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RSSL

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email University of Reading, Whiteknights Rd, Reading, West Berkshire RG6 6LA

Preparation of Pharmaceutical Samples for Metals Analysis

There has been a lot of discussion regarding the methods of analysis for pharmaceutical products as we await the upcoming changes to both the EP and USP, relating to the analysis of metal impurities.
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News and Press Releases

Synpromics expands facilities to meet demand for revolutionary gene control technology

Edinburgh, UK, 11th September 2017 - Synpromics Ltd, the leader in gene control and synthetic promoter development, today moves to new world-class facilities at the Roslin Innovation Centre. Synpromics is expanding to meet increasing global demand for its cutting-edge gene control technology, and is the first company to move into the new custom-built centre based at the University of Edinburgh’s Easter Bush Campus.
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White Papers

Points to Consider When Developing a TMF (Trial Master File) Strategy

Phlexglobal Ltd

Many organizations are currently outsourcing clinical trial activities to one or more contract research organizations (CROs). This strategy enables companies to leverage specialized expertise and take advantage of flexible resourcing throughout the conduct of a clinical trial. Outsourcing minimizes the costs of recruiting experts, building a team and maintaining an infrastructure. However, it can also add complexity as the organization looks to meets its compliance obligations regarding clinical trial documentation. The documentation referred to in Article 15(5) of Directive 2001/20/EC as the trial master file shall consist of essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated.1 This essential study specific documentation is also known as the TMF. As organizations try to minimize their reliance on paper files, the electronic TMF (eTMF) has emerged. A current industry initiative to standardize the organization of this content is known as the TMF Reference Model. This model is helping standardization efforts across paper and electronic systems. As companies implement outsourcing strategies, CROs and sponsor organizations look for a common foundation on which to build their TMF capabilities. The following paper outlines some of the challenges organizations face when outsourcing clinical trial activities to multiple contract research organizations and a strategy to facilitate partnering and management of trial information between sponsors and CROs.
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Industry Events

12th Annual Parallel Trade

6-7 February 2018, Holiday Inn Kensington Forum, London, UK

SMi Group is proud to announce the return of Europe’s only Parallel Trade conference. Back for the 12thyear, Parallel Trade returns to London on 6th-7th February 2018.
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