COURSE CONTENT :

1. Current Challenges in Drug Development

2. History of GCP includes ICH, GCP, E6 Guidelines

3. Clinical Trials Overview

4. Ethics Committees

5. Sponsor & Investigators

6. Clinical Data Management

7. Pharmacoepidemiology

8. Risk and Signal Management

9. Med DRA

10. ADR Defination, Clarification, Causality Assessment, Seriousness Assessment

11. What is PV, ADR Reporting

12. Tools in PV

13. Labeling BPI, IB, EMEA

14. CT CAE Guidelines

15. Safety Data Generation, Preclinical, Clinical, PMS

16. ICH Guidelines for ICSR, PSVR
a) Details of ICSR
b) Details of PSVR

 

Eligibility: B.Pharmacy / M.Pharmacy / B.Sc / M.Sc (Life sciences), B.H.M.S, M.H.M.S, Ph.D

No. of Days: 30 - 40 days

For Details Contact :

DIGVIJAYA MANAGEMENT CONSULTANTS PVT LTD.
Flat No.207, A-Block, Prabhath's Signature,
Near Kalamandir, HMT Satavahana Road,
KPHB, Hyderabad - 500 072
Ph: 040-40064942, Mobile: +91-9348914666, +91-8121752466
Email: training@digvijaya.com
URL: www.digvijaya.com