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Session 3 Track 2: Exploring the Interplay of Regulatory and Publication Writing
Session Chair(s)
Lisa DeTora, PhD, MS
Associate Professor, Director of STEM Writing
Hofstra University, United States
Medical writers work in many different settings, including regulatory documentation, publications, and medical communication. While each of these areas has guidelines and may be impacted by regulations, understanding the relationships between these areas may be difficult, limiting opportunities for effective teambuilding or career progression. In some cases, an awareness of medical writing requirements in some areas, such as publications, might also help improve document development in other settings, such as protocols or data analysis plans. The connection between regulatory guiedlines like ICH E3, ICH E6 and publication recommendations like the CONSORT/SPIRIT guideline will be discussed, as will experiences of writers who work in various areas.
Learning Objective : At the conclusion of this session, participants should be able to:- Describe the range of medical writing roles
- Identify guidelines for publications and their relationship to common regulatory guidelines
- Discuss opportunities for interdisciplinary cooperation and learning
Speaker(s)
Panelists
Jenny Boyar, PhD
Abbvie, United States
Principal Medical Writer
Panelists
Jennie G Jacobson, PhD
Jacobson Medical Writing, Inc., United States
President