Table of Contents
1 Table Of Contents
1.1 List of Tables
1.2 List of Figures
2 Risk Evaluation and Mitigation Strategies - Executive Summary
2.1 Risk Evaluation and Mitigation Strategies (REMS) to Ensure Safe Use of Opioids
2.2 REMS Elements such as ETASU have seen increased implementation in the recent past
2.3 FDA mandates REMS for Erythropoiesis-Stimulating Agents (ESAs)
3 Risk Evaluation and Mitigation Strategies - Introduction
3.1 GBI Research Report Guidance
4 Risk Evaluation and Mitigation Strategies - Drug Development and Pharmacovigilance
4.1 Drug Discovery and Development
4.1.1 Early Stage Drug Discovery
4.1.2 Phase I
4.1.3 Phase II
4.1.4 Phase III
4.1.5 Registration
4.1.6 Phase IV
4.2 Pharmacovigilance
4.2.1 Pharmacovigilance in Different Countries
4.2.2 Pharmacovigilance in Europe
4.2.3 Pharmacovigilance in the US
4.3 Post Marketing Research and Surveillance
4.3.1 Post marketing Surveillance
4.3.2 Adverse Event Reporting System (AERS)
4.3.3 Center for Drug Evaluation and Research (CDER)
4.4 Need for REMS
4.4.1 Number of Adverse Events Reports
4.4.2 Increase in healthcare costs in top seven geographies
5 Risk Evaluation and Mitigation Strategies - Overview
5.1 What are REMS?
5.1.1 RiskMAPs and REMS
5.1.2 Components of REMS
5.2 Food and Drug Administration Amendments Act (FDAAA) of 2007
5.2.1 Prescription Drug User Fee Amendments, 2007
5.2.2 Medical Device User Fee Amendments, 2007
5.2.3 Pediatric Research Equity Act, 2007
5.2.4 Best Pharmaceuticals for Children Act, 2007
5.3 Approved Risk Evaluation and Mitigation Strategies - 2008-2010
5.3.1 FDA Approved REMS, 2008
5.3.2 FDA Approved REMS, 2009
5.3.3 FDA Approved REMS, 2010
5.4 Deemed REMS Approvals
5.5 Implications of REMS
5.6 REMS by Drug Class
5.7 REMS and Generics
6 Risk Evaluation and Mitigation Strategies - Opioids
6.1 Introduction
6.2 Opioids and REMS
6.3 Case Studies - Opioids
6.3.1 Oxycodone
6.3.2 Embeda
6.3.3 Exalgo
6.3.4 Onsolis
7 Risk Evaluation and Mitigation Strategies - Erythropoiesis-Stimualting Agents
7.1 Erythropoiesis-Stimulating Agents (ESAs)
7.2 ESA Drug Profiles
7.2.1 Epogen
7.2.2 Aranesp
7.2.3 Procrit/Eprex
7.3 Risk Evaluation and Mitigation Strategies – Other Case Studies
7.3.1 Accutane (Isotretinoin) – iPLEDGE Program
7.3.2 Tysabri (Natalizumab) – TOUCH Program
7.3.3 Nplate (romiplostim) – NEXUS Program
8 Risk Evaluation and Mitigation Strategies – Opportunities in Niche Markets
8.1 REMS and Personalized Medicine
8.2 REMS and Orphan Drugs
9 Risk Evaluation and Mitigation Strategies - Electronic Record Maintenance and IT Solutions
9.1 Electronic Data Capture (EDC)
9.1.1 Cost Saving Scenario in EDC
9.1.2 Case Studies
9.2 Electronic Patient Report Outcome System (ePRO)
9.2.1 Cost Saving Scenario with eDiaries
9.3 Interactive Voice Response Systems (IVRS)
9.4 Clinical Data Management Systems (CDMS)
9.5 Information Technology in the Manufacturing & Supply Chain
9.5.1 E-Pedigree Solutions
9.5.2 Track and Trace Solutions
9.5.3 Product Callback Management
9.5.4 Sample Distribution Management
10 Risk Evaluation and Mitigation Strategies – Competitive Landscape
10.1 Inflexxion, Inc
10.1.1 Business Description
10.1.2 Snapshot
10.2 inVentiv Health
10.2.1 Business Description
10.2.2 ParagonRx
10.2.3 Snapshot
10.3 BioTrak Research
10.3.1 Business Description
10.3.2 Snapshot
10.3.3 REMS Solutions - Case Study
11 Other Major Clinical Research Organizations offering REMS services
11.1 PRA International
11.1.1 Business Description
11.1.2 Services Offered
11.2 Covance
11.2.1 Business Description
11.2.2 Services Offered
11.3 Kendle International Inc.
11.3.1 Business Overview
11.3.2 Services Offered
11.4 Pharmaceutical Product Development
11.4.1 Business Description
11.4.2 Services Offered
12 Risk Evaluation and Mitigation Strategies - The Future
13 Appendix
13.1 Market Definitions
13.2 Abbreviations
13.3 Research Methodology
13.3.1 Coverage
13.3.2 Secondary Research
13.3.3 Primary Research
13.4 Expert Panel Validation
13.5 Contact Us
13.6 Sources
13.7 Disclaimer