0930-1030

Registration & Light Morning Tea

WORKSHOP 1

Regatta D

WORKSHOP 2

Regatta B

WORKSHOP 3

Regatta C

1030-1200

Developing a Quality Management System

Having a quality management system (QMS) facilitates good quality and efficient working practices, as well as promoting continuous improvement. This workshop aims to provide:

·    An overview of the current standards and guidelines for QMS

·    An understanding of the practical elements when developing a QMS 

·    A peek in to the future of a possible GCP specific QMS

·    How to leverage the value of a QMS for your clinical research business

Zoe Breeze, Vendor Manager/Quality Manager (GCP/GVP), Roche Products NZ Limited, Auckland, NZ

Dominic Bailey, Chief Executive Office, Genesis Research Services, Broadmeadow, NSW, Australia

Interpretation of GCP for Sites & GCP Updates

This workshop is about relating GCP to real life situations. You will have an opportunity to review case studies where GCP was used to guide resolution and to ask any questions you have about interpretation of GCP.

Philippa Brydon, Principal CRA, Clinical Management, PPD, Wellington, NZ

Jan Gaskin, Director, Site Management Delivery, Country Head, New Zealand, Resourcing Lead Australia & NZ, QuintilesIMS, Auckland, NZ

Budgets, Payments and Fair Market Value

Ideal for those involved with clinical research financial activities, applicable to site, CRO and Pharma. The focus will be on discussing current processes and practices, sharing common challenges & areas for improvement, and identifying potential quick fixes and long term improvements. Attendees will complete and return a questionnaire prior to the meeting, to provide a baseline for discussion.

Stuart Ryan, Medical and Clinical Manager, Roche NZ, Auckland, NZ

Sophie Goodger, Research Team Leader - Haematology, Cancer and Blood Research, Auckland Regional Cancer and Blood Service, Auckland, NZ

Kerin Thompson, Senior Study Start-Up Associate, ICON Clinical Research (New Zealand) Ltd, Nelson, NZ