Back to Report Store Home

Risk Evaluation and Mitigation Strategy (REMS) - Opioids, Erythropoesis-Stimulating Agents and Cancer Therapeutics are the Most Important Classes That Require REMS

  • Published: May-2011
  • Report Code: GBIHC087MR
  • Report Format: pdf

Description

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

License Details
Electronic PDF copy delivered via email. Report can be used by individual purchaser only.
Single User Licence
$3500
Electronic PDF copy delivered via email. Report can be shared by unlimited users within one corporate location, e.g. a regional office.
Site Licence
$7000
Electronic PDF copy delivered via email. Report can be shared globally by unlimited users within the purchasing corporation e.g. all employees of a single company.
Global Licence
$10500
Email to a colleague Enquire Before Buying
Prefer to speak to a team member? Call us on:
+44 161 359 5414
Or click here to contact us
Secure Payments
Cards