Speaker Module C

David Jefferys is currently the Senior Vice President for Global Regulatory, Healthcare Policy and Corporate Affairs, Eisai Europe and Chairman of the Eisai Global Regulatory Council. He also sits as a member of the European Working Group of the UK Ministerial Industry Strategy Group and UK Innovation Board.  He is Chairman of the ABPI Regulatory Affairs Group and a member of several EFPIA committees. Also co-chairman of the IFPMA RPTS

He joined Eisai in January 2005 on retirement from the UK Civil Service. Dr Jefferys qualified in medicine in 1976 and after a career in clinical and academic medicines joined the UK Department of Health in 1984 to work on the review of medicines. He rose to become Director of the Licensing Division and an executive director of Medicines Control Agency. During this time he served as the principal assessor to the Committee on the Safety of Medicines. He was also a delegate to the CPMP from 1986 to 1994 and chaired the operations working party of the CPMP (now the CHMP). From 1995 to 2000 he was the UK delegate on the CPMP (CHMP). He chaired the Mutual Recognition Facilitation Group (MRFG) and the Pharmaceutical Evaluation Reports Scheme Committee. He was a WHO adviser. During this time Dr Jefferys was involved with ICH and joined the CMR International Regulatory Board in 1992 becoming Chairman of the Advisory Board from 2000 to 2004. He remains a member of the Board.

In February 2000 he was appointed Chief Executive Director of the Medical Devices Agency for the Department of Health. During this time he served on the Medical Device Expert Group of the European Union and on the Global Harmonisation Task Force. He was a member of the Healthcare Industry Task Force and chaired the Regulatory and Patient Safety Group of the Task Force. On the creation of the MHRA he acted as joint chief executive until April 2004, when he transferred to become special advisor in advanced healthcare technology to the Department of Health and worked on secondment with the EMEA on benefit/risk evaluation.

David Jefferys has lectured extensively in Drug and Device regulation, also on Risk Management, Benefit/Risk Evaluation and Product Development. He was a consultant to several medical device companies and remains a medical device expert adviser. He is the author of many papers and book chapters. He was given the Distinguished Service Award of DIA in 1992. He was a visiting professor in medicine at the University of Newcastle and is Chief External Examiner in Translational Medicines at Cranfield University and for the ICRI (Indian Clinical Research Institute). He is a member of the TOPRA Advisory council and was President of RAPS in 2008 chairing the RAPS Board until July 2010.He was chairman and President of TOPRA in 2012.