Regulatory guidance: Introduction
We are delighted that you have chosen to enhance your educational journey in immuno-safety science by enrolling in this module. The "Regulatory Guidance: Introduction" lecture is one of a series of 18 lectures included in the Introduction to Immuno-Safety Science module and is led by Dr. David McMillan at the United States Food and Drug Administration. Please review the learning objectives below for more information on what you will learn in this lecture.
If you are new to HESI and would like to learn more about our organization, please take a moment to visit our website at https://hesiglobal.org.
This course is intended for the science professional or graduate student looking to learn the fundamental science and key considerations that are examined in immune safety assessment. Advanced topics and courses that take a deeper dive into specific scientific areas will be offered and recommended for the more experienced scientist with a firm grasp of the information highlighted in the introduction module.
- Provide a brief history and timeline of guidance documents
- Describe the importance and application of various guidance documents (broad overview) in drug development
David McMillan, PhD
United States Food and Drug Administration
- 1.00 Participation