Top distance clinical research courses in India | Syllabus | Intervie Top distance clinical research courses in India _ | Page 2

5. Kinds of Clinical Research
6. Periods of clinical research
7. Clinical Trials in Republic of India – The National Perspective
8. Post advertising observation
9. Pharmaceutical Industry – Global and Indian Perspective
10. Clinical Trial advertise
11. Vocation in Clinical Research
Module 2: Pharmacology and medication advancement
1. Prologue to Pharmacology
2. Idea of Essential Drugs
3. Courses of Drug Administration
4. Prologue to Drug Discovery and Development
5. Obstacles in Drug Development
6. Wellsprings of Drugs
7. Rudiments of Drug Discovery and Development
8. Ways to deal with Drug Discovery
9. Developmental Classification of the systems for Drug Discovery
10. Rising advances in Drug Discovery
11. Preclinical Testing
12. Investigational New Drug Application
13. Clinical preliminaries
14. New Drug Application and Approval
15. Pharmacokinetics
16. Pharmacodynamics
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1. Late advances – Pharmacogenomics and Protein based treatments Appendix I FDA 1571
Investigational New Drug Application Appendix II FDA 1572 Statement of Investigator
Module 3: moral concerns and Guideline in Clinical analysis
1. Authentic rules in Clinical Research
Nuremberg code Declaration of Helsinki Belmont report
2. Universal Conference on Harmonization (ICH)
Brief history of ICH Structure of ICH
ICH Harmonization Process
3. Rules for Good Clinical Practice
Glossary
The Principles of ICH GCP
Institutional Review Board/Independent Ethics Committee Investigator
Support
Clinical Trial Protocol and Protocol Amendment(S) Investigator's Brochure
Fundamental Documents for the direct of a Clinical Trial
4. Self Assessment Questions
Module 4: Regulation in Clinical Research
1. Presentation of Clinical Trial Regulation
2. European Medicine Agency
3. Nourishment and Drug Administration (US FDA)
4. Medication and corrective act
5. Timetable Y
6. ICMR Guideline
Module 5: Clinical Trial Management
1. Task Management
2. Convention in Clinical Research
3. Educated Consent