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Geoff’s has over 40 years clinical research experience, starting as a CRA long before GCP was invented. For 15 years Geoff held Clinical Operations roles for Ciba-Geigy and Warner Lambert Parke-Davis. He then spent 10 years with PPD’s Quality Management group, including the interesting time of global change brought about by the original ICH GCP guideline. With PPD he performed multiple site and vendor audits across Europe and beyond, working on projects with many of the largest pharma companies. In 2003 he moved back “in-house”, first with Novartis and then, for the past 13 years, with Eisai as Director, Clinical Quality Assurance. In this role he manages all CQA activities across Europe, with additional interests in India and the Asia-Pacific region. He has introduced risk based concepts to the QA group, manages Quality Agreements with Eisai’s CRO partners and works closely with the Processes and Standards group in developing and maintaining procedural documents. He has facilitated multiple sponsor and investigator site regulatory authority inspections. He is currently working to prepare for yet another sponsor inspection and to implement the new requirements of ICH GCP(R2) and its concepts for quality management systems across Eisai.