

Who Should Attend?

• Pharmacists working in hospitals, health centers, and pharmaceutical companies.
• Physicians and healthcare professionals concerned with patient safety.
• Personnel from drug regulatory and oversight authorities.
• Professionals in research and development departments in the pharmaceutical industry.

Knowledge and Benefits:

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

• Understand the fundamental principles of pharmacovigilance and how to apply them.
• Evaluate reports related to adverse drug reactions.
• Comprehend the role of national and international regulatory bodies in monitoring drug safety.
• Enhance their ability to manage and analyze pharmacovigilance databases.
• Develop the skills to draft drug safety reports with accuracy and professionalism.

• Overview of Pharmacovigilance
  • Definition and objectives of pharmacovigilance
  • Historical context and key milestones
  • Importance in drug safety
• Regulatory Framework
  • Global regulatory bodies (FDA, EMA, WHO)
  • Key regulations and guidelines (ICH E2E, GVP)
  • Roles and responsibilities in pharmacovigilance
• Adverse Drug Reactions (ADRs)
  • Definition and classification of ADRs
  • Common types of ADRs
• Data Sources in Pharmacovigilance
  • Types of data sources (clinical trials, post-marketing surveillance)
  • Electronic health records and databases
  • Role of social media and patient reports
• Signal Detection
  • Definition and significance of signals
  • Methods for signal detection (statistical, qualitative)
  • Tools used in signal detection (SRS, database mining)
• Risk Management Plans (RMPs)
  • Components of a Risk Management Plan
  • Developing and implementing RMPs
  • Monitoring and evaluating RMP effectiveness
• Pharmacovigilance in Clinical Trials
  • Importance of pharmacovigilance during trials
  • Reporting requirements and responsibilities
• Best Practices in Pharmacovigilance
  • Strategies for effective pharmacovigilance
  • Collaboration among stakeholders (industry, regulators, healthcare providers)
  • Building a culture of safety in organizations
• Emerging Technologies in Pharmacovigilance
  • Role of artificial intelligence and machine learning
  • Data analytics and real-world evidence
  • The future of pharmacovigilance with technology