RAPS is looking for authors for the June RF Quarterly, which publishes original, research-based content on trends and emerging issues in the global regulatory landscape. The lead editor for the issue will be Daniel G. Mannix, PhD, chair of the RAPS Editorial Advisory Board.
The articles will focus on Regulatory Writing and its importance in ensuring effective communication, quality and compliance, successful submissions, and timely delivery of safe, life-altering/saving medical products. Article topics might include, but need not be limited to, the following:
- Good documentation practices
- Guidance documents for regulatory writing
- Challenges and obstacles in regulatory writing
- The regulatory writing process/workflow
- Internal review and approval processes (presubmission)
- Writing in specialty areas: Pediatric Investigational Plan, combination products; biosimilars; vaccines and biologics; and rare diseases and orphan designations
- Writing in the clinical study setting: Protocols, statistical/data analysis plans, informed consent, clinical study reports, and accessible summaries
- AI in medical writing
Read the Guidelines for Authors to learn more about RF Quarterly and how to submit an article. For more information, email rmatthews@raps.org
The due date for the article would be 10 am US EST, 21 April 2025.
Please note that AI-generated content will not be considered for publication.
Qualifications:
· Regulatory professionals with expertise or a focus in the topic area
· 5 years + industry experience
Number of openings:
10
Recertification Credits:
5
Staff Liaison
Renée Mathews, Senior Editor, Regulatory Focus