Medical Writing Trends in medical writing Regulatory Matters

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.

References

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  2. 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
  3. 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.
  4. 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.
  5. American Medical Writers Association. Certification. 2019 [cited 2019 Jun 20]. Available from: https://www.amwa.org/page/MWC.

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Articles

Introduction
President's Message
EMWA News
Omics in silico and other trends in biomedical research: Impact on how and what we write
Catching the wave of lifestyle medicine
Artificial intelligence – will we be replaced by robots?
Now more than ever, scientists must speak up for science
When less is more: Medical writers as guardians of curated content
Predatory publishing – what medical communicators need to know
AMWA – EMWA – ISMPP Joint Position Statement on Predatory Publishing
How to combat medical misinformation with a sound content strategy
Subcontracting: Not for the faint of heart
Lay summaries and writing for patients: Where are we now and where are we going?
Clinical trial disclosure: Perspective from a medical writer for a contract research organisation
The 360° approach to authoring risk management plans
Trends in regulatory writing: A brief overview for aspiring medical writers
The medical writing landscape in China
News from the EMA
Regulatory Matters
Medical Communications and Writing for Patients
In the Bookstores
Getting Your Foot in the Door
Veterinary Medical Writing
Medical Devices
My First Medical Writing
Journal Watch
Good Writing Practice
Regulatory Public Disclosure
Out on Our Own

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