Course 2: Introduction to Regulation in Research
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Full course description
What you'll learn:
The course provides an overview of the FDA, its structure, authority and regulations.
What you'll do:
This course provides an overview of the history, framework and FDA regulations that govern the conduct of clinical research in the US. The course provides an overview of the FDA, its structure, authority and regulations. The course includes a review of regulations related to the conduct of clinical trials, protection of research subjects, good clinical practices, roles and responsibilities of study staff, sponsor, IRBs, and ends with a look at global regulatory authorities.
Who this course is designed for:
What you'll receive:
A certificate of completion
Meet the instructor
JoAnn Pfeiffer, DrSC, MS, RAC, CCRA - Senior Director and Clinical Professor
Dr. Pfeiffer is the Senior Director and a Clinical Professor for the Masters’ Degree programs in Clinical Research Management (CRM) and Regulatory Science (RS) at Arizona State University (ASU). She has been with ASU since 2014, starting as a faculty associate, moving to the position of Associate Director in 2015 and Program Director in 2016 Program Director and is currently the Senior Director. During her tenure she has had the opportunity to be involved in the growth, success and many wonderful opportunities provided in academia. She was instrumental in adding the Regulatory Science Masters online program, the Regulatory Science Masters hybrid program, and recently a certificate and concentration in Food Safety in the Regulatory Science Program. She has watched the program grow and graduates become leaders in the medical products field. She coordinated the application for program accreditation for the CRM programs in 2018 and ASU became the first accredited program in the US.