REGULATORY FOCUS - GUIDE TO ARTICLE TYPES

 

Perspectives

These are articles on controversial topics or recent developments in the industry and can cover strategic industry issues, technical developments, innovative solutions or regulatory trends. They should stimulate debate, present new models or hypotheses (along with suggestions for future improvements) or speculate on the meaning or interpretation of some new data. Articles can outline recent advances in a field and expand on their application to the regulatory profession or professional. Perspectives are reviewed by subject matter experts from the Editorial Advisory Committee.
 
Length:
2000 words minimum
+ 20 references max
2–3 figures or tables
100-word summary
2–3 sentence description
 

Technical Articles

These are practical application articles defining and demonstrating, through the use of examples, global best practices and regulatory issues associated with healthcare products and the regulatory profession. Recurring topics include advertising, promotion and labeling; regulatory business acumen; ethics; government, regulatory bodies, law and legislation; quality and compliance; education and professional development, and regulatory science and leading-edge technology. Technical articles are reviewed by subject matter experts from the Editorial Advisory Committee.
 
Length:
3000 words minimum
30 references max
3–4 figures or tables
100-word summary
2–3 sentence description
 

Case Studies

These are articles that review a real-life approach, example or solution to an industry problem, describing in detail the approach and the outcome. Authors should provide a critical analysis of the method, process or technology, discussing any difficulties encountered during the project and providing a balanced and supported view of the pros and cons of this approach versus other approaches. Case studies are reviewed by subject matter experts from the Editorial Advisory Committee.
 
Length:
4000 words minimum
40 references max
4–6 figures or tables
100-word summary
2–3 sentence description
 

Research Articles

These are standard format research articles with an Introduction, Methods, Results and Discussion sections. They should describe in detail new and innovative methods and techniques used by regulatory professionals serving all aspects of the healthcare and related products industry, including pharmaceuticals, medical devices, biologics, biotechnology, in vitro diagnostic devices, nutritional products, cosmetics, veterinary products and related fields. Emphasis should be given to sound research methods and results. All conclusions must be supported by adequate evidence. Scientific rigor and reproducible results are required. Research articles are reviewed by subject matter experts from the Editorial Advisory Committee.
 
Length:
5000 words minimum
50 references max
6–8 figures or tables
100-word summary
2–3 sentence description
 
For more information, contact:
Gloria Hall
Senior Editor
Regulatory Focus, Feature Articles
Regulatory Affairs Professionals Society
5635 Fishers Lane, Ste. 550
Rockville, MD 20852
813-748-1415
email: ghall@raps.org