Pharma / BiotechMedical Device
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. You will also learn how to keep your writing free of medical jargon and common grammatical errors, while ensuring the scientific integrity of your work.
This 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.
The Scope and Role of the Medical Writer
Basics of Good Medical Writing
Achieving Flow and Cohesiveness
Overview of the Regulatory, Marketing, and Drug Promotion Processes
The Clinical Study Report
Writing for Publication
Managing the Review Process
Upon completion of this course you will understand:
"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
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.
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 clinicaltrials.gov or Eudra.Pharm.eu. These registrations link to related publications.
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" (ICMJE.org). 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.
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The Center for Professional Innovation and Education (CfPIE) provides technical training for Pharmaceutical, Biotech, Medical Device and Skin/Cosmetics professionals. CfPIE offers more than 350 class sessions annually across 80 course titles in multiple formats, such as classroom, on-site and certification programs.
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