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. 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.

Who Should Attend

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.

Zeinab Schwen

Zeinab Schwen

Specialties: Management

Zeinab Schwen has over 30 years of experience in the Pharmaceutical and Medical Device industry and is presently the President of Strategic Regulatory Consulting.

In her present capacity she has provided product development, regulatory consulting, and medical communications services to firms such as Eli Lilly, Procter & Gamble, ICOS Pharmaceuticals, Kendle Research (now INC), Ethicon Endosurgery, Johnson & Johnson, Alexion and many CROs. Prior to founding her present company, she worked for Marion Merrill Dow and was a Faculty Member at the University of Cincinnati. Ms. Schwen is also a past president of the American Medical Writers Association's (AMWA) Ohio Chapter during which she organized and taught numerous regional workshops for medical writers.

Courses:

• Technical Writing for Pharmaceutical, Medical Device and Biotech Industries

Publications:

Ms. Schwen has written over 100 articles for lead authors in numerous peer reviewed medical journals and has lectured on many professional topics such as: clinical trial design, developing medical writing guidelines and SOPs, organizing biomedical papers, authorship ethics, how to market your medical writing business, how to write protocols, patient narratives, final clinical reports, and more.