Clinical Trials and Regulatory Writing Primer
FPM-40672
This course introduces the components of effective clinical trial design, and the basic phases, and purposes of pharmacological and clinical development. Gain foundational knowledge of the overall clinical development process and understand and adequately use clinical trial terminology that is used in regulatory writing. Topics include trial designs by stage, types of trial designs, ethical considerations, study procedures, endpoints, data analyses and statistical considerations.
There are no prerequisites for this course and it is open to those seeking a individualized learning expereince. Serves as a required course for students pursuing the Medical Writing Regulatory Capstone Track. Equivalent coursework or knowledge must be demonstrated if the student does not have pharmaceutical industry background. By the end of this course, you will be able to:
Identify the basic terminology related to clinical trials and the pharmaceutical industry
Discuss the clinical research process and clinical trial designs
Build foundational skills for advanced regulatory writing projects
Course Information
Course sessions
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This course is entirely web-based and to be completed asynchronously between the published course start and end dates. Synchronous attendance is NOT required.
You will have access to your online course on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.
Textbooks:
All course materials are included unless otherwise stated.
Policies:
- No refunds after: 6/30/2025
Schedule:
Instructor:
Yeshi Mikyas
Dr. Yeshi Mikyas has 23 years experience in different areas of clinical trial conduct (academic and industry setting), with 16 years specifically in Medical Writing. She earned her BSc in Biology and PhD in Molecular Biology and Medical Pharmacology from UCLA. Her Medical Writing experience includes the preparation of regulatory and safety documents, and journal articles, reviews, abstracts, and presentations. Yeshi is currently the Senior Director, Medical Writing at Pfizer overseeing the preparation of regulatory documents for submission and disclosure. She has been involved with the UCSD Extension Medical Writing program since 2015, and has led the Regulatory Writing Capstone since its first offering in 2017. She is passionate about empowering and encouraging medical writers to be strong effective partners within their teams.
