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European Society for Medical Oncology (ESMO)

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The current and future role of the medical oncologist in the professional care for cancer patients: a position paper by the European Society for Medical Oncology

 

The number of cancer patients in Europe is rising and significant advances in basic and applied cancer research are making the provision of optimal care more challenging. The concept of cancer as a systemic, highly heterogeneous and complex disease has increased the awareness that quality cancer care should be provided by a multidisciplinary team (MDT) of highly qualified healthcare professionals. Cancer patients also have the right to benefit from medical progress by receiving optimal treatment from adequately trained and highly skilled medical professionals. Built on the highest standards of professional training and continuing medical education, medical oncology is recognised as an independent medical specialty in many European countries.

The current and future role of the medical oncologist in the professional care for cancer patients: a position paper by the European Society for Medical Oncology
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News and Press Releases

MedPharm announce expansion of partnership with Palvella Therapeutics in developing a new treatment for the debilitating rare disease, pachyonychia congenita

MedPharm Ltd have announced the expansion of their partnership with Palvella Therapeutics, Inc., a Philadelphia-based biopharmaceutical company focused on developing and commercialising therapies for debilitating, rare genetic diseases. To date, MedPharm has employed its world-renowned specialist formulation expertise to support Palvella’s development of a novel, high-strength rapamycin topical formulation for application to the skin (PTX 022) as a disease-modifying treatment for pachyonychia congenita (PC). Most recently, MedPharm has made arrangements to manufacture the clinical (IMP) batches for use in Palvella’s upcoming Phase 2/3 clinical study.
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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

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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