Скачать или смотреть Pharmacovigilance Safety Monitoring in Clinical Trials | Regulatory Affairs

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Pharmacovigilance & Safety Monitoring in Clinical Trials play a crucial role in detecting, assessing, and preventing adverse drug reactions (ADRs) and ensuring patient safety. Continuous monitoring of drug safety during clinical trials helps identify potential risks early, allowing regulatory authorities to take necessary actions. In this video, we’ll explore how pharmacovigilance ensures the safety of investigational drugs and protects trial participants.

What You’ll Learn:

• What pharmacovigilance is and its role in clinical trials.
• Key safety monitoring processes, including adverse event (AE) and serious adverse event (SAE) reporting.
• The importance of risk assessment and risk management in drug development.
• Regulatory guidelines for pharmacovigilance (ICH-GCP, FDA, EMA, CDSCO, WHO).
• How safety data is collected, analyzed, and reported during clinical trials.

This video is essential for pharmacy students, clinical researchers, and regulatory professionals who want to understand how drug safety is monitored throughout the clinical trial process.

If you find this video informative, don’t forget to like, comment, and share it with your peers to spread awareness about pharmacovigilance and its significance in clinical trials!

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