PRLog (Press Release) –
Jun 18, 2008 – Peter Mayne, QA Manager of OSI Pharmaceuticals speaking at GTCbio’s Global Clinical Trial Operations conference on September 25-26, 2008 in San Diego, CA. Dr. Mayne will be presenting on being an EU Qualified Person (QP) as a small offshoot of a virtual company.
Since the introduction of the EU Clinical Trials Directive in 2004 it has been a requirement within Europe for investigational medicinal products to be “certified”
by a Qualified Person (QP) before they are used in a clinical study. This talk will cover the role and responsibilities of the QP from the perspective of a virtual US-based company with a single QA representative in the U.K., concentrating on how the QP puts themselves in a position to certify that all manufacturing operations are performed to standards equivalent to EU GMPs and in accordance with European regulatory submissions. The presentation will cover common US misunderestimations of the role of the QP and other potential pitfalls for companies in similar positions.
The Global Clinical Trial Operations conference brings together leaders, directors, vice presidents, heads, managers, supervisors, and CROs from all over the world to collaborate and discuss the latest developments in clinical trial operations and logistics and covers clinical trials in emerging markets, first-in-man clinical trials, pediatric clinical trials, material storage, distribution, site selection, patient recruitment and retention, technology in clinical trials and case studies of running global clinical trials.
For more information including a detailed agenda, exhibitor opportunities and registration information visit http://gtcbio.com/conferenceDetails.aspx?id=127.
