Medical Writing Fundamentals: How to Write Regulatory Documents

Course Description

Medical writing has its own standard practices and idiosyncrasies. Knowing what to write, how to format, and how to navigate corporate processes can require a big learning curve. This web seminar will give learners an overview of writing practices, formatting, working with tables/figures, and communicating effectively. Practical applications of these skills will be described as they apply to writing all types of documents for submission to global regulatory authorities, including protocols, clinical study reports, investigator’s brochures, data management plans, statistical analysis plans, documents for modules in the Common Technical Document (CTD) format, and briefing books. Real-life examples of strategies for generating a great document by understanding the what and why of the different documents will also be presented.

Learning Objectives

• Review basic medical writing skills, including correct abbreviation practices, consistent captioning, and table generation
• Utilize styles and templates
• Describe style guides and their importance
• Describe the communication process needed for document review and completion
• Conduct a literature search
• Apply these skills to all regulatory documents

Who Should Attend

• New Medical Writers
• Clinical Research Professionals (i.e., CRAs, Data Managers)
• Statisticians
• Study Coordinators
• Document Signatories (i.e., Chief Medical Officers, Clinical Pharmacologists)
• Personnel who review regulatory documents or are involved with investigator-sponsored studies

Instructor

Joy Frestedt, Ph.D., C.P.I., R.A.C., F.R.A.C.P.

Click here for complete trainer biographies

Registration Fees

$735

Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.

Note: Due to COVID-19, we understand that most teams cannot currently dial-in together. As such, we are able to offer additional logins at a highly reduced rate. Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 to register with your additional participants requiring login credentials. Or email Customer Service at: customer.service@barnettinternational.com

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 1.5 hours (0.15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-23-071-L99-P. Released: 8/23. 

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.