Industries: Pharma / BiotechMedical Device

Introduction to Effective Medical Writing

Course Director: Zeinab Schwen

Course Fee: $2150.00 Regular Registration / $1950.00 Early Bird (30 Days in Advance)

  Accreditation: ***RAPS Approved Course*** 

PharmaTrain Recognized Course    

Course Description - Course runs 9:00 to 5:00 both days (Breakfast and Lunch Included)

Medical writing is both a science and an art. The art of medical writing is to comprehend and present scientific information clearly to suit the specific target audience's level of understanding including patients, the general public, physicians and/or regulatory agencies. Often it is not poor science that kills a scientific paper; rather, it is the lack of clarity and continuity. Poor writing can be very costly to companies and frequently slows the review process of regulatory submissions.

In this 2-day course, you will learn about the different types of medical writing and how to write effectively. We will examine various types of writing including abstracts, regulatory documents, and patient education materials. We will also consider ethical issues that face medical writers. You will gain insight into the design of effective documents and what goes into putting together a compelling manuscript. This medical writing course will also teach you how to keep reports free of medical jargon and common grammatical errors, while ensuring the scientific integrity of your work.

Who Should Attend

This medical writing course is valuable to those who write or review documentation in support of clinical trials and regulatory submissions. It will also benefit anyone who prepares or reviews articles or abstracts about therapeutic products for publication. The course is particularly helpful for those new to these disciplines who wish to understand the scope of medical writing. Typical attendees include medical writers, reviewers of medical documents, clinical research managers and associates, regulatory affairs professionals, project physicians and medical monitors.

Course Agenda

First Day

The Scope and Role of the Medical Writer

  • Introductions and course agenda
  • The scope of medical writing
  • The cost of “Bad” writing
  • The writer’s role
  • Assessing your target audience

Basics of Good Medical Writing

  • Qualities of an effective medical writer
  • Objectivity, accuracy and tone
  • Tools of the trade: references, style guides, and resources
  • Grammar and punctuation
  • Abbreviations and jargon
  • Presenting statistical data
  • Ethical considerations

Achieving Flow and Cohesiveness

  • Document format and design
  • Writing effective paragraphs and transitions
  • Using effective data displays and visual elements
  • Final document quality: the importance of editing and proofreading
  • Overcoming writer’s block and finding time to write

Second Day

Overview of the Regulatory, Marketing, and Drug Promotion Processes

  • How the regulations drive medical writing (FDA & ICH)
  • The Common Technical Document (CTD)
  • IND/IDE Submissions
  • Clinical protocols, amendments, and study reports
  • NDA/BLA/PMA and 510k regulatory submissions
  • Manuscripts for publication in scientific journals

The Clinical Study Report

  • Sections of a clinical study report
  • Templates and boilerplate text
  • Purpose of each section
  • Tips on writing each section of the clinical study report

Writing for Publication

  • Publishers’ requirements for manuscripts
  • Standard manuscript elements: abstract, introduction, materials and methods, results, and discussion
  • Preparation, references, submission, acceptance, revision, publication

Managing the Review Process

  • Charting the process flow
  • Establishing metrics for managing regulatory submissions
  • Putting a disclosure process in place
  • Effective review practices
  • Managing disparate comments from reviewers
  • Working with thought leaders and reaching concurrence

Learning Objectives

Upon completion of this course you will understand:

  • What medical writing encompasses
  • How to assess your target audience and choose the appropriate style and tone for the reader
  • How to write different types of documents
  • How to write documents that meet the company's goals and objectives
  • How to use sentence and paragraph structure to give your writing clarity and impact
  • How to create effective data displays (tables, charts, diagrams)
  • The role of the writer in producing, proofing and issuing documents
  • The best ways to manage the review process and meet timelines
  • The ethical issues that face medical writers


