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These presentation papers are provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates. The papers are not legislative in nature and should not be taken to be statements of any law or policy in any way.
The Australian Government Department of Health (of which the TGA is a part) advises that (a) the presentation papers should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the presentation paper.
Presentation
- Presented by: Shabnam Sharan
- Presented at: International Society of Pharamacovigilance (ISoP) Annual Meeting 2021 – Post conference course III
- Presentation date: Thursday 18 November 2021
- Presentation summary: ICH-E2C(R2) guideline and PBRER template: concept, principles and regulators’ expectations.
Supporting documents
Presentation: ICH-E2C(R2) guideline and PBRER template
[PDF, 406.33 KB]