Robert W Tribe

Regulatory Affairs Advisor, Asia Pacific ISPE

Robert Tribe has been a GMP Consultant to regulatory authorities since August 2004. He retired from the Therapeutic Goods Administration (TGA), Australia in July 2004 after holding the position of Chief GMP Auditor at TGA for 24 years. He joined the TGA in 1971 as a GMP inspector, after working in the pharmaceutical industry for six years in a Quality Assurance position.

He was the recipient of the 1999 Australia Day Achievement medallion for contributing to the successful negotiation of the MRA (mutual recognition agreement) for medicinal products between Australia and European Union. In 2004 he was the recipient of the FDA Commissioner's special citation Award as a member of the ICH Q7A Expert Working Group ("for outstanding cooperation and achievement in developing internationally harmonised good manufacturing practice guidance for active pharmaceutical ingredients used in human drug products"). In 2005 he was the recipient of the John Martin Memorial Award issued by the NSW Pharmaceutical Science Group of The Royal
Australian Chemical Institute ("For exceptional leadership and service to the Australian Pharmaceutical industry").

He has been involved with PIC/S since 1986 and was Deputy Chairman of PIC/S during 1998-1999 and the Chairman of PIC/S during 2000-2001. He currently consults to regulatory authorities around the world providing advice on their readiness for PIC/S membership, as well as conducting GMP training for the GMP inspectors and industry personnel in those countries. He also provides GMP consultancy to manufacturers of medicines.

He is currently a member of the WHO Expert Committee on Specifications for Pharmaceutical Preparations and was Rapporteur for the Committee in 2001 and 2004. He also participates as an expert GMP inspector under the WHO prequalification programme.

He became ISPE's Asia-Pacific Regulatory Affairs Advisor in July 2004. Robert will be the moderator for the Leadership Forum on Tuesday, 15 September, 2009