Regulatory Focus provides timely, in-depth feature articles on current and far-reaching global regulatory issues. Departments cover topics of interest to regulatory professionals, such as ethics, scientific and technological innovations, legal and governmental affairs, professional development strategies, and quality and compliance regulations.
Regulatory Focus readers comprise the entire spectrum of healthcare regulatory professionals in the areas of drugs, medical devices, biologics, biotechnology, in vitro diagnostic devices and related fields.
Types of Articles: Regulatory Focus accepts unsolicited articles, but does not guarantee publication of all submissions. It is preferred that potential authors first submit a two- to three-sentence synopsis of article topic.
- Features: fact-based, in-depth articles
- Departments: legal, regulatory, professional development, technology, policy, education, quality or ethics issues (see below)
- Perspective: author viewpoint on any regulatory, professional development or RAPS-related topic
Review: All articles published in Regulatory Focus are reviewed by members of the Board of Editors.
Payment: RAPS does not pay any financial remuneration to authors.
Recertification: RACs earn five recertification points for each article published.
Reprints: After the article is published, it may be posted on the company website. Contact the editor for more information.
Contact
Editor
Regulatory Focus
Regulatory Affairs Professionals Society
5635 Fishers Lane, Ste. 550
Rockville, MD 20852
email: editor@raps.org
Departments
It's the Law. Legal topics, legislation and government initiatives that impact regulatory professionals
Science & Technology. Advances in science and information technology used by regulatory professionals
Essentials. Fundamental information and issues related to general career and professional development
The Regulatory Manager. Organizational and management roles, strategic planning, leadership styles, and negotiation and cultural perspectives
Quality & Compliance. Quality regulation issues—GMPs, ISO, GCPs, GLPs, CE marking, etc.—and the global/national compliance environment
Perspective. Short, conversational column on any regulatory, professional development or societal topic
Books. Reviews of books pertinent to the regulatory profession.
Article Preparation
- Manuscripts must be prepared in Word for Windows.
- Manuscripts must be submitted via email.
- As appropriate, sidebars and/or call-outs should be included.
- Authors are encouraged to provide graphics with manuscripts. A maximum of five figures (photographs, illustrations, charts, tables, etc.) may be submitted per article.
- Only figures that meet the following criteria will be accepted:
- 300 dpi (high-resolution suitable for printing at actual size or larger). Line art, usually tagged as .gif, and low resolution photographs, tagged as .jpg (.jpeg), downloaded from websites are not acceptable.
- PC Format: images must be in .bmp, .psd, .tif, .pdf, .eps, .ai (Illustrator only) [Adobe InDesign does not read Illustrator .eps files], submitted via email, disk or CD-ROM. Make sure art is B&W or CMYK, not RGB color. If sending via email, please compress artwork using .zip software. Files in .txt cannot be used.
- MAC Format: images must be in .tif, .pdf, .psd, .eps, high-resolution .jpeg, .ai (Illustrator only) Make sure art is B&W or CMYK, not RGB color.
- We cannot accept digital figures created in CAD, Visio or other drafting programs.
- We cannot accept figures only as embedded graphics in a Word or multi-page PowerPoint document. They must be submitted in the formats noted above. PowerPoint figures submitted with one page per file are acceptable.
- All figures in your article must be accompanied by high-quality laser prints, even if they have been submitted digitally.
- Figure legends must be included with the figures. All necessary symbols, notations and axes must be of sufficient size to be legible when reduced for publication. Figures are referenced in the text by Arabic numbers, in consecutive order, e.g., Figure 1, Figure 2. Please label your figures as such.
- Tables: Excel tables are preferred. Only simple or text-heavy tables should be created in Word. If submitting the actual data to plot the figures or charts, the information must be provided in Excel and accompanied by a hard copy of the final figure or chart for design purposes.
- References must be numbered sequentially according to their appearance in the text and listed at the end of the article. Do NOT use the automatic endnote/footnote feature in Word. Reference format should follow the specific guidelines in the AMA Manual of Style, 10th edition.
- Figures, tables and endnotes are also prepared according to The AMA Manual of Style. If Web documents are used as sources, the date the document was accessed must be included in the citation.
- An author biographical summary of no more than three sentences must be submitted with the article. The summary must include current job title, years of experience in regulatory affairs and, if desired, a brief company description.
- Articles will be edited for style, content, grammar and punctuation. Regulatory Focus follows Associated Press (AP) editorial style.
- Each article is reviewed for quality and content by members of the Regulatory Focus Board of Editors. Authors have the opportunity to review the final version of the article before it is published. If no response with changes is received by the deadline for comments, the version provided will be published.
- Authors must sign a copyright release form transferring copyright ownership to RAPS before an article is published. (This does not apply to government employees.)