Bob Tribe, ISPE Asia-Pacific Regulatory Advisor, Retires

Bob came to ISPE in 2004, furthering an already distinguished career in the pharmaceutical industry and as a regulator. After having worked in industry as a senior Quality Assurance position he joined the Therapeutic Goods Administration (TGA), Australia in 1971 as a GMP inspector. He became Chief GMP Inspector in 1980 where he influenced many of the GMP requirements. While at TGA Bob also served as Deputy Chairman of PIC/S during 1998-1999, followed by a tenure as Chairman of PIC/S from 2000-2001.

After retiring from TGA Bob remained an active consultant, guiding many GMP regulatory authorities around the world reach the PIC/S level of regulatory control. He assisted the health authorities of South Africa, Israel, Cyprus, Ukraine, Indonesia, Taiwan, South Korea, Hong Kong, Japan, Thailand, Turkey, and Iran in obtaining PIC/S membership. Most recently he assisted the regulatory authorities of Saudi Arabia, Russia, China, Jordan, and Philippines in the process to attain PIC/S membership. Bob also initiated an agreement under which ISPE’s Guidance Documents are made available to PIC/S and WHO inspectors, which is still in place today.

In his role as ISPE’s Asia-Pacific Regulatory Advisor Bob was instrumental in helping ISPE establish a presence and increase membership in the Asia-Pacific region, and well as introducing regional health authorities to ISPE. During the ISPE Malaysia Affiliate’s ten year anniversary celebration in October 2022, Dato’ Eisah Binti Rahman, one of the affiliate’s Founding Directors and former Director of Malaysia’s National Pharmaceutical Regulatory Agency (NPRA), noted Bob’s significant contribution in inspiring Malaysia’s regulatory agency on their PIC/s accession and the inception of the ISPE Malaysia Affiliate as a venue for knowledge sharing in the pharmaceutical industry.

Over the years Bob became an invaluable resource to many ISPE members. “Bob played a crucial role in my comprehensive understanding of GMP and GMP inspection,” said member Pierre Winnepenninckx. “He is always approachable and willingly shares his knowledge and expertise with passion. Bob is the true definition of a mentor, not only does he stay updated on the latest regulatory developments, but he is also leading the GMP development and ensuring correct understanding of their intent. He is always willing to help and is truly passionate about the well-being of patients.”

ISPE Singapore Affiliate chair, Shanshan Liu, remembers Bob as being instrumental in bringing compliance and inspection standards in the APAC region and other emerging regions to the global level. Ms. Liu noted that even after Bob had retired from TGA, he never stopped engaging in technical discussions and connecting with latest regulatory updates. “Bob has always been genuinely appreciating and respecting all different perspectives and proposals in the discussion, and contributing from his in-depth knowledge, solid regulatory background and acute awareness of global political environment,” she said, “Personally, Bob, as one of the most influencing mentors to me, has significantly shaped my perceptions and deepened my understanding of the industry, specifically in the regulatory domain.”

Vivien Santillan, ISPE Philippines Affiliate Vice President, concurred adding “I have personally witnessed his dedication in his field as he has also assisted the Philippines and unselfishly shared his knowledge and expertise with the industry and the FDA. Bob has a gentle persona that endears him to his contacts, but his meekness should not be mistaken as weakness as this is a trait that makes him excel in his craft.”

In addition to serving as Asia-Pacific Regulatory Affairs Advisor, Bob has written articles for ISPE’s Pharmaceutical Engineering® magazine and Ispeak® blog, moderated many regulatory discussion panels a ISPE conferences and digital event, and presented ISPE’s GMP training.

In 2004 Bob was the recipient of the US Food and Drug Administration (FDA) Commissioner’s Special Citation Award as a member of the ICH Q7A Expert Working Group, awarded for outstanding cooperation and achievement in developing an internationally harmonized GMP guidance for APIs used in human drug products. In 2005 he was the recipient of the John Martin Memorial Award for exceptional leadership and service to the Australian Pharmaceutical industry issued by the NSW Pharmaceutical Science Group of The Royal Australian Chemical Institute. ISPE presented Bob with the Joseph X. Phillips Professional Achievement Award in 2017, an award that honors an ISPE Member’s significant lifetime contribution to the industry, not just ISPE.

ISPE is grateful for all Bob has done for the Society and wishes him all the best in his next endeavors.

View the Full Series of Regulatory Digest

• Bob Tribe, ISPE Asia-Pacific Regulatory Advisor, Retires
• ISPE’s Regulatory Commenting Process
• ISPE Launches Enabling Global Pharma Innovation: Delivering for Patients
• Regulatory Panel Discussions: Annex 1 Implementation from the Regulators’ Point of View