Updated Regulatory Writing Book Now Available

RAPS AnnouncementsRAPS AnnouncementsRAPSRAPS' Latest | 04 December 2020 |  By 

It isn’t easy to be a highly effective regulatory writer, but clear, well-written documentation is a critical part of bringing essential medicines and medical products to market. In RAPS’ newly released, Regulatory Writing: An Overview, Second Edition, aspiring and experienced writers alike will find expert guidance and advice that is easy to apply.

Completely updated from the previous edition, Regulatory Writing covers content development for regulatory documents in various specialties, including chemistry, manufacturing, and controls (CMC), clinical, nonclinical, labeling, vaccines, lay summaries, and publications. The book includes 30 chapters from regulatory writing experts with a diverse base of knowledge and extensive direct experience.

Regulatory writing is complex and requires a unique mix of expertise and communications skills. “Any contributor to regulatory documents must have a basic understanding of such writing, but high-level mastery is rare,” writes editor, Lisa DeTora, PhD, in the book’s foreword. “An understanding of writing is not enough, nor is subject matter expertise or knowledge of regulations. The best regulatory authors and editors successfully balance content, regulations, and writing; information that is constantly changing.”

Regulatory writers must understand a wide range of areas, including research, law, and guidance documents from regulators, as well as the basic ethics of pharmaceutical, vaccine, biologic, and medical device development. But that broad knowledge base and strong communications skills are an asset to any regulatory team.

Thinking ahead and taking into consideration all documentation needs early in the process and throughout research and development does more than just strengthen the quality of a regulatory submission. It can also help improve the overall quality and efficiency of other aspects of regulatory work by ensuring clear communication among team members and important stakeholders, and ultimately, better inform healthcare providers and patients.

It is essential that reviewers be able to find important information quickly and easily. Regulatory teams must effectively convey knowledge of the research area, clinical realities, and the development process. Regulatory reviewers must clearly understand benefit-risk analyses to make informed decisions.

Regulatory writing is a team effort. It is the job of the regulatory team to build a credible, accurate, and clear case for a submission. Regulatory Writing was written not only for those dedicated to regulatory documentation but for anyone on a regulatory team who needs to understand how to communicate a product’s story clearly and efficiently.

The book’s authors also point readers to additional resources, including relevant guidelines, guidance, publication guides, and more, to further advance regulatory writing knowledge and skills.

DeTora, and two of the book’s authors, Jennifer Grodberg, PhD, RAC, and Jocelyn Jennings, MS, RAC, will participate in a free Meet the Authors Webcast, 8 December, to answer questions and provide additional insight.

Regulatory Writing: An Overview, Second Edition, is available from the RAPS Store in hardcover or e-book formats, for $125.00 for RAPS members, $175.00 for nonmembers.


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