Chris James
Acting Group Manager, Medsafe, Ministry of Health, Wellington, NZ
Chris graduated from the University of Otago in 1996 with a Bachelor of Pharmacy. In 2005 he completed a Post Graduate Certificate in Clinical Pharmacy in the UK, before returning to Otago University in 2009 to complete a Post Graduate Diploma in Public Health.

Chris has just over ten years experience working as a clinical pharmacist in hospitals in New Zealand and the UK. During that time he specialised in Paediatrics and Neonatology.

In 2006 Chris joined Medsafe, assessing the pharmaceutical chemistry of new medicines before moving into post market vigilance. As part of this move Chris was editor of Medsafe's bulletin Prescriber Update for a number of years, before becoming Manager of the Clinical Risk Branch in 2011.

Chris is currently acting Group Manager of Medsafe.



Therapeutic Products Regulations

The Government is currently developing a new domestic therapeutic products regulatory regime following the cessation of the joint ANZTPA project with Australia. As well as replacing and modernising the regulatory arrangements for medicines, the regime will cover all therapeutic products including medical devices and cell and tissue therapies, which are currently not fully regulated in New Zealand. The Government has already made a series of decisions about the new regulatory regime that were made publicly available in April 2016. Work is now focused on writing a draft Therapeutic Products Bill to replace the Medicines Act 1981 and on developing the next level of detail that will sit beneath the Bill. The presentation will explain the key elements of the regime as agreed in the documents released by Government, focusing on areas of interest such as clinical trials. It will also provide an update on progress and set out the steps in the process to develop and implement the regime.