Need the fundamentals of pharma or device regulations? RAPS’ product-sector books have it covered

RAPS’ Fundamentals of Regulatory Affairs series of books 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, more titles have been added to the series, covering not only US regulations, but also those in the EU as well as important international standards.

Originally, each fundamentals book covered the full regulatory landscape in a country or region. As regulatory professionals have specialized in certain sectors, so too have the books in RAPS’ fundamentals series. 

Fundamentals for your area of focus

Responding to fill the need, RAPS offers sector-specific fundamentals products—Fundamentals of Pharmaceutical and Biologics Regulations and Fundamentals of Medical Device Regulations. The former is comprised of all the pharmaceutical and biologics chapters from all current fundamentals books. The latter includes all the medical device chapters. The fourth editions of both books were released this summer.

Expert authors discuss the value of Fundamentals

Both of the sector 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 authored chapters included in both the international and sector-specific books participated in a virtual ‘meet the authors’ session. They offered insights on their chapters and areas of expertise, as well as the general utility of the entire fundamentals series, including the product-oriented editions.

An authoritative resource

One of the key advantages the authors pointed to is that books in the series are authoritative and save readers precious time. “We have a million other things going on,” said author, Monique Carter, MS,RAC, senior director, global regulatory affairs, global product development, Pfizer. “And one thing 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 get access to not just one or two experts, but dozens. “I think that's the wonderful thing about it is you have a wide breadth of authors that have a lot of different experiences and can bring that to bear,” said author, Jocelyn Jennings, MS, RAC, deputy director, regulatory coordination, Grifols Therapeutics LLC.

Why not just Google it?

Some may question why these books are necessary in today’s interconnected world. “You may ask ‘why should I get the book versus just Googling?’” commented author, Treena Jackson, MS, MA, CQA, RAC, CSSGB, president, Quality Resource Consulting Inc. But in searching for information on the internet, “you're going to get peoples’ opinions—some that are not qualified and some that are,” said Jackson. The fundamentals books save you from having to spend time, energy, money, and resources to properly vet online sources, because the authors have already done that for you.

The fundamentals books go beyond just helping you find the right information. They also help readers understand the regulations and their context. “This is really like an encyclopedia not just with references, but with a lot of explanations,” said author, Siegfried Schmitt, PhD, vice president technical, Parexel.

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

Fundamentals of Pharmaceutical and Biologics Regulations and Fundamentals of Medical Device Regulations are available in print and e-book versions for $295 for RAPS members, and $395 for nonmembers.