Advanced Program in Pharmacovigilance and Regulatory Affairs

Advanced Program in <strong>Pharmacovigilance and Regulatory Affairs</strong>

Bangalore (1st Jan)

Filling Fast

Percentage Of Seats Remaining:
62

8 Weeks 60 Hrs Placement Support

Course Brief

Advanced Program in Pharmacovigilance and Regulatory Affairs

Duration: 3 Months

A. Regulatory Affairs Module:

  1. Regulatory Affairs Background: Introduction
  2. History of Regulatory Affairs
  3. Over view of Drug Development Procedures and Clinical Research
  4. Regulatory Filing Procedures in India
  5. Regulatory Filling Procedures in US
  6. Regulatory Filling Procedures In Europe
  7. Regulatory Filling Procedures For UK
  8. Marketing Authorization Application (MAA)
  9. Regulatory Filling Procedures For Canada
  10. Regulatory Filling Procedures For Australia
  11. Regulatory Procedures For Japan
  12. Submission of Global Documents
  13. Chemistry Manufacturing Control
  14. Global Harmonization Task Force (GHTF)/ International Medical Device Regulators Forum (IMDRF)
  15. Health Care Industry Intellectual Property Rights (IPR), Patents, Copyrights and Trademarks

 

B. Pharmacovigilance Module:

 
1. Introduction to Pharmacovigilance
2. Introduction to Adverse events
3. Regulatory guidelines and laws governing Pharmacovigilance
4. Adverse event reporting method
5. Pharmacovigilance in India
6. Individual Case safety Report Processing
7. Specific events scenarios
8. Narrative writing
9. Coding with MedDra
10. Expedited reporting
         a) Expedited reporting for clinical trials drugs
         b) Expedited reporting for post marketed drugs
11. Periodic safety updates reporting
12. Case Assessment
13. Pharmacovigilance Compliance
14. Qualified person for Pharmacovigilance
15. Safety data privacy and sharing

 

“I chose to study the Advanced Program in Regulatory Affairs at CLINI INDIA due to the program flexibility. I was able to tailor my coursework around my full-time job. I chose the regulatory affairs program because this program has the reputation as being one of the best. And as a recent graduate, I would back that statement.”

C.Janardhan, Accenture, Drug Safety, Bangalore

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