10. Roadmap of the Submission Process of a Clinical Trial

9. Subject Considerations

2. General Questions

6. Biological Specimen

3. Ethics Committee (EC)/Institutional Review Board (IRB)

5. Investigator and Investigational Product

4. Regulatory Authority (RA)/Competent Authority (CA)

8. Data Management

7. Remote Monitoring

1. Executive Summary

11. Regulatory Overview - DCT Components

Overview of Sustainability Requirements for Packaging

Overview of Packaging Legislation in Spain

8. Safety Parameters

7. Importation Requirements

9. Advertising Aspects

9. Advertising Aspects

8. Safety Parameters

6. Registration Processes

5. Claim Requirements