Capstone: Regulatory Writing
FPM-40628
Regulatory Writing is as much about knowing the regulations and guidance that govern regulatory submissions as it is about the building the intelligence, knowledge, relationships, and know-how in becoming an effective partner at the table. This course is designed to help you
· Gain a better knowledge of the regulations and guidance documents that govern certain regulatory documents and processes in the US and EU.
· Gain hands on experience in thinking through and writing the CSR, a key regulatory document, and
· Understand your role, responsibilities, critical behaviors, and practical work practices that makes you a better Regulatory Writer
*To be eligible to take this course you must have completed all of the other courses in the Medical Writing program with a B-/80% or higher.
Course Information
Course sessions
Section ID:
Class type:
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: 10/7/2024
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.
