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Newsletter no. 5 - August 2019


XII Foresight Training Course
Innovative medicine and research: ethical, legal and regulatory issues Toulouse (France), 27 September 2019

Next 27 September Fondazione Gianni Benzi organises the XII Foresight Training Course
"Innovative medicine and research: ethical, legal and regulatory issues" in Toulouse (France). This course is part of the 7th EAHL Conference "Innovation & Healthcare - New challenges for Europe", organised under the patronage of the Council of Europe. The XII Foresight Training Course will deal with legal, ethical and regulatory issues of innovation in medicine and healthcare, including advanced therapies, machine learning managing health data, access policies, translational research and vulnerable populations.
Read more - Download the speakers' list

Fondazione Gianni Benzi comments to the Discussion paper on the use of patient disease registries for regulatory purposes

Fondazione Gianni Benzi participated in the EMA consultation on methodological and operational considerations in the use of patient disease registries for regulatory purposes.The main objective of this initiative is to facilitate the use of patient registries to support regulatory decision-making.
The paper has been published to seek comments and suggestions from all the interested parties and Fondazione Gianni Benzi took the opportunity to participate in this consultation.

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Fondazione Gianni Benzi is partner of the new BIOMIS Project

Last 3 July the BIOMIS project has been officially launched in Bari. BIOMIS - Costituzione della biobanca del microbiota intestinale e salivare umano: dalla disbiosi alla simbiosi is a 3 year collaborative project aimed at establishing the first Italian biobank of intestinal, salivary and vaginal microbiota. Fondazione Gianni Benzi will be responsible for the Project Management, will grant the compliance of project activities with regulatory and ethical standards and will support the adhesion of the new BIOMIS biobank to the European research infrastructure for biobanking BBMRI - ERIC. 

Fondazione Gianni Benzi is searching for a Junior Project Manager

In order to strenghten its Project Management Team, Fondazione Gianni Benzi is looking for a Junior Project Manager. The ideal profile is an enthusiastic, proactive, professional, team work oriented and results driven person with a good knowledge of ICT process engineering activities, good knowledge of the main project management techniques, excellent knowledge of English, knowledge of IT tools such as MSProject, good organizational and managerial skills and degree in technical-scientific subjects.


EJP-RD is recruiting an Ethics Advisor

The European Joint Programme on Rare Disease is looking for an Ethics Advisor in charge of verifing the application of EU ethical/legal/regulatory provisions within the project, as well as the projects that will be financed by the EJP RD. The Ethics Advisor will closely work with the project Advisory Regulatory and Ethical Board (AREB) and the regulatory and ethical WP team that is coordinated by Fondazione Gianni Benzi. Deadline for application: 1 September 2019
Read more - Apply to the call for expression of interest

EPTRI survey on oral formulation

The EPTRI Project developed a survey using country and age-adapted questions to quantify children's experience with taking various pharmaceutical formulations.
The survey is addressed to boys and girls up to 18 years of age and can be completed with the help of an adult.


Save the date! 7th EAHL Conference
Toulouse (France), 25-27 September 2019

The Benzi Foundation is partner of the 7th EAHL Conference "Innovation & Healthcare - New challenges for Europe", that will be held in Toulouse on 25-27 September. In this framework, the Foundation organises the workshop "Innovative medicine and research: ethical, legal and regulatory issues"
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Rare diseases situation in Italy: published the new MonitoRare report

Last 3 July  in Rome the Italian Federation of Rare Disease Uniamo Fimr presented the 5th edition of the MonitoRare report, a detailed overview of the rare disease patients condition in Italy.
The report offers a general framework and data on epidemiology, access to diagnosis, therapies, assistance, as well as on socio-health, legal and economic organisation, and it also highlights the strong points and criticisms of the Italian system of rare diseases. 

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