Informed Consent Process and Procedure|pharmaceutical regulatory science|Unit 4 скачать в хорошем качестве

Informed Consent Process and Procedure|pharmaceutical regulatory science|Unit 4

Informed consent Process and procedure: Informed consent is the process in which a health care providers educates a patient about the risk, benefits and alternative of a given procedure or intervention. Portion Explained: 1. Informed consent Process and procedure 2. Requisite 3. Essential information for participants 4. Responsibility of researchers 5. Documentation of informed consent Process 6. Electronic consent 7. Specific issues in clinical trials For Other videos of Pharmaceutical Regulatory Science, Click on Links…. 1. Stages of Drug Discovery    • Stages of Drug Discovery| Pharmaceutical r...   2. Drug Development Process    • Drug Development Process| Pharmaceutical r...   3. Pre-Clinical Studies    • Pre-Clinical Studies|pharmaceutical regula...   4. Non-Clinical Activities    • Non-Clinical Activities| pharmaceutical re...   5. Clinical Studies    • Clinical Studies| pharmaceutical regulator...   6. Innovator vs Generic    • Innovator vs Generic| Pharmaceutical regul...   7. Concept of Generic    • Concept of Generic| Pharmaceutical regulat...   8. Generic Drug Products Development    • Generic Drug Products Development| Pharmac...   9. Investigational New Drug Application    • Investigational New Drug Application| INDA...   10. New Drug Application    • New Drug Application| NDA|pharmaceutical r...   11. Abbreviated New drug application    • Abbreviated New drug application|ANDA|phar...   12. Changes to an Approved NDA or ANDA    • Changes to an Approved NDA or ANDA|pharmac...   13. Regulatory Authorities of India    • Regulatory Authorities of India|Pharmaceut...   14. Overview of Regulatory Authorities of United State    • Overview of Regulatory Authorities of Unit...   15. Overview of Regulatory Authorities of European Union    • Overview of Regulatory Authorities of Euro...   16. Overview of Regulatory Authorities of Australia    • Overview of regulatory authorities of Aust...   17. Overview of Regulatory Authorities of JAPAN    • Overview of regulatory authorities of Japa...   18. Overview of Regulatory Authorities of CANADA    • Overview of regulatory authorities of Cana...   19. Type of Applications    • Type of Applications| pharmaceutical regul...   20. Procedure for export of pharmaceuticals    • Procedure for export of pharmaceutical pro...   21. Technical Documentation    • Technical Documentation|pharmaceutical reg...   22. Drug Master Files    • Drug Master Files|DMF|pharmaceutical regul...   23. Common Technical Document|CTD|    • Common Technical Document|CTD|Pharmaceutic...   24. Electronic common technical document|eCTD    • Electronic common technical document| eCTD...   25. ASEAN Common technical dossier    • ASEAN Common technical dossier|ACTD|pharma...   26. Developing of Clinical trail protocols    • Developing of Clinical trail protocols|pha...   27. Institutional Review Board    • Institutional Review Board|Independent Eth...   28. Informed Consent Process and Procedure    • Informed Consent Process and Procedure|pha...   29. GCP Obligations of Investigators    • GCP Obligations of Investigators|pharmaceu...   30. GCP obligations of sponsor    • GCP obligations of sponsor|pharmaceutical ...