Volume 28, Issue 3 - Trends in medical writing
Regulatory Matters
Authors: Jennifer Clemens, 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.
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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.
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