Regulatory Intelligence Reimagined
viii Regulatory Affairs Professionals Society
Chapter 13 Discovering Regulatory Intelligence Within Your Records ....................................................................................85
Patterson Shafer Purba Ganguly, MSc, CPhT
Chapter 14 Regulatory Intelligence: How to Measure Success...................................................................................................93
Linda Bowen, MS, RAC-CAN, RAC-EU, RAC-US, FRAPS James Lindsay Cobbs, RPh Purba Ganguly, MSc, CPhT
Chapter 15 Monitoring, Analyzing, and Interpreting Regulatory Trends ..................................................................................97
João Duarte, MSc, MPharm, FTOPRA, FRAPS Kirsten Messmer, PhD, RAC-US Marco Rafael, PharmD, MBA
Section 3 Supporting Health Authority Interactions. ...............................................................105
Chapter 16 Creating More Strategic Submissions Through FDA Division and Reviewer Profiling. .......................................107
Virginia Cox, JD Lindsay Simon, RAC-Drugs
Chapter 17 Creating More Effective Health Authority Meetings Through Participant Profiling. ...........................................111
Michelle Zucatti, MHA
Chapter 18 Public Sources of Regulatory Precedent.................................................................................................................117
Linda Bowen, MS, RAC-CAN, RAC-EU, RAC-US, FRAPS Robert F. Kester, MS
Chapter 19 Applications of Regulatory Precedent Research.....................................................................................................131
Anusha Kesireddy, PhD, MS, BPharm Hannah Hapner Hogan, MSc Thomas Stover, PhD, MBA
Chapter 20 Supporting Device Development and Approval Pathway Strategies......................................................................137
Andrew C. Wingen, MS, RAC-Global Kenneth G. Butz, MS
Chapter 21 Regulatory Intelligence’s Role in Preparing the Due Diligence Team. ..................................................................143
Kirsten Messmer, PhD, RAC-US
Section 4 The Policy Side.................................................................................................................. 155
Chapter 22 Introduction to Regulatory Policy..........................................................................................................................157
Joshua S. Silverstein, PhD Alex May, MS
Chapter 23 Leveraging Collective Influence in Regulatory Policy: The Value of Engaging With External Stakeholders. .......161
Pedro Franco, PhD, PharmD, MBA, MSc Andrew C. Wingen, MS, RAC-Global Raya D. Zerger, MT(ASCP)SBB
Chapter 24 Best Practices in Commenting...............................................................................................................................167
Soufiane Dib, PharmD Emily Huddle, BSc Joshua S. Silverstein, PhD
Chapter 25 Development of White Papers...............................................................................................................................175
Charity-Anne Metz Schuller, PharmD, MSCR, RAC-US
Section 5 The Intersection of Artificial Intelligence and Regulatory Intelligence.............. 179
Chapter 26 Artificial Intelligence and Its Potential in Regulatory Intelligence ......................................................................181
Amin Osmani, MSc, MSc
Chapter 27 Use of Artificial Intelligence/Machine Learning to Enhance Regulatory Intelligence Analysis Capabilities. .......191
Aleksandr Merenkov, PharmD, MS, MBA, RAC-Drugs Jeff MacDonald, PharmD, RPh
Chapter 28 Embracing the Digital Revolution: Applying AI and ML Technology Within the Regulatory
Intelligence Function.............................................................................................................................................207
Rudy Fuentes, PhD, RAC-US Amra Racic, MBA
Index .............................................................................................................................................213
viii Regulatory Affairs Professionals Society
Chapter 13 Discovering Regulatory Intelligence Within Your Records ....................................................................................85
Patterson Shafer Purba Ganguly, MSc, CPhT
Chapter 14 Regulatory Intelligence: How to Measure Success...................................................................................................93
Linda Bowen, MS, RAC-CAN, RAC-EU, RAC-US, FRAPS James Lindsay Cobbs, RPh Purba Ganguly, MSc, CPhT
Chapter 15 Monitoring, Analyzing, and Interpreting Regulatory Trends ..................................................................................97
João Duarte, MSc, MPharm, FTOPRA, FRAPS Kirsten Messmer, PhD, RAC-US Marco Rafael, PharmD, MBA
Section 3 Supporting Health Authority Interactions. ...............................................................105
Chapter 16 Creating More Strategic Submissions Through FDA Division and Reviewer Profiling. .......................................107
Virginia Cox, JD Lindsay Simon, RAC-Drugs
Chapter 17 Creating More Effective Health Authority Meetings Through Participant Profiling. ...........................................111
Michelle Zucatti, MHA
Chapter 18 Public Sources of Regulatory Precedent.................................................................................................................117
Linda Bowen, MS, RAC-CAN, RAC-EU, RAC-US, FRAPS Robert F. Kester, MS
Chapter 19 Applications of Regulatory Precedent Research.....................................................................................................131
Anusha Kesireddy, PhD, MS, BPharm Hannah Hapner Hogan, MSc Thomas Stover, PhD, MBA
Chapter 20 Supporting Device Development and Approval Pathway Strategies......................................................................137
Andrew C. Wingen, MS, RAC-Global Kenneth G. Butz, MS
Chapter 21 Regulatory Intelligence’s Role in Preparing the Due Diligence Team. ..................................................................143
Kirsten Messmer, PhD, RAC-US
Section 4 The Policy Side.................................................................................................................. 155
Chapter 22 Introduction to Regulatory Policy..........................................................................................................................157
Joshua S. Silverstein, PhD Alex May, MS
Chapter 23 Leveraging Collective Influence in Regulatory Policy: The Value of Engaging With External Stakeholders. .......161
Pedro Franco, PhD, PharmD, MBA, MSc Andrew C. Wingen, MS, RAC-Global Raya D. Zerger, MT(ASCP)SBB
Chapter 24 Best Practices in Commenting...............................................................................................................................167
Soufiane Dib, PharmD Emily Huddle, BSc Joshua S. Silverstein, PhD
Chapter 25 Development of White Papers...............................................................................................................................175
Charity-Anne Metz Schuller, PharmD, MSCR, RAC-US
Section 5 The Intersection of Artificial Intelligence and Regulatory Intelligence.............. 179
Chapter 26 Artificial Intelligence and Its Potential in Regulatory Intelligence ......................................................................181
Amin Osmani, MSc, MSc
Chapter 27 Use of Artificial Intelligence/Machine Learning to Enhance Regulatory Intelligence Analysis Capabilities. .......191
Aleksandr Merenkov, PharmD, MS, MBA, RAC-Drugs Jeff MacDonald, PharmD, RPh
Chapter 28 Embracing the Digital Revolution: Applying AI and ML Technology Within the Regulatory
Intelligence Function.............................................................................................................................................207
Rudy Fuentes, PhD, RAC-US Amra Racic, MBA
Index .............................................................................................................................................213