"CfPIE organizes a great course! The Course Director provides excellent material. She gave great examples, and supported them during workshop activities. She also invites questions for future follow-up. It has been a pleasure to return to CfPIE for a new course topic and have a familiar instructor that was enjoyable the first time. I'm looking forward to my next course and eventually completing my certification." Karin B., Technical Writer III, Gen-Probe
"The course was very interesting and the trainer excellent!" Sonja Project Manager Pharmacology/Toxicology, medac GmnH
"Very good background for this subject. Real world knowledge. Fun and engaging. Able to relate the information to our company. Very good at handling questions." Steven B., Chief Medical Office, Proteon Therapeutics
"Very informative course. Great binder of materials. Zeinab was very knowledgeable and a great presenter. Thank you!" Missy M., Biostatistician, Proteon Therapeutics
"This was an engaging workshop, extremely useful for our small biotech company. Zeinab made what could have been a dry workshop, very interesting, kept everyone engaged and interested with hands on exercises and good discussions of questions and points of interest. Thank you!" Laura B., Regulatory Affairs Consultant, Proteon Therapeutics
"An excellent orientation for new writers as well as detailed, comprehensive strategies for successful submissions that will be useful for experienced medical writers." Diahann H., Consulting Medical Writer, Abbott
"Very useful course! The review of basic language and grammar concepts such as active/passive voice, parallel form, use of punctuation, etc. was very helpful as these concepts have not been reviewed since middle school. Appropriate pace throughout the course and also great discussion among attendees. The Course Director is a great teacher and really engaged students. Thank you!." Anupma R. – Post Doctoral Fellow – Cubist Pharmaceuticals
"The course went above and beyond my expectations. It was extremely informative and the instructor was knowledgeable and dynamic." Marie V., Project Coordinator, SuperGen
"As a Document Specialist for Novartis, who reviews protocols and study reports to ensure that they meet all FDA and internal guidelines, I found this course to be extremely helpful and informative. The course afforded me a better understanding of the details of writing a Study Report. I will inform my management of how important this course will be to help all new hires, as well as, seasoned scientists who need to become more effective writers." Theresa M., Document Specialist, Novartis
"Best presentation on Medical Writing ever!" Diane B., Coley Pharmaceuticals
"I enjoyed the Course Director's presentation and communication. I gained a wealth of knowledge . I know have a better understanding of the writing process." Joanne A., Sr. Med Affairs Coord, Bayer Healthcare Pharmaceuticals
"Content – Perfect balance; Director – They don't get any better; Group make-up – Very good for input, contribution, and contacts." Colette L., MD, FRCPC, CRC Partners STD
"This was an excellent course for me in my current work in protocol review and leading medical imaging charter development. The group sessions were helpful to gain an alternative thinking and writing approach. I will definitely attend future CfPIE courses and encourage my leadership to send my colleagues." De Jane H., Director, Medical Imaging, Amgen
"The Course Director provided very useful information and outside references, and offered continued assistance and resources after the conclusion of class. Great instructor, great class." Darlene N., Sr. Process Engineer, Covidien
"The Course Director was wonderful! Her teaching style was extremely friendly and informative. It was refreshing to see genetics examples of medical writing in our class, which is my specialization. I will return to take the other medical writing courses for the certification program. Thanks again to the Course Director and your staff who were pleasant and provided excellent service." Valerie K., Clinical Documentation Specialist II, Alexion Pharmaceuticals

Frequently Asked Questions

What documentation does a company need to start a clinical trial in the United States?

A clinical trial can only occur if extensive preclinical testing is adequate to show that a product is safe for testing in humans. The company must have controlled records of all product development activities leading up to testing in humans. A submission to the agency then draws upon the nonclinical documentation and summarizes it as proof of a viable test candidate. An Investigational New Drug application (IND) for drugs and biologics or an Investigation Device Exemption (IDE) for class III devices typically includes applicable forms, such as Form 3674 (Certification of Compliance); an introductory statement and a general investigational plan overview; the actual protocol; an Investigator Brochure (IB), which provides information for the investigators; chemistry, manufacturing, and controls and/or design controls; and pivotal nonclinical studies. The company must have adequate SOPs in place to cover clinical activities, such as PI and site selection, data collection, trial monitoring, and trial document management. Electronic record keeping systems for trials also require validation and the resulting documentation.

Is there a requirement for publishing in scholarly journals as we complete clinical trials?

Transparency is the reality today, and the expectation is that companies will publish results of clinical trials. The International Conference on Harmonisation (ICH) E6 Good Clinical Practice specifically calls for a publication plan as part of clinical development. Further, FDA mandates trial registration (public law 110-85, Section 810), and most journals also require registry of a phase 2, 3, or 4 clinical study on a publicly accessible database, such as or These registrations link to related publications.

How can we determine authorship of the articles we publish?

The International Committee of Medical Journal Editors (ICMJE) defines authorship. "An author must take responsibility for at least one component of the work, should be able to identify who is responsible for each other component, and should ideally be confident in their co-authors' ability and integrity…Some journals now request and publish information about the contributions of each person named as having participated in a submitted study, at least for original research" ( Thus, conducting research and determining results are a basis for authorship. Other people, such as medical writers, may assist in compiling and organizing information and preparing and editing manuscripts. Such contributors deserve acknowledgement.

RAPS | Regulatory Affairs Professionals Society CfPIE is a Regulatory Affairs Professional Society (RAPS) RA Professional Development provider.

CfPIE is committed to enhancing the ongoing professional development of regulatory affairs professionals and others through appropriate regulatory affairs learning activities and programs.  CfPIE has agreed to follow RAPS-established operational and educational criteria.  Click here for the list of courses reviewed and approved by RAPS.