Dr. O’Neill has to date more than twenty years varied experience in pharmaceutical R&D working in both pharmaceutical companies and clinical research organizations (CROs). He joined the Clinical Quality Assurance department at Hoffmann-La Roche in 1992 where he is now responsible for the quality management oversight of external service providers used in Clinical R&D programs. During his time with Roche Dr. O’Neill has conducted more than 150 GXP qualification or in-process audits of service providers world-wide. He is certified by the internationally recognized Institute for Quality Assurance as a Principal Quality Management Systems 2000 Auditor, is a Fellow of the Royal Society of Medicine, and a member of the British Institute of Regulatory Affairs, and was also awarded a diploma in Pharmaceutical Medicine by the Swiss Association of Pharmaceutical Professionals.
Appearing:
Day 1 Stream 2: Clinical outsourcing performance management
1.25pm
Sponsor / service provider collaboration in Quality Risk Management
• Implementing collaborative and effective Quality Risk Management with our service providers
• Practical approach to quality management that will facilitate quality improvement in a cost-effective manner
Jane Clarke
