IMPD | Investigation of Medicinal Product Dossier | Regulatory Affairs

Link for complete syllabus:    • Regulatory Affairs  

The Investigational Medicinal Product Dossier (IMPD) is a key regulatory document required for clinical trial approval in the European Union. It provides comprehensive information on the quality, manufacturing, and safety of an investigational drug. The IMPD is essential for ensuring that clinical trials are conducted with high standards of safety and efficacy. In this video, we’ll break down the IMPD process, its components, and how it facilitates clinical research.

What You’ll Learn:

• What an IMPD is and its significance in clinical trial approval.
• Key components of an IMPD submission, including quality, preclinical, and clinical data.
• The regulatory review process and timelines for IMPD approval in the EU.
• Differences between IMPD, IND (Investigational New Drug), and CTA (Clinical Trial Application).
• How the IMPD ensures compliance with Good Manufacturing Practices (GMP) and patient safety standards.

This video is a must-watch for pharmacy students, regulatory professionals, and anyone interested in clinical trials and drug development. Understanding the IMPD process is crucial for bringing innovative medicines to patients while ensuring safety and regulatory compliance.

If you find this video informative, don’t forget to like, comment, and share it with your peers to spread awareness about the IMPD approval process!

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