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Newsletter no. 2 - August 2018

WHAT'S NEW

Save the date! XI Foresight Training Course in Pavia

On October 25-27, 2018 Pavia (Italy) will host the XI Foresight Training Course “Change in Regulatory Sciences in the EU – How to move from a reactive to a multi-stakeholders proactive attitude”. This edition is focused on the challenge to align scientific and patients’ objectives with regulatory requirements along the whole developmental process of health products. Key opinion leaders and experts coming from all over Europe will tackle three main topics: health data supporting medicines and healthcare development, also in the light of the GDPR; the new era of medical devices in Europe; rare diseases and Orphan Medical Product Regulation.
Download and fill in the registration form. If you register 
by August 31, you will receive a special discount on the registration fee!
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SIAR conference on patients' active involvement (Rome, July 10)

How the role of patients in the new therapies generation processes is conceived and where and when their contribution is needed? These were the main topics of the conference organized by SIAR (Italian Society of Regulatory Activities), in collaboration with Fondazione Gianni Benzi and Cittadinanzattiva scheduled in Rome last July 10. After a contribution in the opening session, Prof. Adriana Ceci moderated the morning roundtable on patients involvement in the different phases of the generation process of a new therapy.
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Clinical and regulatory aspects of the development
of paediatric medicines

Childern are commonly considered therapeutic orfans because most of the marketed medicines are not approved for paediatric use or thety have not been studied in paediatric population. Thus, off-label medicines and drugs formulations for adults are used, with the possible consequences related to the ineffectiveness and increase of adverse reactions. Starting from this point, Viviana Giannuzzi, head of the Research Department and coordinator of the Scientific Committee of Fondazione Gianni Benzi, had a speech at the 58th AFI Symposium in Rimini, last June 8. 
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PROJECTS UPDATES

Launch of the C4C Project

The members of the c4c initiative annouced the start of a large collaborative paediatric network that will facilitate the development of new drugs and other therapies for the entire paediatric population in Europe. The consortium aims to enhance the competitiveness of Europe as a critical region for developing medicines for children by using existing expertise, patient access and developing common processes to be applied to disease natural history studies, registries, studies of new therapies and comparisons of existing therapies.
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FGB ALERTS

Fondazione Gianni Benzi
is hiring!

Presented the 4th MonitoRare report

Fondazione Gianni Benzi is looking for new full time people to be included in its staff. Check out our official website, in the Vacancies section, for more information on skills required and activity areas!

Last July 19, the 4th edition of MonitoRare report was presented by Federazione Italiana Malattie Rare. The document presents a detailed overview of the rare disease patients condition in Italy.
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