Regulatory Intelligence Reimagined
vii Regulatory Affairs Professionals Society
Contents
Section 1 The Basics. ..............................................................................................................................1
Chapter 1 A General Framework for Regulatory Intelligence in Medical Product Research and Development........................3
Chris Whalley
Chapter 2 Paving Your Path in Regulatory Intelligence: Skill Development and Transition Strategies....................................11
Brandy Proctor, MS
Chapter 3 Establishing a Robust Regulatory Intelligence Function ........................................................................................19
Joseph M. Thomas, PhD Tony E. Catka, PhD Patrick Frey
Chapter 4 Scoping Regulatory Intelligence Deliverables. .........................................................................................................27
Alex May, MS
Chapter 5 Establishing Key Performance Indicators to Advocate for a Dedicated Regulatory Policy and
Intelligence Function...............................................................................................................................................31
Patterson Shafer
Chapter 6 Homegrown Regulatory Intelligence Tools..............................................................................................................39
John Joines, RPh Sean Schofield, PharmD, MS
Chapter 7 Regulatory Intelligence Tools...................................................................................................................................43
Sam Kay, MPharm Charity-Anne Metz Schuller, PharmD, MSCR, RAC-US
Section 2 Deliverables.........................................................................................................................51
Chapter 8 Monitoring and Surveillance....................................................................................................................................53
Elayne Kimmett, MBA, CQA, RAC-Global Joseph M. Thomas, PhD
Chapter 9 FOIA and Access to Information ...........................................................................................................................59
Rachel Cuccias, MS
Chapter 10 Partnering With SMEs on Impact Analysis. ...........................................................................................................69
Eliza Shearer Stephanie Sabatino Kelly, JD, MS
Chapter 11 Regulatory Intelligence Distribution and Communication......................................................................................73
Lieselotte L. Bloss, DVM Chelsea Miller, MA
Chapter 12 What Is Regulatory Research, and Why Is It Important?........................................................................................77
Tom Dillane, MSc Kieran Maher, MSc João Duarte, MSc, MPharm, FTOPRA, FRAPS
vii Regulatory Affairs Professionals Society
Contents
Section 1 The Basics. ..............................................................................................................................1
Chapter 1 A General Framework for Regulatory Intelligence in Medical Product Research and Development........................3
Chris Whalley
Chapter 2 Paving Your Path in Regulatory Intelligence: Skill Development and Transition Strategies....................................11
Brandy Proctor, MS
Chapter 3 Establishing a Robust Regulatory Intelligence Function ........................................................................................19
Joseph M. Thomas, PhD Tony E. Catka, PhD Patrick Frey
Chapter 4 Scoping Regulatory Intelligence Deliverables. .........................................................................................................27
Alex May, MS
Chapter 5 Establishing Key Performance Indicators to Advocate for a Dedicated Regulatory Policy and
Intelligence Function...............................................................................................................................................31
Patterson Shafer
Chapter 6 Homegrown Regulatory Intelligence Tools..............................................................................................................39
John Joines, RPh Sean Schofield, PharmD, MS
Chapter 7 Regulatory Intelligence Tools...................................................................................................................................43
Sam Kay, MPharm Charity-Anne Metz Schuller, PharmD, MSCR, RAC-US
Section 2 Deliverables.........................................................................................................................51
Chapter 8 Monitoring and Surveillance....................................................................................................................................53
Elayne Kimmett, MBA, CQA, RAC-Global Joseph M. Thomas, PhD
Chapter 9 FOIA and Access to Information ...........................................................................................................................59
Rachel Cuccias, MS
Chapter 10 Partnering With SMEs on Impact Analysis. ...........................................................................................................69
Eliza Shearer Stephanie Sabatino Kelly, JD, MS
Chapter 11 Regulatory Intelligence Distribution and Communication......................................................................................73
Lieselotte L. Bloss, DVM Chelsea Miller, MA
Chapter 12 What Is Regulatory Research, and Why Is It Important?........................................................................................77
Tom Dillane, MSc Kieran Maher, MSc João Duarte, MSc, MPharm, FTOPRA, FRAPS