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International Collaboration and Reliance: Regulatory Panel Discussion at the 2022 ISPE Singapore Conference

ISPE

It was usual practice for TGA to prepare additional guidance/explanatory documents for industry and for TGA inspection staff to participate in training seminars to assist industry. The outcomes of these inspections were shared extensively with MRA partners such as EMA and US FDA. Canada DHPID ). Canada DHPID ).

FDA 97
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Regulatory Panel Discussion on International Collaboration and Reliance

ISPE

It was usual practice for TGA to prepare additional guidance/explanatory documents for industry and for TGA inspection staff to participate in training seminars to assist industry. The outcomes of these inspections were shared extensively with MRA partners such as EMA and US FDA. The approach by TGA and HSA were very similar.

FDA 52