3D Communications Contributes to New Edition of RAPS’ Essential Regulatory Affairs Text Book

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Fundamentals of US Regulatory Affairs, Seventh Edition now available

The Regulatory Affairs Professionals Society (RAPS) has published a new edition of its popular text, Fundamentals of US Regulatory Affairs, regarded by many as the essential reference guide to regulatory affairs for healthcare products marketed in the US.

Among the book’s authors are Cindy DiBiasi and Kell Cannon of 3D Communications. Fundamentals of US Regulatory Affairs, Seventh Edition, covers US regulatory requirements across healthcare product lines, including; pharmaceuticals, medical devices, biologics and other product classifications. Cindy and Kell wrote two chapters in the book: Chapter 4: FDA Communications and Meetings, and Chapter 5: Preparing for Key FDA Meetings and Advisory Committee Meetings.

“Based on 3D Communications’ years of experience helping companies succeed at FDA presentations, we know that sponsors need tools and processes to help them better navigate the heightened scrutiny in today’s ever-changing US regulatory environment,” said Cindy DiBiasi, partner at 3D Communications. “We wrote our chapters to be an informative and practical guide for pharmaceutical, biotech, and device companies that are preparing to interact with the FDA.”

The seventh edition of US Fundamentals has been updated to address current regulatory requirements from the US Food and Drug Administration (FDA) and other state and federal agencies, throughout the medical product lifecycle. New in this edition are chapters on Drug, Biologic and Device Regulatory Pathways; FDA Communications and Meetings; Patents and Exclusivity; and Veterinary Products.

“Advances in medical science and technology are happening faster than ever. Regulations and official guidances from FDA and other agencies overseeing the drugs, medical devices and other healthcare products we use every day are also evolving rapidly,” said RAPS Executive Director Sherry Keramidas, PhD, FASAE, CAE. “It is absolutely critical for regulatory professionals of all experience levels to have the most current information available, and Fundamentals of US Regulatory Affairs is an indispensible tool for both learning and reference.”

The book is well-suited to professionals new to US regulatory affairs, those preparing for the US Regulatory Affairs Certification (RAC) exam or those looking for a refresher or reference on US regulatory requirements, processes and concepts. It is used as an important training tool at many prominent healthcare organizations and is a mandatory text for many university-level courses.

Fundamentals of US Regulatory Affairs, Seventh Edition is available for purchase online from the RAPS Store for $239.95 with free shipping for RAPS members or $299.95, plus shipping, for nonmembers. It can also be purchased as part of an RAC (US) exam prep package. An updated e-book version will be available soon.

About RAPS
The Regulatory Affairs Professionals Society (RAPS) is an international membership organization of regulatory professionals in the rapidly growing medical device, pharmaceutical and biotechnology sectors. Regulatory professionals play vital roles in making better healthcare products possible. They work throughout the healthcare product lifecycle, ensuring these products are safe and effective, while driving organizational strategy and sound decision-making. RAPS supports these individuals and the regulatory profession by providing education and training, Regulatory Affairs Certification (RAC), professional standards, research, knowledge-sharing, publications, networking, career development opportunities and other valuable resources; and is committed to helping its members continually develop the knowledge and skills they need to excel. RAPS is headquartered near Washington, DC, with offices in Brussels and Tokyo. RAPS.org

About 3D Communications
3D Communications is a strategic communications firm that works with top executives and their teams across scientific, healthcare, technology, education, financial and business sectors to develop and deliver successful messages and presentations. For more information, visit http://www.3Dcommunications.us 3D has also written The FDA Advisory Committee Survival Manual: A Step-by-Step Guild to Preparing for a Successful FDA Meeting. ©3D Communications (2008).
Available at: http://www.3dcommunications.us/FDAsurvivalguide.html.


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