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Pharmaceutical Manufacturing & Packaging Congress (PHARMAP 2022)

20-21 June 2022, Berlin, Germany

Pharmaceutical Manufacturing & Packaging Congress (PHARMAP 2022) is held on June, 20-21, 2022 in Berlin, Germany. The Congress gathers pharmaceutical companies, CMOs and CDMOs, governmental bodies together with pharmaceutical equipment providers and service companies to discuss the manufacturing and packaging processes of the pharmaceutical industry. Among the participating companies are Bayer, Sandoz, Merck, Novartis, Roche, Genveon, Samsung Biologics, Pfizer.
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News and Press Releases

eTheRNA Manufacturing Announces New LNP Formulation Development and Production Service

NIEL, BELGIUM, March 28, 2022, eTheRNA Manufacturing, a specialist RNA process developer and manufacturing member of the Belgian eTheRNA group, is introducing a new Lipid Nanoparticle (LNP) formulation development and production service to support the discovery and early pre-clinical development of RNA-based therapeutics and vaccines.
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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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