Robert W. Tribe

ISPE
AP Regulatory Affairs Advisor
Bob Tribe joined the Therapeutic Goods Administration (TGA), Australia in 1971 as a GMP inspector after having worked in the pharmaceutical industry in a senior Quality Assurance position. He became Chief GMP Inspector in 1980, a position he held until his retirement in 2004. While at TGA he was elected Chairman of PIC/S in 2000-2001.

After retiring from TGA he established “Bob Tribe Consulting” and has assisted many GMP regulatory authorities around the world reach the PIC/S level of regulatory control. Of the sixteen regulatory authorities that he has assisted to date, ten have obtained PIC/S membership. He also consults to pharmaceutical manufacturers wishing to achieve compliance with PIC/S GMP requirements.

Bob is a member of the WHO Expert Committee on Specifications for Pharmaceutical Preparations and undertakes GMP inspections for the WHO under its Pre-qualification Programme.

Bob is the ISPE Regulatory Affairs Advisor for the Asia-Pacific region.

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Regulatory Panel Discussion on International Collaboration and Reliance
iSpeak Blog
Regulatory Panel Discussion on International Collaboration and Reliance

On 17 August 2022, four international regulators discussed how the Covid-19 pandemic had taught regulators to look for alternative ways of doing GMP inspections and also to rely more on each other to make determinations on the GMP status of manufacturers of medicines.