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PPMA Group Industry Awards 2019

PPMA Group is today issuing a ‘Final Call for Entries’ to the 2019 PPMA Group Industry Awards. All companies within the packaging and processing sector are invited to submit their FREE submission by the deadline of 17 July 2019.
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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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FlyPharma Europe

22-23 October 2019, Copenhagen, Denmark

The FlyPharma Conference Europe 2019 is aimed at forward-thinking individuals and businesses that are ready to uncover the potential in their pharma supply chain. The event offers an interactive platform to discuss current and future challenges within pharma and cargo, with topics including market trends, cold chain innovations, latest regulatory demands, security technology, and how to encourage collaboration between supply chain players. There will be plenty of networking opportunities, including a complimentary evening networking event, where delegates can meet and catch up with senior and executive pharma and cargo professionals – gaining strong, new industry contacts and building on existing ones.
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