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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Download your copy of the new events calendar and see all the online workshops, conferences, RAC exams and European online workshops RAPS has planned for 2021 at a glance.
Registration is now open for RAPS Euro Convergence 2021! Attend to join peers from EU and around the world to gain insights and exchange ideas on the regions most pressing issues.
An invaluable resource for any professional engaged in designing, composing, compiling, or commenting on regulatory documentation
From self-assessments to help you identify your strengths and areas to focus on to reference books and online courses that will help you fill in the gaps in your regulatory knowledge, RAPS has the resources to help you prepare for the RAC exam.
Download the Guidelines PDF Last updated 9 September 2020
Regulatory Focus (RF) is the flagship online publication of the Regulatory Affairs Professionals Society (RAPS). It provides in-depth feature articles for those involved with the regulation of healthcare and related products, including pharmaceuticals, medical devices, biologics, biotechnology, in vitro diagnostic devices, nutritional products, cosmetics, veterinary products, and related fields.
RF provides ongoing access to timely information addressing real-world issues in the regulatory environment. It is the only source of timely, quality regulatory news, information, and analysis fully dedicated to covering regulatory issues associated with healthcare products and the regulatory profession.
The publication is delivered digitally on the RAPS website (www.raps.org).
Areas of interest to our readers
Articles are written by industry professionals and reviewed by a body of volunteer technical reviewers, including the RAPS Editorial Advisory Committee, consisting of experts in regulatory subject matter from around the world. About 10 feature articles are published each month, and there is a 12-month editorial calendar focusing on key topical areas and emerging issues.
RAPS members can benefit from in-depth examination and analysis of regulatory and related topics with monthly themes in addition to continuous access to feature articles, guest editorials, perspectives, opinion pieces, case studies, and research studies.
RF accepts unsolicited articles but does not guarantee publication of all submissions. It is preferred a prospective author first submit a two- to three-sentence synopsis of the fact-based, in-depth article topic specifying its relevance to the regulatory profession. This information can be emailed to Renée Matthews, Senior Editor, Regulatory Focus, at rmatthews@raps.org.
AUTHOR GUIDELINES (Also see Presubmission Author Checklist below) Download the Guidelines PDF
Article presentation Length Articles should run to at least 2,000 words, including references but excluding tables. Most articles submitted range between 2,800 and 3,500 words (6-8 pages as per specs outlined under the Format heading below).
Format
Elements
○ Level 1 subheads – bold typeface ○ Level 2 subheads – bold, italic typeface
Biography A biographic summary for each author, of no more than three or four sentences, should be submitted with the article. The summary should include current job title, years of experience in regulatory affairs, area of responsibility, graduate degrees, professional affiliations, and contact email.
Commercialism Commercialism is strictly prohibited. Commercialism is deemed to be the inclusion of visual, written, or verbal references to any specific company and/or product for its promotion or commercial advantage. Articles promoting a specific product or company will not be accepted.
Correctness and accuracy Authors are responsible for the correctness and accuracy of all statements contained in the article (the publisher assumes no liability). Accepted articles become the property of the publisher and may not be published elsewhere without the written permission of both the author and publisher.
Figures and tables Only figures and tables meeting the following criteria will be accepted:
Keywords Each article should include four to six keywords, in alphabetical order.
Ownership Authors must sign a copyright release form transferring copyright ownership to RAPS before an article is published. (This does not apply to government employees.)
Payment RAPS does not pay any financial remuneration to authors.
Permissions Authors wishing to include figures, tables or text passages that already have been published elsewhere are required to obtain permission from the copyright owner(s) and to include evidence that such permission has been granted when submitting their articles. Any material received without such evidence will be assumed to originate from the authors.
Recertification RACs earn five recertification points for each article published.
Reprints After the article has been published, it may be posted on the author’s company website. Contact the editor for more information.
Technical and editorial review All articles published in Regulatory Focus undergo double-blind peer review. Each article is reviewed by at least three reviewers from a pool of technical reviewers for timeliness, quality of presentation, relevance to audience, technical accuracy, and areas for improvement.
Reviewers evaluate submissions and provide feedback on the article, suggest improvements, and make a recommendation to the senior editor about whether to accept, reject, or request changes to the article. The ultimate decision rests with the senior editor, but reviewers play a significant role in determining the outcome.
After revisions and acceptance of the article, it will be edited for style, content, presentation of references, grammar, and punctuation in accordance with the RAPS Style Guide. The article is sent to the lead author for proofing and sign-off before it is published.
