Volume 28, Issue 3 - Trends in medical writing
Regulatory Matters
Authors: Jennifer Morris, Joan Affleck
Abstract
Changes in the regulatory landscape and changes in our professional environment make this an exciting time to be part of the regulatory medical writing community. It is a time when new opportunities are presenting and when, like never before, the medical writing community has chosen to come together to conscientiously shape our professional landscape. As this happens, we recognise and value well-established approaches, reinforce innovations in practice, and secure the future for our profession.
Download the full article
References
- Van Arnum P. Pharma and Brexit: What happens next? DCAT Value Chain Insights. 2019 May 14 [cited 2019 Jun 25]. Available from: https://www.dcatvci.org/5960- pharma-and-brexit-what-happens-next.
- US Food and Drug Administration. Real- Time Oncology Review Pilot Program. 2019 [cited 2019 July 1]. Available from: https://www.fda.gov/about-fda/oncologycenter- excellence/real-time-oncologyreview- pilot-program.v
- Clemow DB, Wagner B, Marshallsay C, et al. Medical writing competency model - section 1: functions, tasks, and activities. Ther Innov Regul Sci. 2018;52(1):70–7.
- Clemow DB, Wagner B, Marshallsay C, et al. Medical writing competency model - section 2: knowledge, skills, abilities, and behaviors. Ther Innov Regul Sci. 2018;52(1):78–88.
- American Medical Writers Association. Certification. 2019 [cited 2019 Jun 20]. Available from: https://www.amwa.org/page/MWC.
Visit the EMWA website
Search
Articles
Member Login
Links
Editoral Board
Editor-in-Chief
Co-Editors
Managing Editor
Victoria White
Deputy Managing Editor
Alicia Waltman
Associate Editors
Section Editors
Biotechnology
Digital Communication
EMWA News
Getting Your Foot in the Door
Good Writing Practice
Alison McIntosh / Stephen Gilliver
In the Bookstores
Manuscript Writing
Medical Communications/Writing for Patients
Medical Devices
My First Medical Writing
News from the EMA
Out on Our Own
Pharmacovigilance
Regulatory Matters
Regulatory Public Disclosure
Teaching Medical Writing
The Crofter: Sustainable Communications
Veterinary Writing
Editors Emeritus
Lay out Designer
Chris Monk