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As clinical trials move more and more into the community, the planning and delivery of a patient centric approach is becoming more important than ever. As the industry moves towards these models, how can we ensure that the trials still meet with regulatory requirements, both from a GxP, GCP and a country specific MOH/DOH perspective?

Understanding the local legislation surrounding home healthcare provision is a key component to planning your trial, for instance, can homecare nurses administer your product unsupervised in a patient’s home? Equally, understanding local pharmacy, importation and distribution regulations has to be factored into your country selection and timeline planning.

In this webinar, World Courier and Medical Research Network will guide you through the key regulatory considerations when planning direct to patient trials, as well as providing practical examples to ensure that the quality of your trial delivery is maintained.

Paul Bodfish
Paul Bodfish
Vice President, Corporate Services
Medical Research Network Limited

Paul is responsible for the oversight, maintenance and development of MRN’s Quality Management System. A key component of this is to ensure that MRN project teams understand the potential regulatory and legal hurdles that homecare in global clinical trials brings, and how these can be mitigated and resolved. Paul is one of the original founders of MRN in 2006 and also currently has responsibility for the Training and Contracts & Proposals teams. Paul has over 20 years’ experience in clinical trials having previously spent 12 years at PAREXEL in addition to working for Proctor & Gamble and the Imperial Cancer Research Fund.

Michael Sweeney
Michael Sweeney
Senior Director, Global Service Development
World Courier Management Inc.

Mike is responsible for the development and standardization of World Courier’s services across 50+ countries, with specific focus on offerings such as direct-to-patient and cell and gene therapy. Since joining World Courier in 1992, Mike assumed a number of positions within US operations, customer service, compliance and clinical trials. He progressed to senior roles, including director of US customer service/operations, director of new service development and director of regional accounts prior to transitioning into a global IT leadership position and into his current role in mid-2015.

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