Introduction to Pharmacovigilance

What Will You Learn?

• Understand the fundamentals of pharmacovigilance and its role in drug safety.
• Identify and classify different types of adverse drug reactions (ADRs).
• Learn about global regulatory frameworks, including guidelines from the FDA, EMA, and WHO.
• Gain practical skills in reporting adverse events and processing safety data.
• Apply risk management strategies, including signal detection and risk-benefit analysis.
• Analyze real-world pharmacovigilance case studies to understand industry practices.
• Communicate safety information effectively to stakeholders.

Material Includes

• Video lectures covering each module topic.
• Downloadable lecture notes and regulatory guidelines for reference.
• Infographics and visual aids on drug safety processes.
• Case studies and real-world examples of pharmacovigilance practices.
• Quizzes after each module to test comprehension.
• Interactive assignments based on real-world pharmacovigilance scenarios.
• Access to a discussion forum for peer interaction and Q&A.

Requirements

• No prior pharmacovigilance experience is required.
• Basic knowledge of healthcare or pharmaceuticals is helpful but not necessary.
• Active participation in quizzes and assignments is encouraged for optimal learning.
• A stable internet connection is recommended for streaming video content.
• Complete the final assessment to earn a certificate of completion.

Audience

• Healthcare professionals looking to enhance their understanding of drug safety.
• Regulatory affairs personnel responsible for compliance in pharmacovigilance.
• Pharmaceutical industry professionals involved in safety monitoring and reporting.
• Students and professionals entering the field of drug safety or regulatory affairs.
• Anyone interested in ensuring patient safety through effective pharmacovigilance practices.

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