Need the basics of pharmaceutical regulations or devices? RAPS’ product area books cover everything

RAPS’ Fundamentals of Regulatory Affairs book series has been a trusted reference for regulatory professionals for more than two decades since the publication of the first edition of Fundamentals of US Regulatory Affairs. Over the years, other titles have been added to the series, covering not only US regulations, but also those of the EU as well as important international standards.

Originally, each fundamentals book covered the entire regulatory landscape of a country or region. As regulatory professionals specialize in certain industries, so do the books in the RAPS Fundamentals series.

Fundamentals for your area of ​​interest

Responding to need, RAPS offers industry-specific foundational products—Fundamentals of Pharmaceutical and Biological Regulation and Fundamentals of medical device regulation. The first is composed of all the pharmaceutical and biological chapters of all the current fundamental books. The latter includes all chapters on medical devices. Fourth editions of both books came out this summer.

Expert authors discuss the value of fundamentals

Both industry fundamentals books feature newly updated content from Fundamentals of International Regulatory Affairs, Fifth Edition, published this year. At this year’s RAPS Convergence, several regulatory experts who have authored chapters included in international and industry-specific books participated in a virtual “meet the authors” session. They offered information about their chapters and areas of expertise, as well as the general usefulness of the entire fundamentals series, including the product-focused editions.

An authoritative resource

One of the main advantages highlighted by the authors is that the books in the series are authoritative and save valuable time for readers. “We have a million other things going on,” said the author, Monique Carter, MS, RAC, senior director, global regulatory affairs, global product development, Pfizer. “And one thing that I think is beneficial is that we actually have subject matter experts who curated the text and the content.”
All of the books feature multiple authors, each with different areas of regulatory expertise, so in these texts readers have access to not just one or two experts, but dozens. “I think what’s wonderful is that you have a wide range of writers who have a lot of different backgrounds and can put that to good use,” said author, Jocelyn Jennings, MS, RAC, director Deputy, Regulatory Coordination, Grifols Therapeutics LLC.

Why not just Google?

Some may wonder why these books are needed in today’s interconnected world. “You may ask ‘why should I get the book rather than just googling? commented author, Treena Jackson, MS, MA, CQA, RAC, CSSGB, President, Quality Resource Consulting Inc. not qualified and others who are,” Jackson said. Basic books save you from having to spend the time, energy, money, and resources to properly check sources online, because the authors have already done that for you.

Basic books go beyond helping you find the right information. They also help readers understand the regulations and their context. “It’s really like an encyclopedia, not just with references, but with lots of explanations,” said author Siegfried Schmitt, PhD, technical vice president, Parexel.

Of course, in a resource that covers as much ground as the fundamentals books, including the two product area books, it’s impossible to include every detail of every topic or answer every question, but with these books as a reference resource, it puts you in a position to know where to look. “If he doesn’t have everything you need, he can start you on the path to finding the rest,” Jennings said.

The Fundamentals of Pharmaceuticals and Biologicals Regulation and The Fundamentals of Medical Devices Regulation are available in print and electronic versions for $295 for RAPS members and $395 for non-members.

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