vii
Preface
Welcome to the third edition of Regulatory Intelligence 101. The demand for a third edition is a tes-
tament to the popularity of this topic and to the rapid evolution of information technology which is
changing the way regulatory information is gathered and interpreted.
As with previous editions, Chapter 1 opens with a discussion of what regulatory intelligence is and
why regulatory intelligence can be an important endeavor. Chapter 2 and Chapter 3 lay a foundation
with overviews of key regulatory agencies around the globe, how they are structured and organized, and
how regulatory intelligence is an integral component of regulatory strategy. This theme continues with
Chapter 8, which discusses why regulatory research can be an important process contributing to regu-
latory intelligence and regulatory strategy and Chapter 24, which examines how actionable regulatory
intelligence contributes to development of regulatory strategies.
Chapter 4 gets down to basics with a discussion of the education required to be a regulatory intel-
ligence professional and an inventory of skill sets needed for success. Key among these are leadership,
communication skills, ability to think strategically and critically, attention to detail, and self-motiva-
tion. Chapter 6 takes a detailed look at the toolbox needed by regulatory intelligence professionals and
discusses sources of information and useful tips on conducting intelligence searches.
Chapter 5 provides step-by-step guidance on how to create a regulatory intelligence department,
how to define its scope, identify stakeholders, and how to manage its operations effectively. Chapter
7 discusses how routine monitoring and surveillance of the regulatory environment can be established
and how the information can be disseminated to customers of the regulatory intelligence department.
This theme continues in Chapter 20, which focuses on how regulatory intelligence information can
be distributed to stakeholders. Further, Chapter 21 examines how one can use metrics to improve the
effectiveness of a regulatory intelligence department.
Chapter 9 discusses the contributions which professional associations make to education and
training of regulatory intelligence professionals and their research. A key example of this is how RAPS
has commissioned this book on regulatory intelligence and other regulatory topics. This theme is con-
tinued in Chapter 19, which discusses teaching and educational forums, how they can be organized,
and how they can be used as sources of information not readily available elsewhere.
Getting back into the operational aspects, Chapter 10 goes into detail on how precedent can be an
important source of insight on regulatory expectations and strategic product development. This chapter
also provides exhaustive detail on where to look for regulatory precedent on a country-by-country
basis. For those who wish to take full advantage of compilations of regulatory information, Chapter
11 presents many of the more popular regulatory intelligence databases, what they offer, and how they
can be used to speed regulatory information gathering and creation of regulatory intelligence. This
theme continues with Chapter 14 on gathering information through freedom of information requests
and Chapter 15 which examines how information from agency meetings can be used to understand
regulator expectations and beliefs.
Preface
Welcome to the third edition of Regulatory Intelligence 101. The demand for a third edition is a tes-
tament to the popularity of this topic and to the rapid evolution of information technology which is
changing the way regulatory information is gathered and interpreted.
As with previous editions, Chapter 1 opens with a discussion of what regulatory intelligence is and
why regulatory intelligence can be an important endeavor. Chapter 2 and Chapter 3 lay a foundation
with overviews of key regulatory agencies around the globe, how they are structured and organized, and
how regulatory intelligence is an integral component of regulatory strategy. This theme continues with
Chapter 8, which discusses why regulatory research can be an important process contributing to regu-
latory intelligence and regulatory strategy and Chapter 24, which examines how actionable regulatory
intelligence contributes to development of regulatory strategies.
Chapter 4 gets down to basics with a discussion of the education required to be a regulatory intel-
ligence professional and an inventory of skill sets needed for success. Key among these are leadership,
communication skills, ability to think strategically and critically, attention to detail, and self-motiva-
tion. Chapter 6 takes a detailed look at the toolbox needed by regulatory intelligence professionals and
discusses sources of information and useful tips on conducting intelligence searches.
Chapter 5 provides step-by-step guidance on how to create a regulatory intelligence department,
how to define its scope, identify stakeholders, and how to manage its operations effectively. Chapter
7 discusses how routine monitoring and surveillance of the regulatory environment can be established
and how the information can be disseminated to customers of the regulatory intelligence department.
This theme continues in Chapter 20, which focuses on how regulatory intelligence information can
be distributed to stakeholders. Further, Chapter 21 examines how one can use metrics to improve the
effectiveness of a regulatory intelligence department.
Chapter 9 discusses the contributions which professional associations make to education and
training of regulatory intelligence professionals and their research. A key example of this is how RAPS
has commissioned this book on regulatory intelligence and other regulatory topics. This theme is con-
tinued in Chapter 19, which discusses teaching and educational forums, how they can be organized,
and how they can be used as sources of information not readily available elsewhere.
Getting back into the operational aspects, Chapter 10 goes into detail on how precedent can be an
important source of insight on regulatory expectations and strategic product development. This chapter
also provides exhaustive detail on where to look for regulatory precedent on a country-by-country
basis. For those who wish to take full advantage of compilations of regulatory information, Chapter
11 presents many of the more popular regulatory intelligence databases, what they offer, and how they
can be used to speed regulatory information gathering and creation of regulatory intelligence. This
theme continues with Chapter 14 on gathering information through freedom of information requests
and Chapter 15 which examines how information from agency meetings can be used to understand
regulator expectations and beliefs.