Pharmacovigilance Training

Guidelines

1. International Conference on Harmonisation (ICH) of Technical Requirements for the Registration of Pharmaceuticals for Human Use.

Clinical Safety Data Management: Definitions and Standards for Expedited Reporting [E2A]

Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports [E2B(R3)]

Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs [E2C(R1)]

Pharmacovigilance Planning [E2E]

Good Clinical Practice [E6(R1)]

2. Council for International Organisations of Medical Sciences

3. National Pharmacovigilance Protocol [India]

4. Pharmacovigilance [Wikipedia]

5. WHO India

6. Importance of Pharmacovigilance: safety monitoring of medicinal products - WHO [PDF]

7. Good Pharmacovigilance Practices and Pharmacoepidemiological assessment - FDA Guidance to Industry

 

 

 

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Contact Address: Department of Pharmacology, Government Medical College, Amritsar, Punjab. India 143001

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Updated on: Wednesday, 8 August, 2007

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