Home > COURSES > 40 Days Intensive training on ICH-GCP,DigVijaya-Hyderabad

40 Days Intensive training on ICH-GCP,DigVijaya-Hyderabad

Course Contents:
1. Overview of CRO Industry in India
2. Clinical Research Terminology
3. Medical Terminology
4. Introduction to Clinical Research
5. Phases of Drug Development
6. Evolution of Ethics in Bio-Medical Research
7. Ethics


8. Informed Consent
9. protocol
10. Investigator Brochure (IB)
11. Case Report Form-I
12. Forms and logs
13. e-CRF
14. Monitoring Responsibilities
15. Responsibilities of Investigator
16. Pharma co Vigilance-I
17. IND 21 CFR.312
18. Sponsor Responsibilities
19. Data Management
20. Fraud in Clinical Research
21. Responsibilities of CRA
22. Preparations of Study Reports
23. Scheduled ‘Y’
24. IVRS & Conflict of Interest
25. Project Management
26. ICH-GCp Guidelines.
27. FDA Guidelines
Eligibility: B.Pharmacy/M.Pharmacy/M.Sc (Life sciences), MBBS, M.D
No. of days: 40days (80 hrs) Timings: 6-8 P.M & 7-9 A.M
For Details contact:
DIGVIJAYA MANAGEMENT CONSULTANTS PVT.LTD.
4D, 4th Floor, Nandanavanam Complex,
S.R.Nagar, HYDERABAD-38
Ph: 23817576, Mobile: +91-9348914666
http://www.digvijaya.com
Email:ichgcp@gmail.com

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