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The highly-anticipated fifth edition is here! Get the must-have resource for achieving compliance with medical device regulations.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Hear from the experts who wrote the second edition of Regulatory Writing: An Overview! Expert authors Lisa DeTora, Jocelyn Jennings and Jenny Grodberg will present the new edition’s writers-eye view of regulatory documentation that is intended to help writers, reviewers, and readers to better understand the varied aims and audiences of these complex documents. With a diverse body of knowledge and direct experience, they
The “writer” in these pages can be any professional engaged in designing, composing, compiling, or commenting on regulatory documentation. This second edition of Regulatory Writing is intended to help novice writers and provide a refresher and updates for more seasoned professionals.
The authors have cited relevant guidelines, guidance for industry, publication guides, and collaborative efforts to streamline, harmonize, and advance the production of high-quality regulatory documentation. Every chapter in Regulatory Writing: An Overview has been updated to reflect new regulations and guidance since the first edition went to press in 2017. These changes were substantial in several chapters, especially in the light of the COVID-19 public health emergency. The clinical study includes the new US guidance on study reporting requirements and carried this information forward to other documents, such as integrated summaries, that might be affected by the new requirements.
This book’s expanded scope better reflects the shared nature of regulatory documentation and the goal that individual documents may be used in dossiers worldwide. Many examples have been added to highlight requirements in Europe and the rest of the world, in addition to the US FDA requirements. The new edition features a chapter on lay summaries, a requirement in the EU which pairs with the existing chapter on pediatric investigation plans, as well as enhanced information about good documentation practices, accelerated filings, combination products, devices, safety update reporting, and dossier maintenance.
Don’t miss the opportunity to ask expert authors Lisa DeTora, Jocelyn Jennings and Jenny Grodberg all your regulatory writing questions!
Jennifer Grodberg, PhD, RAC (US)
Jennifer Grodberg, PhD, RAC (US) has over 27 years of experience in the pharmaceutical industry 17 years of it in Regulatory Affairs, As a regulatory affairs consultant, Jenny provides strategic and hands-on regulatory support for programs spanning the pre-IND enabling phase through NDA/BLA submissions. Her past positions include that of Sr. Vice President of Regulatory Affairs and Program Management at Forge Therapeutics, Inc., Vice President of Regulatory Affairs at VenatoRx Pharmaceuticals, and positions of increasing responsibility during her tenure at Trius Therapeutics, Inc., where she participated in the development and ultimate FDA approval of the oxazolidinone antibiotic Sivextro. Before entering the pharmaceutical industry, Jenny held a faculty appointment at Harvard Medical School in the Department of Medicine. Jenny has a PhD in Microbiology and completed postdoctoral work at both the Weizmann Institute of Science in Rehovot, Israel, and Harvard Medical School. Jenny is past-president of the American Medical Writers Association Pacific Southwest Chapter and obtained her US RAC certification in 2007.
Jenny currently serves on the San Diego Regulatory Network Board of Directors as VP of mentoring and has been a volunteer mentor in the SDRAN mentoring program since 2011.
Jocelyn Jennings, MS, RAC
Jocelyn Jennings, MS, RAC (US, DRUGS, DEVICES) is a regulatory affairs professional working for a global healthcare company developing pharmaceutical products for unmet needs. Ms. Jennings has over 22 years of extensive global regulatory affairs, quality assurance and global clinical trial experience in drugs, biologics and medical devices. Ms. Jennings is an adjunct professor at Northeastern University College of Professional Studies in the Masters of Regulatory Affairs Program. Ms. Jennings is actively involved as a volunteer with the Regulatory Affairs Professional Society (RAPS); writing chapters for their regulatory books and writing online courses. Ms. Jennings obtained her BS degree in Biology from Notre Dame College, her MS in Regulatory Affairs from Northeastern University and has her Regulatory Affairs Certification.
Lisa M DeTora, PhD
Lisa M DeTora, PhD, is an associate professor and the director of STEM Writing at Hofstra University in Hempstead, NY, where she also serves as guest faculty in humanities at the Hofstra Northwell Medical School. She began her career in clinical development, regulatory writing, and biomedical publications at Merck and Co., Inc., while also completing her doctoral studies. At Merck, DeTora contributed to medical affairs policies and procedures development for the implementation of the Common Technical Document and the new ICH Clinical Study Report format. Since then, her professional experience has spanned multiple companies, pharmaceuticals, and vaccines, and all three major ICH disciplines. Currently, DeTora is serving as a member of the Good Publication Practice 4 Steering Committee for the International Society of Medical Publications Professionals and the advisory board for the International Publication Planning Association meeting. She also co-organizes the Symposium for Communicating Complex Information. DeTora’s publications include work in publication ethics, technical communication, the rhetoric of health and medicine, health and medical humanities, as well as research into graphic narratives, film, and teaching.