Author: Pavle Vukojevic, MD
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