iii
Contents
Preface ....................................................................................................................................................vii
Author Acknowledgments......................................................................................................................ix
Chapter 1: The Five Ws and H of Regulatory Intelligence...................................................................1
By Darin Oppenheimer, DRSc, RAC, PMP, George Cusatis, MS, RAC, and Suraj Ramachandran, MS, RAC
Chapter 2: Overview of Key Regulatory Agencies and How They are Organized................................7
By Oliver Steck, Gert Bos, MSc, PhD, FRAPS, Malka Fraiman, MSc, Mayura Gill, and James Biddlecombe
Chapter 3: Regulatory Strategy. ..........................................................................................................15
By William K. Sietsema, PhD, George Cusatis, MS, RAC, Jessica Hale, PharmD, and Andrew Leung, PharmD
Chapter 4: Background and Skill Set Needed for a Regulatory Intelligence Professional. .................23
By Kirsten Messmer, PhD, RAC
Chapter 5: How to Set Up an RI Department....................................................................................33
By Céline Rodier Seguy, PharmD, DES
Chapter 6: The Basic Regulatory Intelligence Toolbox. .....................................................................41
By Daanish Ashraf, PharmD and Mary Nteris, PhD, GAICD
Chapter 7: Monitoring and Surveillance.............................................................................................45
By Jason Moore, MS, MBA, RAC
Chapter 8: The Regulatory Research Process......................................................................................53
By William K. Sietsema, PhD, Darin Oppenheimer, DRSc, RAC, PMP, George Cusatis, MS, RAC,
and Suraj Ramachandran, MS, RAC
Chapter 9: Professional Associations. .................................................................................................61
By Daanish Ashraf, PharmD and Mary Nteris, PhD, GAICD
Chapter 10: Public Sources of Regulatory Precedent............................................................................63
By Linda Bowen, MSc, RAC, FRAPS, João Duarte, MPharm, MSc, and Robert Kester, MS
Chapter 11: Regulatory Intelligence Databases. ...................................................................................81
By Susan Laufer, MSc
Chapter 12: Regulations and Guidance Documents.............................................................................93
By Daanish Ashraf, PharmD
Chapter 13: White Papers....................................................................................................................97
By Charity-Anne M. Schuller, PharmD, MS, RAC
Chapter 14: Freedom of Information (FOI) Request Overview.........................................................101
By Daanish Ashraf, PharmD, Mary Nteris, PhD, GAICD, and Charles Tam, MBA
Chapter 15: Successful Health Authority Meetings: Creating More Effective Meetings Through
Participant Profiling. .......................................................................................................111
By Michael Vivion, PhD
Contents
Preface ....................................................................................................................................................vii
Author Acknowledgments......................................................................................................................ix
Chapter 1: The Five Ws and H of Regulatory Intelligence...................................................................1
By Darin Oppenheimer, DRSc, RAC, PMP, George Cusatis, MS, RAC, and Suraj Ramachandran, MS, RAC
Chapter 2: Overview of Key Regulatory Agencies and How They are Organized................................7
By Oliver Steck, Gert Bos, MSc, PhD, FRAPS, Malka Fraiman, MSc, Mayura Gill, and James Biddlecombe
Chapter 3: Regulatory Strategy. ..........................................................................................................15
By William K. Sietsema, PhD, George Cusatis, MS, RAC, Jessica Hale, PharmD, and Andrew Leung, PharmD
Chapter 4: Background and Skill Set Needed for a Regulatory Intelligence Professional. .................23
By Kirsten Messmer, PhD, RAC
Chapter 5: How to Set Up an RI Department....................................................................................33
By Céline Rodier Seguy, PharmD, DES
Chapter 6: The Basic Regulatory Intelligence Toolbox. .....................................................................41
By Daanish Ashraf, PharmD and Mary Nteris, PhD, GAICD
Chapter 7: Monitoring and Surveillance.............................................................................................45
By Jason Moore, MS, MBA, RAC
Chapter 8: The Regulatory Research Process......................................................................................53
By William K. Sietsema, PhD, Darin Oppenheimer, DRSc, RAC, PMP, George Cusatis, MS, RAC,
and Suraj Ramachandran, MS, RAC
Chapter 9: Professional Associations. .................................................................................................61
By Daanish Ashraf, PharmD and Mary Nteris, PhD, GAICD
Chapter 10: Public Sources of Regulatory Precedent............................................................................63
By Linda Bowen, MSc, RAC, FRAPS, João Duarte, MPharm, MSc, and Robert Kester, MS
Chapter 11: Regulatory Intelligence Databases. ...................................................................................81
By Susan Laufer, MSc
Chapter 12: Regulations and Guidance Documents.............................................................................93
By Daanish Ashraf, PharmD
Chapter 13: White Papers....................................................................................................................97
By Charity-Anne M. Schuller, PharmD, MS, RAC
Chapter 14: Freedom of Information (FOI) Request Overview.........................................................101
By Daanish Ashraf, PharmD, Mary Nteris, PhD, GAICD, and Charles Tam, MBA
Chapter 15: Successful Health Authority Meetings: Creating More Effective Meetings Through
Participant Profiling. .......................................................................................................111
By Michael Vivion, PhD