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.
The ISPE Global Pharmaceutical Regulatory Summit, held virtually on 28 April 2021, brought together 11 regulators from different parts of the world to discuss how their approaches to GMP inspections have adapted to the COVID-19 pandemic.
This virtual ISPE Global Pharmaceutical Regulatory Summit, held on 28 April 2021, brought together eleven regulators from different parts of the world to discuss how their approach to GMP inspections have adapted to the COVID-19 pandemic. Such a large number of regulators at a single forum is...
At the ISPE Singapore Affiliate’s 20th Anniversary Conference on 9-12 December 2020, two international regulators and a senior representative from industry discussed current and future collaboration between industry and regulatory authorities.
At the ISPE Singapore Affiliate’s 20th Anniversary Conference on 9-12 December 2020, four international regulators discussed how regulatory authorities and industry were responding to the COVID-19 pandemic crisis.
The Asia Pacific region, which comprises 24 culturally diverse countries, contains 60% of the world's population and is the fastest growing region in the world today This article describes the growing influence of Pharmaceutical Inspection Co-operation Scheme (PIC/S) in the Asia Pacific region. Of...