Regulatory Affairs and Quality Assurance - Pharmaceutical Inspections and Audits (Based on ICH-Q10). Peivand Pirouzi, Ph.D.

In this video, Professor Peivand Pirouzi provides a detailed overview of pharmaceutical inspections and audits with a focus on Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Pharmacovigilance. This presentation covers the ICHE2A-E2F guidelines, which are crucial for ensuring the integrity, safety, and compliance of pharmaceutical products throughout their lifecycle.

Key topics include:

The importance of GMP in maintaining the quality and consistency of pharmaceutical products.
An introduction to GCP standards and how they are applied to clinical trials to ensure ethical and scientifically valid research.
The role of Pharmacovigilance in monitoring the safety of pharmaceutical products post-market.
A breakdown of the ICHE2A-E2F guidelines, focusing on the responsibilities of manufacturers, sponsors, and regulators.
Best practices for preparing for and conducting pharmaceutical inspections and audits, ensuring regulatory compliance at every stage.

This video is designed for pharmaceutical professionals, auditors, clinical researchers, and anyone interested in understanding the rigorous standards governing the development, approval, and post-market surveillance of pharmaceutical products.