Conducting Clinical Trials in Europe: An Insider's Analysis Overview

Table of Contents

CHAPTER 1: INTRODUCTION: THE CLINICAL TRIALS MARKET - A VIEW FROM EUROPE

• 1.1. Europe - A Definition
• 1.2. Clinical Trials in Europe
• 1.3. The History of Clinical Trials and their Regulation
  • The Origin of Clinical Trials
    • Clinical Trials in the 19th and 20th Centuries
  • Clinical Trials Today and ICH-GCP
• 1.4. The EMEA
  • History
  • Marketing Application and Approval Process
  • Organizational Structure
  • Other Services
  • The Future of the EMEA
• 1.5. The EU Directive
  • Content of European Clinical Trials Directive
  • Effects of Implementation of EU Clinical Trial Directive

CHAPTER 2: EMEA MEMBER STATES

• 2.1. Basic Structure of a Clinical Trial Submission within all EMEA Member States
  • EudraCT
  • Ethics Committees and Competent Authorities
  • Clinical Trial Amendments
  • Declaration of the End of a Clinical Trial
  • Import License and the Role of QP
  • Further Information
• 2.2. Austria
  • Country Description
  • Clinical Trials in Austria - A Brief Overview and History
  • Process for Conducting a Clinical Trial in Austria
  • Ethics Committees
  • Competent Authority
  • Import Licenses
  • Costs
  • FDA Inspection Results
  • Insider Tips
• 2.3. Belgium
• 2.4. Bulgaria
• 2.5. Cyprus
• 2.6. Czech Republic
• 2.7. Denmark
• 2.8. Estonia
• 2.9. Finland
• 2.10. France
• 2.11. Germany
• 2.12. Greece
• 2.13. Hungary
• 2.14. Iceland
• 2.15. Ireland
• 2.16. Italy
• 2.17. Latvia
• 2.18. Liechtenstein
• 2.19. Lithuania
• 2.20. Luxembourg
• 2.21. Malta
• 2.22. The Netherlands
• 2.23. Norway
• 2.24. Poland
• 2.25. Portugal
• 2.26. Romania
• 2.27. Slovakia
• 2.28. Slovenia
• 2.29. Spain
• 2.30. Sweden
• 2.31. United Kingdom

CHAPTER 3: NON-EMEA COUNTRIES IN EUROPEAN AREA

• 3.1. Albania
• 3.2. Bosnia
• 3.3. Croatia
• 3.4. Macedonia
• 3.5. Montenegro
• 3.6. Serbia
• 3.7. Switzerland
• 3.8. Turkey

CHAPTER 4: RUSSIA AND CIS EUROPEAN COUNTRIES

• 4.1. Russia
• 4.2. Ukraine
• 4.3. Belarus
• 4.4. Georgia
• 4.5. Moldova
• 4.6. Armenia
• 4.7. Non European CIS countries: Azerbaijan, Kazakhstan, Kyrgyzstan, Tajikistan and Uzbekistan
  • Azerbaijan (Joined CIS in 1991)
  • Kazakhstan (Joined CIS in 1991)
  • Kyrgyzstan (Joined CIS in 1991)
  • Tajikistan (Joined CIS in 1991)
  • Uzbekistan (Joined CIS in 1991)

CHAPTER 5: COMPARISON TO THE UNITED STATES

• 5.1. FDA Inspections in Europe
• FDA Inspection Outcomes
  • Comparison with EMEA Member States
  • Comparison with Non-EMEA European Countries
  • Comparison with Russia and the CIS
• FDA Inspection Detailed Findings: Site Deficiencies
  • Comparison with EMEA Member States
  • Comparison with Non-EMEA European Countries
  • Comparison with Russia and the CIS
• 5.2. Clinical Trial Submission Timelines
  • United States
  • EMEA Member States
  • Non-EMEA Countries
  • Russia and CIS

CHAPTER 6: WHAT THE FUTURE HOLDS FOR EUROPEAN TRIALS, EMERGING MARKETS IN EUROPE

• 6.1. EMEA Countries' Future
  • EU CT Directive
  • Electronic Submissions
  • Information Exchange
• 6.2. Non-EMEA Countries' Future
  • EU CT Directive and Timelines
  • Recruitment Figures
  • Costs
  • Quality
• 6.3. Russia and CIS Future
  • EU CT Directive and Timelines
  • Costs and Quality

CHAPTER 7: APPENDICES

• Appendix A: Glossary of Selected Abbreviations
• Appendix B: Glossary of Selected Terms
• Appendix C: Relevant Contact Details and Addresses including Web Links

REFERENCES

COMPANY INDEX WITH WEB ADDRESSES

Figures

• Figure 4.1. Process of Clinical Trial Approval in Russia
• Figure 4.2. Structure of the Regulatory Authorities and Ethics Committees in Ukraine
• Figure 4.3. Process for Approval of Clinical Trials in Belarus
• Figure 4.4. Process for Approval of Clinical Trials in Georgia
• Figure 5.1. Outcomes of FDA Inspections since 1994 by Region
• Figure 5.2. Detailed Findings of FDA Inspections since 1994 by Region

Tables

• Table 5.1. Clinical Trial Submission Timelines - United States
• Table 5.2. Clinical Trial Submission Timelines - EMEA Member States
• Table 5.3. Clinical Trial Submission Timelines - Non-EMEA Countries
• Table 5.4. Clinical Trial Submission Timelines - Russia and CIS