Understanding, navigating, and complying with the United States Food & Drug Administration (FDA)'s regulations is vital to translating medical discoveries from "bench to bedside". In this course, we will explore why regulations are important for public health, how to navigate through the FDA regulations to market a biologic or pharmaceutical, and practice developing a regulatory strategy.
At the end of this course, we will understand the drug development process and learn the key regulatory steps toward FDA approval. With this knowledge, we will also develop our ability to conduct regulatory intelligence and develop a regulatory strategic plan.
Scientists, physicians, entrepreneurs, public health professionals, industry analysts, consultants, and biomedical students interested in the biotechnology and pharmaceutical industry may find this course valuable.
A brief lecture introducing the instructor and his motivation behind creating this course.
This lecture a student will gain a high-level overview of the drug development process, the trend in acute to chronic diseases, and the different industry stakeholders.
We will learn the history and organizational structure of the US Food and Drug Administration (FDA) relevant to drug development.
In this lecture, we will cover the role of a Regulatory Affairs Professional in drug development, their responsibilities, and their backgrounds.
In this course, we will shepherd a fictional drug through the drug development process. This lecture will introduce us to this drug and our team.
An important key in developing a strategy is to be informed through gathering data and producing actionable intelligence. This lecture will introduce us to the common primary and secondary sources of information used to produce a regulatory strategy.
This lecture will review the nonclinical information needed to file an Investigational New Drug (IND) to the FDA.
To develop and commercialize a drug, a team needs to consider the manufacturing components to assure that the drug is of high quality.
In this lecture, we will review the necessary information needed to file an original IND to the FDA.
This lecture will summarize the key points made in Section 2 toward preparing an IND submission to the FDA.
After IND submission, what happens next? In this lecture, we will review the key interactions between the FDA and applicant immediately after IND submission.
Regulatory strategy begins before IND filing yet managing and adapting this strategy continues during clinical development. In this lecture, we will learn more about creating a regulatory strategy before and during clinical development.
This lecture will cover the basic IND management activities of a Regulatory Affairs professional.
Clinical development is broken down into three distinct phases. This lecture we will review the Phase 1 aspects.
Clinical development is broken down into three distinct phases. This lecture we will review the Phase 2 aspects and key regulatory milestones.
Clinical development is broken down into three distinct phases. This lecture we will review the Phase 3 aspects.
This summary lecture will highlight the key points made in Section 3.
After clinical development has completed, preparing the NDA or BLA requires a cross-functional team to provide all the information in a structured method. We will learn the structure and content of the NDA.
Once the NDA or BLA is submitted to the FDA, there is a lengthy review process involving both the applicant and FDA. We will learn what this process entails.
After a drug or biologic is FDA approved, what happens next? In this lecture we will understand the post-marketing activities.
We will wrap-up this course with the instructor's final thoughts and an optional project.
My overarching mission is to empower others to improve health through individual- and population-based solutions.
I have a broad background in health from exercise, nutrition, rehabilitation, medicine, and public health. With experience in clinical research and regulatory affairs, I hope to provide you my insight into developing novel medical products. I also enjoys providing personal training, nutrition advice, and coaching to reduce the risk of chronic diseases and to improve athletic performance.
I graduated with both a MS in Exercise Science and BS in Exercise Biology from the University of California, Davis. I also received the US Regulatory Affairs Certificate (RAC) from the Regulatory Affairs Professional Society (RAPS).
Looking forward to seeing you in class!