STYLE GUIDE Abbreviations and acroynms Abbreviations and acronyms should follow the full spelling of the term in parentheses after first reference.
Example 1, The US Food and Drug Administration (FDA) is looking into the matter. (Note capitalization.) Example 2, … sponsors must submit a clinical trial application (CTA) for authorization. (Note use of lowercase.)
Note, if the abbreviation is for an established group or agency, then the first letter of each world words of its name are title capitalize when written out in full.
For each subsequent reference, use only the abbreviation. If the name is referenced only once, there is no need to include the abbreviation after that single reference.
Acronyms are abbreviations that can be pronounced as words, for example, AIDS, COVID, and NASA. RAPS style is to use uppercase for acronyms as well, although some publications use title case for acronyms of four letters or more, as with a proper noun.
Some common abbreviations that need not be spelled out at first mention would include COVID-19 and HIV-AIDS.
Degrees and credentials Periods are not used in abbreviations for educational degrees or certifications, e.g., PhD, MBA, RAC. Note: avoid prefixes, including Dr.
The United States, United Kingdom, and the European Union Abbreviate as US, UK, and EU, respectively, and use without periods. The abbreviations can be used both as nouns and as adjectives.
Capitalization Commonly used words Cabinet, Congress, Federal Register
Do not capitalize: agency congressional mark, marked, marking in reference to the CE Mark ministry quality assurance regulatory affairs sponsor treaty, act, regulation, federal (unless in title)
Clinical trial phases Phases of clinical trials are identified using Arabic numerals and lowercase for “phase” – phase 1, phase 2, phase 3.
Contractions Limit use of contractions, such as “don’t” and “isn’t,” except in direct quotations. Spell out “do not,” “is not,” etc.
Dates Use the international style for dates for all RAPS documents, e.g., 16 February 1971. Spell out the months ‒ do not use abbreviations unless space considerations make it absolutely necessary. Do not use numerical dates, e.g., 2/16/1971.
Degrees and certifications Generally, include an individual’s credentials for doctorates (PhD), medical degrees (MD), doctor of pharmacy degrees (PharmD) and Regulatory Affairs Certification (RAC).
If referring to or quoting a lawyer, it is acceptable, but not mandatory, to indicate the JD. Do not include any degree lower than a master’s level.
Offset a person’s degree with a comma. Do not use periods in abbreviations of degrees and credentials, e.g., PhD, JD, MD. Do not use prefixes, including Dr.
Emphasis Do not use uppercase, boldface, or italics as a device to emphasize a point.
Gender-specific pronouns Often sentences can be constructed so no gender-specific pronoun is necessary, e.g., “Regulatory professionals make important contributions to their employers’ organizational strategies…” instead of “… a regulatory professional makes an important contribution to his or her employer’s organizational strategy…”.
Use “his or her” or “he or she” only when absolutely necessary. Avoid using a construction such as “he/she.” When referring to an individual, never use “their.”
Medical devices Classifications Medical device classes are identified using Roman numerals, and “Class” is capitalized, i.e., Class I, Class II, etc.
510(k) clearance When referring to the US Food and Drug Administration’s clearance of medical devices through the 510(k) process, always use the term “clearance” or “cleared.” Do not use “approval” or “approved.”
Numbers Cardinal (one, two, three, etc.) and ordinal numbers (first, second, third, etc.) from one to nine should be spelled out if they are not used with a unit, such as 3 miles, 6.2 kg.
Numbers 10 and higher should be written as numerals (10, 11, 12, etc.).
Punctuation Bulleted lists When creating a vertical bulleted list, RAPS adheres strictly to The Chicago Manual of Style. This reference states that no punctuation is to follow a bulleted list if the list contains words, phrases or sentence fragments.
Bulleted lists that are not complete sentences are not capitalized.
If the bulleted or numbered list contains complete sentences (subject and verb), capitalize the first letter and place a period after each item in the list.
Comma Use the serial comma.
Hyphen Reference a dictionary or guidance on whether a word is used as one word; two separate words; or two words, hyphenated.
There are a few terms that are always written as one word in RAPS style even though they are used elsewhere as two words, e.g., healthcare, drugmaker, and lifecycle.
