What You Will Learn

This course covers the essential concepts of pharmacovigilance. You will learn about the phases of clinical trials and the processes involved in monitoring drug safety.

Phases of Clinical Trials: You will understand the four main phases:

• Phase I: Focus on safety and dosage with healthy volunteers.

• Phase II: Assess efficacy and side effects with patients.

• Phase III: Confirm results on a larger scale and compare with standard treatments.

• Phase IV: Involves post-marketing surveillance to monitor long-term effects.

You will explore key components that are crucial in clinical trials:

• Protocol: A study plan that outlines the design of the trial.

• Informed Consent (ICF): The process ensuring patients agree to participate.

• Ethics Committee (IEC): Protects the rights of patients involved in the trials.

• Good Clinical Practice (GCP): Standards ensuring ethical and scientific quality.

Additionally, you will learn about Adverse Drug Reactions (ADRs):

• Definition: Any harmful or unintended response to a drug at normal doses.

• Types of ADRs: Understand Type A (Augmented) and Type B (Bizarre) reactions.

The course will guide you through the ADR reporting process:

• Identifying the ADR.

• Collecting details about the patient and drug.

• Filling out the ADR form (ICSR).

• Submitting reports to the pharmacovigilance center or regulatory authority.

You will also learn about causality assessment using:

• WHO-UMC Scale.

• Naranjo Algorithm.

Finally, you will become familiar with important pharmacovigilance terms:

• ICSR: Individual Case Safety Report.

• SUSAR: Serious Unexpected ADR.

• Signal Detection: The process of identifying safety signals.

This structured progression will help build your understanding from basic concepts to more advanced topics in pharmacovigilance.