iv
Chapter 16: FDA Reviewer Profiles...................................................................................................125
By Daanish Ashraf, PharmD
Chapter 17: Inspection Tracking and Inspector Profiles. ....................................................................129
By Siegfried Schmitt, PhD and David Husman, PhD, ASQ CPGP, RAC
Chapter 18: Regulatory Intelligence Role in Due Diligence..............................................................141
By Kirsten Messmer, PhD, RAC
Chapter 19: Teaching and Educational Forums..................................................................................153
By Daanish Ashraf, PharmD and Mary Nteris, PhD, GAICD
Chapter 20: Regulatory Intelligence Distribution...............................................................................157
By Daanish Ashraf, PharmD
Chapter 21: Regulatory Intelligence Metrics: How to Measure Success. ...........................................161
By Linda Bowen, MSc, RAC, FRAPS
Chapter 22: Introduction to Regulatory Policy...................................................................................165
By Kristin Van Goor, PhD
Chapter 23: How to Comment...........................................................................................................169
By Daanish Ashraf, PharmD
Chapter 24: Providing Actionable Regulatory Intelligence in Developing Regulatory Strategies. .....173
By Linda Bowen, MSc, RAC, FRAPS, João Duarte, MPharm, MSc, and Anne Vinther Morant, PhD, MSc
Chapter 25: Current and Emerging Role of Artificial Intelligence in Regulatory Intelligence...........179
By Oliver Steck, Elina Sarmah, MS, Reid D’Amico, PhD, and Colin Spence
Index....................................................................................................................................................187
Figures
Figure 1-1. Regulatory Intelligence Process. ............................................................................................5
Figure 2-1. US FDA Organizational Structure........................................................................................8
Figure 2-2. Brazil ANVISA Organizational Structure...........................................................................10
Figure 2-3. EMA Organizational Structure...........................................................................................11
Figure 2-4. China NMPA Organizational Structure.............................................................................12
Figure 5-1. RI Department Activities. ...................................................................................................33
Figure 5-2. Steps in Setting Up an RI Department. ..............................................................................34
Figure 5-3. RI Department Stakeholder Engagement. ..........................................................................34
Figure 5-4. Minimum Requirements for an RI Department..................................................................35
Figure 5-5. Benefits of an RI Department.............................................................................................36
Figure 5-6. Factors to Consider When Setting Up an RI Department..................................................36
Figure 8-1. Sample Checklist for Clinical Searches. ..............................................................................55
Figure 8-2. Regulatory Research Data Collection/Presentation Format. ...............................................57
Figure 8-3. Sample Output of Regulatory Research. .............................................................................59