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Regulatory Intelligence 101 authors stress importance of actionable info, communications, creativity

Posted 01 April 2021 | By Zachary Brousseau 

Regulatory Intelligence 101 authors stress importance of actionable info, communications, creativity

RAPS recently brought together three leading authors of the just-released, newly revised third edition of Regulatory Intelligence 101 to discuss the book and the practice of regulatory intelligence (RI). Author and global RI expert, Céline Rodier Seguy, joined lead editors, Daanish Ashraf and Bill Sietsema to answer questions and provide insight on keeping up with complex and constantly changing regulatory information, during a live webcast moderated by RAPS Senior Editor Gloria Hall.

Why is this book needed?

In addition to serving as a kind of how-to guide for RI professionals, Regulatory Intelligence 101 is designed to be a go-to resource for any regulatory professional to have at hand. “It has a lot of information about where to find particular types of intelligence,” said Sietsema. “The great value of this book is the fact that it centralizes lots and lots of information around regulatory intelligence, and it’s up to date because we know we are living in a world that is changing all the time,” said Rodier.

What’s new in this edition?

Each chapter has been extensively updated and rewritten, including chapters covering RI’s role in due diligence, how metrics can help measure success, RI databases, an overview of regulatory agencies and how they are organized, guidance documents, and important sources of information. “The resources for regulatory intelligence do evolve over time, and they have evolved since the previous edition,” said Ashraf.
In addition, new chapters have been added covering topics such as key skills RI professionals need, public sources of regulatory precedent, successful health authority meetings, teaching and educational forums and the current and emerging role of artificial intelligence (AI).

The editors also made it a point to ensure the new edition was more global. “The previous edition was focused to some extent on the United States,” said Sietsema. Including more information for professionals working in Europe, Australia, Asia and other regions was a priority, he said. “Making it more global and bringing in more global authors. That was one of the biggest focuses in updating the book,” said Ashraf.

Setting up a regulatory intelligence department

Regardless of the size of an organization, there are specific steps to efficiently set up an RI department, advised Rodier, who contributed a chapter on that topic. “It starts with mapping your stakeholders,” she said. “What are your customers’ needs? You need to know them, know their goals. You need to understand how they work, so you can best support them with your regulatory intelligence activities.” It is critical not only to share information, but to ensure it is actionable to stakeholders, she emphasized.

Important skills for regulatory intelligence pros

Asked about the key traits and skills needed to be successful in RI, the authors emphasized the importance of collaboration and communication skills. “It's one thing to find the answer to the question being asked,” said Ashraf. “It’s another thing to be able to communicate it to the person in the way that they need.” RI professionals also must think creatively and always be open to new ideas and new ways of doing things. “This is a continuously and evolving field, and there's a lot that that's emerging,” said Sietsema. Innovative and creative professionals will continue to find new methods, sources and processes to improve RI, he predicted.

Return on investment

While the authors agree that establishing an RI function does not necessarily require a large investment, they also argue that money spent on RI endeavors is well worth it. “The cost of noncompliance is huge,” said Rodier. “If you don’t invest in regulatory intelligence, you won't be compliant, you won't have robust regulatory strategies, and this will have a huge cost to your organization.” Being blindsided by not having the right information may be a painful lesson to learn, “but it reinforces the importance of having access to regulatory intelligence,” added Sietsema.

Sources of information

The book offers a comprehensive overview of RI resources, including options for all budgets. “For RI professionals, one of the toughest things to understand when you first get into the profession, and even when you are in the profession for a while, is ‘what are the best sources of information for you to look at?,’” said Ashraf. “So, a good portion of the book is dedicated to the best types of sources and locations of sources, both paid, and free and publicly available.”

“We have a chapter on public resources that is almost 20 pages, so we list a good number of these public resources that are free to use, that will provide a lot of the same information that is in the paid resources,” said Ashraf. “But they do require a bit more work and flexibility.”

Artificial intelligence and the future of regulatory intelligence

Artificial intelligence (AI) is becoming increasingly important, and one of the new chapters in this  edition serves as an introduction to the concept. It covers the meaning of things like machine learning and how they can be applied to RI now and in the future. “In five to 10 years, a lot of what we will be doing in regulatory intelligence and other parts of the pharmaceutical industry will be aided with AI,” said Ashraf, who edited the chapter and described it as “a great primer on things to come.”

Some may be concerned about the role of AI, but the authors advise regulatory professionals to embrace the technology and what it can do to aid their RI efforts. The experience and judgement of RI professionals will continue to be highly valuable. “I think in the end, it will just be another tool in the in the tool set for RI professionals,” said Ashraf. “It won't be supplanting their function.”

Regulatory Intelligence 101, Third Edition is available in print and e-book versions for $125.00 for RAPS members, and $175.00 for nonmembers.
 

 

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