Regulatory Writing

January 16, 2025 to April 19, 2025
Gain in-demand medical writing skills that will help elevate your career in healthcare or medical communications with a certificate in regulatory writing.
 
The University of Chicago’s non-credit certificate in Medical Writing and Editing uses the AMA Manual of Style as the foundation for mastering the fundamentals and best practices of medical writing, editing, and communication.
 
The University of Chicago’s certificate program in Regulatory Writing gives you the training to write submissions to the FDA and other regulatory bodies. This two-course program covers everything from the basics of editing documents like informed consent forms to collaborating on creating biomedical regulatory packets to navigating the writing, submission, and auditing processes. This program has a synchronous component and can be completed within a minimum of three months.
 
Learn more at our website!

Target Audience

Designed for professionals with backgrounds in the healthcare industry or technical writing interested in embarking upon or shifting into a career in regulatory writing.

Learning Objectives

After this activity, participants will be able to:

  • Identify key components of a regulatory submission package, including essential documentation for FDA and global approval processes;
  • Analyze relevant regulatory guidelines and industry standards to ensure compliance in biomedical regulatory writing;
  • Apply the AMA Manual of Style and other regulatory standards to produce accurate, clear, and concise regulatory documents;
  • Revise regulatory documents based on peer review feedback, ensuring alignment with submission requirements and improving clarity and precision;
  • Evaluate the effectiveness of regulatory writing in meeting audience-specific needs, including the regulatory body’s standards and expectations;
  • Synthesize complex regulatory information to create comprehensive, well-organized submission materials for biomedical products;
  • Collaborate with cross-functional teams to produce regulatory documents that meet regulatory requirements and enhance submission quality;
  • Interpret biostatistical data and other scientific findings accurately for inclusion in regulatory submissions, ensuring compliance with ethical and publication standards.
Additional information
ACGME/ABMS Core Competencies: 
Professionalism
For more information, please contact:
CME Coordinator Contact Name: 
Karine Bravais
CME Coordinator Contact Email: 
kbravais@uchicago.edu
CME Coordinator Contact Phone: 
773.795.8273

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Summary
Available credit: 
  • 112.00 AMA PRA Category 1 Credit™
  • 112.00 Participation
Event starts: 
01/16/2025 - 6:00pm
Event ends: 
04/19/2025 - 11:00am
Activity opens: 
04/19/2025
Activity expires: 
07/19/2025
Add to calendar: 
Virtual
Chicago, IL
United States
WANT TO KNOW MORE?
Visit the Regulatory Writing program website!
 
ACCESSIBILITY The University of Chicago is committed to providing equal access appropriate to need and circumstances and complies fully with legal requirements of the Americans with Disabilities Act. If you are in need of special accommodation, please contact our office at 773.795.8273 or via email at kbravais@uchicago.edu.
 
 The University of Chicago reserves the right to cancel or postpone this activity due to unforeseen circumstances. In the unlikely event this activity must be cancelled or postponed, the registration fee will be refunded; however, The University of Chicago is not responsible for any related costs, charges, or expenses to participants, including fees assessed by airline/travel/lodging agencies.
UNIVERSITY OF CHICAGO PLANNING COMMITTEE
  Karine Bravais, MA, MS
  Director of Professional Development Programs
  University of Chicago Professional Education (UCPE)
 
 

 
  Mary Morley Cohen, PhD
  Managing Director
  University of Chicago Professional Education (UCPE)
 
 

 
  Yacob Abdi, MS
  Program Manager
  Professional Development Programs
 
 
 

Learn more about the course instructors!

Disclosure Declarations
As a provider accredited by the ACCME, The University of Chicago Pritzker School of Medicine asks everyone in a position to control the content of an education activity to disclose all financial relationships with any ineligible companies. This includes any entity whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients. Financial relationships are relevant if a financial relationship, in any amount, exists between the person in control of content and an ineligible company during the past 24 months, and the content of the education is related to the products of an ineligible company with whom the person has a financial relationship. Mechanisms are in place to identify and mitigate any relevant financial relationships prior to the start of the activity.

Additionally, The University of Chicago Pritzker School of Medicine requires Authors to identify investigational products or off-label uses of products regulated by the US Food and Drug Administration at first mention and where appropriate in the content.
Physician Credit
The University of Chicago Pritzker School of Medicine is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.
 
The University of Chicago Pritzker School of Medicine designates this live activity for a maximum of 112 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Other Participant Credit
Other participants will receive a Certificate of Participation. For information on the applicability and acceptance of Certificates of Participation for educational activities certified for AMA PRA Category 1 Credit™ from organizations accredited by the ACCME, please consult your professional licensing board.
 
Please Note: The credit claiming process will close three months after the activity ends. Requests to claim credit after three months will be subject to additional fees.
Registration: Learn more about this activity by clicking below!

 
 
Claiming Credit: Enter the access code to unlock the credit-claiming process.
Please Note: The credit claiming process will close three months after the activity ends. Requests to claim credit after three months will be subject to additional fees.
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