v
Figure 18-1. Due Diligence in the Acquisition of a Pharmaceutical Asset Compared to a House
Purchase ...............................................................................................................................................142
Figure 24-1. Interaction of Regulatory Intelligence and Regulatory and R&D Strategy.....................175
Tables
Table 2-1. Overview of Key Regulatory Agencies....................................................................................8
Table 3-1. Contributions by Discipline for Strategy Development. .......................................................17
Table 3-2. Example of High-Level Strategy Output. ............................................................................19
Table 5-1. Comparison of Small and Large Companies’ RI Departments. ............................................39
Table 6-1. Useful Google Search Tips....................................................................................................42
Table 7-1. Blogs of Choice. ....................................................................................................................48
Table 10-1. Submissions Under Review. ................................................................................................65
Table 10-2. Scientific Advice..................................................................................................................66
Table 10-3. Expedited Pathways and Their Designations.......................................................................67
Table 10-4. Advisory Committees/Advisory Groups. ............................................................................69
Table 10-5. Orphan Medicines. .............................................................................................................69
Table 10-6. Pediatric...............................................................................................................................70
Table 10-7. Clinical Trial Databases/Registries......................................................................................71
Table 10-8. Review Summaries and Approval Packages........................................................................72
Table 10-9. Approved Labeling..............................................................................................................75
Table 10-10. Orphan Medicines............................................................................................................76
Table 10-11. Risk Management Information.........................................................................................77
Table 10-12. Postmarketing Requirements and Commitments..............................................................77
Table 10-13. Lifecycle Information and Supplements/Variations. .........................................................78
Table 10-14. Product Data Exclusivity...................................................................................................79
Table 11-1. Clinical Trial Registries. ......................................................................................................84
Table 11-2. Cortellis Regulatory Intelligence™ and IQVIA Regulatory Intelligence: Product Features... 85
Table 11-3. PharmaPendium® Features. ................................................................................................87
Table 11-4. Features of Doctor Evidence DOC Label™ and Reed Tech Navigator™ for Drug Labels. ..87
Table 11-5. Summary of Uses of RI Databases. .....................................................................................90
Table 12-1. Location of Regulatory Guidelines for English-Speaking Countries/Regions. ..................93
Table 13-1. Regulatory Authority White Paper Examples.....................................................................99
Table 13-2. Other White Paper Resources.............................................................................................99
Table 14-1. Global FOI Sites...............................................................................................................102
Table 14-2. US FOIA Exemptions and Exclusions..............................................................................102
Table 14-3. Information Released by TGA Under FOI.......................................................................107
Table 14-4. Reasons for TGA to Refuse a FOI request or Redact information. ..................................107
Table 16-1. Profile Collection Example................................................................................................127
Table 18-1. Key Regulatory Agency Websites for Obtaining Approval Information...........................151
Figure 18-1. Due Diligence in the Acquisition of a Pharmaceutical Asset Compared to a House
Purchase ...............................................................................................................................................142
Figure 24-1. Interaction of Regulatory Intelligence and Regulatory and R&D Strategy.....................175
Tables
Table 2-1. Overview of Key Regulatory Agencies....................................................................................8
Table 3-1. Contributions by Discipline for Strategy Development. .......................................................17
Table 3-2. Example of High-Level Strategy Output. ............................................................................19
Table 5-1. Comparison of Small and Large Companies’ RI Departments. ............................................39
Table 6-1. Useful Google Search Tips....................................................................................................42
Table 7-1. Blogs of Choice. ....................................................................................................................48
Table 10-1. Submissions Under Review. ................................................................................................65
Table 10-2. Scientific Advice..................................................................................................................66
Table 10-3. Expedited Pathways and Their Designations.......................................................................67
Table 10-4. Advisory Committees/Advisory Groups. ............................................................................69
Table 10-5. Orphan Medicines. .............................................................................................................69
Table 10-6. Pediatric...............................................................................................................................70
Table 10-7. Clinical Trial Databases/Registries......................................................................................71
Table 10-8. Review Summaries and Approval Packages........................................................................72
Table 10-9. Approved Labeling..............................................................................................................75
Table 10-10. Orphan Medicines............................................................................................................76
Table 10-11. Risk Management Information.........................................................................................77
Table 10-12. Postmarketing Requirements and Commitments..............................................................77
Table 10-13. Lifecycle Information and Supplements/Variations. .........................................................78
Table 10-14. Product Data Exclusivity...................................................................................................79
Table 11-1. Clinical Trial Registries. ......................................................................................................84
Table 11-2. Cortellis Regulatory Intelligence™ and IQVIA Regulatory Intelligence: Product Features... 85
Table 11-3. PharmaPendium® Features. ................................................................................................87
Table 11-4. Features of Doctor Evidence DOC Label™ and Reed Tech Navigator™ for Drug Labels. ..87
Table 11-5. Summary of Uses of RI Databases. .....................................................................................90
Table 12-1. Location of Regulatory Guidelines for English-Speaking Countries/Regions. ..................93
Table 13-1. Regulatory Authority White Paper Examples.....................................................................99
Table 13-2. Other White Paper Resources.............................................................................................99
Table 14-1. Global FOI Sites...............................................................................................................102
Table 14-2. US FOIA Exemptions and Exclusions..............................................................................102
Table 14-3. Information Released by TGA Under FOI.......................................................................107
Table 14-4. Reasons for TGA to Refuse a FOI request or Redact information. ..................................107
Table 16-1. Profile Collection Example................................................................................................127
Table 18-1. Key Regulatory Agency Websites for Obtaining Approval Information...........................151