Note use of the hyphen in the following:
Asia-Pacific benefit-risk cosponsor e-book, email decision making direct-to-consumer (adjectivally) drugmaker FDA-approved (drug, biologic, and PMA submissions) FDA-cleared (510(k) submissions) First-in-Man healthcare lifecycle multicenter, multisite nonbinding, nonclinical, noncommunicable noninferiority on-site (adjectivally), on site (all other instances) over-the-counter (adjectivally) pre-authorization preapproval, preclinical, presubmission postauthorization, postapproval, postmarket, postsubmission roundtable shelf life subsection third-party (adjectivally), third party (as a noun) timeframe
Quotation marks and punctuation
References and text citations In Reference lists, please do not use endnotes or footnotes; auto-numbering; or italics or quote marks for titles.
If there are multiple sources for a document, use the source most likely to remain unchanged, e.g., for an FDA guidance, use the agency website instead of linking to a copy of the document on a consulting firm’s website.
○ Name of content originator, e.g., author or organization. ○ Title of document, sentence case – no italics or quotation mark. ○ Abbreviated journal name – single period at the end of the title, not italic. ○ Year;Volume(Issue):page range ○ Page range numbers are separated with a hyphen; don’t repeat duplicate numbers, e.g., pages 103 to page 109, would be 103-9; pages 1175-1190, would be 1175-90. ○ URL, if applicable – hyperlinked to source. ○ If a URL is used, include the date the item was published/posted/last updated or revised, e.g., Published 16 November 2019. Last updated 16 November 2019. ○ Also include the most recent date on which the article was accessed through the URL, e.g., Accessed 15 January 2020.
Style for specific references Journal article, print journal 5. Sun J, Li S-H, Liu S-M et al. Improvement in cardiac function after bone marrow cell therapy is associated with an increase in myocardial inflammation. Am J Physiol Heart Circ Physiol. 2009;296(1):43-50.
Journal article, online 7. Zhou P, Zhou J. The primary cilium as a therapeutic target in ocular diseases. Front Pharmacol. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7333185/. Published online 26 June 2020. Accessed 17 June 2010.
For website URLs 26. National Medical Products Administration. NMPA issued the 2019 annual report for medical device registration. http://english.nmpa.gov.cn/2020-03/17/c_471589.htm. Last updated 17 March 2020. Accessed 17 July 2020.
For website URLs when the document is in a language other than English 37. [In French]. Le Ministère de l’Education Nationale et de la Jeunesse et des Sports. Rentrée 2020: Modalités pratiques [Back to school 2020: Practical guidelines]. https://www.education.gouv.fr/rentree-2020-modalites-pratiques-305467. Last updated 19 August 2020. Accessed 17 July 2020.
Presentation at a conference 37. Du X, Blank B, Chan B, et al. Orally available small molecule CD73 inhibitor reverses immunosuppression through blocking of adenosine production. Paper presented at: American Association for Cancer Research Virtual annual meeting; 27 April 2020. https://www.abstractsonline.com/pp8/#!/9045/presentation/10523. Accessed 30 July 2020.
Book (whole) 25. Venables WN. Modern applied statistics with S. 4th ed. New York, NY: Springer Publishing Co; 2003.
Book chapter 17. Solensky R. Drug allergy: Desensitization and treatment of reactions to antibiotics and aspirin. In Lockey P, ed. Allergens and Allergen Immunotherapy. 3rd ed. New York, NY: Marcel Dekker; 2004:585-606.
Package insert 11. Qinlock [package insert]. Waltham, MA: Deciphera Pharmaceuticals; 2020. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213973s000lbl.pdf. Accessed 21 July 2020.
PRESUBMISSION AUTHOR CHECKLIST
Before submitting your article, please ensure that the following requirements have been met:
□ Formatting
□ Article is at least 2,000 words (including references, but excluding tables) □ Headline – no longer than 75 characters □ Byline – FirstName LastName, postgrad degrees □ Brief summary, abstract of article – no longer than 85 words □ Introduction to article includes topic background/context and purpose of article □ Text citations – superscripted numbers in increasing numerical order □ Tables – heading, notes, abbreviation list, source (if applicable) □ Figures – heading, legend, abbreviation list, source (if applicable) □ Level 1 subheads – bold typeface □ Level 2 subheads – bold, italic typeface □ Bulleted points – not numbered □ Abbreviations list in alphabetical order – after text, before Reference section □ References complete as per Author Guidelines □ References – URLs must be accompanied by publish/update/revise and access dates □ URLs – do they go to the correct source? □ Brief bio for each author
Thank you
For more information, contact: Renée Matthews, Senior Editor, Features, Regulatory Focus rmatthews@raps.org Regulatory Affairs Professionals Society, 5635 Fishers Lane, Suite 400, Rockville, MD 20852