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European Pharmaceutical Contractor

Qualified Matters

Clinical trials are conducted in research settings, designed to answer specific questions about biomedical or behavioural interventions, including new treatments – such as novel vaccines, drugs, dietary choices and supplements and medical devices – as well as known interventions that warrant further study and comparison. They generate critical data on safety and efficacy, which is then submitted to the regulatory authorities responsible for vetting the risk versus benefit ratio of the trial.

As the demand for new therapies and treatments persists, the need for clinical studies expands globally. This comes with a growing need for organisations to ensure they are able to design, start up and execute their trials, thus delivering critical information regarding the results.

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Marquard Lett is Senior Advisor at UL Compliance to Performance and has over 38 years’ experience in highly regulated industries, including the pharma industry in manufacturing, training and qualification systems, training quality systems and business and manufacturing process improvement.

Gordon Elger
is Senior Advisor at UL Compliance to Performance and has more than 30 years’ experience in the pharma industry in R&D, manufacturing, regulatory affairs, compliance and document management. He has been responsible for regulatory submissions and liaison with agencies at scientific advice meetings, leading the design and implementation of document management systems and is fully conversant with GxP requirements. Email: gordon.elger@ul.com
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Marquard Lett
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Gordon Elger
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White Papers

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Many sponsor organizations have already recognized the value of moving from paper to electronic Trial Master Files (eTMFs). But few sponsors have taken a more holistic approach to the TMF lifecycle and looked at the entire process from study start-up through archiving of the TMF in electronic format, also known as e-archiving. The recurring value of managing, tracking, maintaining and accessing electronic files should not stop at the point of archiving. All of the challenges of managing an active paper TMF carry through to a paper archive. All of the benefits of an electronic TMF also carry through to the electronic archive. As companies look to move their compliance assets to secure, long-term storage, it is important to consider ongoing compliance requirements, security, accessibility, efficiency and costs of archiving TMF content in a digital format.
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Pharmapack Europe 2018

7-8 February 2018, Hall 7.1, Paris Expo, Porte de Versailles, Paris.

As Europe's dedicated Pharmaceutical Packaging and Drug Delivery event, Pharmapack is the industry's go-to place to kick-off the year.
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