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Pharmaceutical Manufacturing and Packing Sourcer
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The challenges facing the clinical trials sector have never been greater: an informed public are demanding better health and quality of life; governments and international organisations continue to enhance the scope and powers of their regulatory bodies; and investors expect healthy dividends. These commercial, medical and regulatory pressures are felt by organisations involved in clinical trials across the spectrum, including the logistics providers who are increasingly valued as key partners in the trial process rather than incidental suppliers. The logistics challenge (and how to meet it) can be viewed in two ways: how current issues are impacting on the running of clinical trials from the logistics viewpoint; and how you can get the best from your logistics providers. Understanding the issues and practicalities facing logistics providers, and knowing what you should expect from them, can only promote a more efficient and successful trial. Clinical trials logistics must adapt to constantly changing times. Issues of regulation are often at the forefront. Consider for instance the influence of international transport authorities such as the International Air Transport Association, global health bodies such as the World Health Organization (WHO), and national drug approval bodies such as the Food and Drug Administration (FDA) and the Medicines and Healthcare Products Regulatory Agency (MHRA). Local customs authorities as well as the intervention of the Department of Environment, Food and Rural Affairs (DEFRA) in the UK and the US Department of Agriculture (USDA) must also be considered.
The difficulties of running clinical trials, such as subject recruitment and providing training to investigators, are also key priorities to address in order to be successful. It is clear that gaining approval for new drugs is getting much tougher; more information needs to be provided and higher standards met, whilst keeping to tight budget and time restraints.
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EMBALLAGE 2008. World Packaging Exhibition
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