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Table Of Contents

1.0 Politics and Economics
1.01 Background
1.02 The Economic Situation
1.03 Risks
1.03.1 Political
1.03.2 Security
1.03.3 Legal
1.03.31 Intellectual Property Rights
1.03.4 Foreign Direct Investments
1.04 Demographics
1.05 Infrastructure
1.05.1 Transportation
1.05.2 Communication
2.0 Pharmaceutical Market
2.01 History
2.03 VAT on Medicines
2.04 Market Segmentation
2.05 Market Drivers & Restrainers
2.06 Pharmaceutical Regulation
2.07 Drug Registration
2.07.1 Documents Requirements for Registration of Foreign Drugs
2.08 Certification Requirements
2.09 Pharmaceutical Promotion and Advertising
2.10 GMP
3.0 Healthcare in Russia
3.01 Healthcare Policy
3.02 Healthcare Spending
3.03.13 Polyclinics
3.03.2 Hospitals
3.03.3 Health Institutions
3.03.4 Sanatoriums and Health Resorts
3.04 Health of the Nation
3.04.1 Population Demographics
3.04.2 Life Expectancy and Causes of Death
3.05 Disease Prevalence
3.05.01 Cardiovascular Disease
3.05.02 Cancer
3.05.03 Tuberculosis
3.05.04 Diabetes
3.05.05 Drug Addiction and Alcoholism
3.04.06 Mental Disorders
3.04.07 Sexually Transmitted Disease (STD)
3.04.08 HIV
3.04.09 Dermatologic Diseases
3.04.10 Injuries, Poisoning and Other Accidents
3.04.11 Hepatitis
4.0 Clinical Trials in Perspective
4.01 History of Clinical Trials in Russia
4.02 Growth in Trials
4.03 The Russian CRO Industry
4.04 Why Conduct Clinical Trials in Russia?
4.04.01 Benefits of the Post-Soviet System
4.04.02 Access to Investigators
4.04.03 Cost Saving Opportunities
4.04.04 Access to Patients
4.04.05 Fast Recruitment Rates
4.04.06 Patient Compliance
4.04.07 Quality of Work
5.0 Clinical Trial Issues
5.01 Study Costs
5.01.1 Investigator’s Fees
5.01.2 Equipment Expenses
5.01.3 Monitoring Expenses
5.02 Language
5.03 Logistics
5.03.1 Travel
5.03.2 Mail and Courier Services
5.03.3 Communication
5.04 Background Therapy
5.05 Cultural Differences
5.06 Recruitment Issues
5.07 Logistics and Local Support
5.08 Monitoring
5.09 Data Management
6.0 Study Set-Up
6.1 Regulatory Compliance - the Federal Drug Law
6.2 Selection of a CRO and External Vendors
6.3 Site Identification/ Investigator Selection
6.31 Medical Institutions
6.4 Local IECs
6.5 Protocol and CRF Design
6.51 Protocol
6.52 CRF
6.6 Legal Issues, Insurance and Contracts
6.61 Patient Information and Informed Consent Form
6.62 List of Documents to be Submitted to Local IRB/IEC or Regulatory Authority
6.63 Local Insurance Policy
6.64Contracts with Investigators and Investigative Sites
6.7 Study Approval
6.8 Patient Recruitment
6.9 Site Training
7.0 Importing Clinical Trial Materials
7.10 Importing the Study Drug
7.10.1 A Centralised Approach
7.20 Importing Other Materials
7.20.1 Study Documents
7.20.2 Devices
7.20.3 Laboratory Kits
7.20.4 Packing Materials
7.30 Exportation of Biological Media
7.40 Export of Other Clinical Trial Materials
7.50 Summary
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Clinical Trials Russia

Clinical Trials Russia

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Published by arimanok

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Published by: arimanok on Aug 29, 2010
Copyright:Attribution Non-commercial

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05/19/2012

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