EU-EMA Good Clinical Practice (GCP) and Regulatory Framework

This material is a compilation principles of Good Clinical Practice (GCP) in clinical trials, as presented by the European Medicines Agency, offering a glimpse of how researchers navigated unprecedented challenges like the COVID-19 pandemic to ensure patient safety and data integrity. The case provides an in-depth look at the principles of Good Clinical Practice (GCP), an international standard for ethical and scientific quality in clinical trials involving human subjects. It highlights the role of key stakeholders, such as pharmaceutical companies, clinical research organizations, and regulatory authorities, in ensuring trial participants' safety and the reliability of trial data. Additionally, it addresses specific challenges posed by the COVID-19 pandemic, such as adapting trial protocols and maintaining data integrity during extraordinary circumstances. We underscore the importance of ethical standards and collaboration in global clinical research.