maria

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SAVE THE DATE. 17 April – EUCROF Webinar “Doing More with Data: Data Anonymisation and Pseudonymisation under the GDPR”

Registrations are still open for the new EUCROF webinar “Doing More with Data: Data Anonymisation and Pseudonymisation under the GDPR” that will take place on 17 April 2019. The webinarwill describe pseudonymisation and anonymisation techniques, specifically for clinical trial data, and how these fit within the GDPR regulatory framework. Many organisations are trying to exploit more value from their data to improve their products and services as well as to offer new ones and optimise their own internal operations. With the General Data Protection Regulation (GDPR) in place, these organisations need to determine the lawful basis for such activities. De-identification techniques, such as pseudonymisation and anonymisation, can play an important role in facilitating such secondary uses and disclosures of data. The webinar will be held by Khaled El Emam Founder, General Manager, and President of Privacy Analytics and is organised within the Events&Training working group of EUCROF. This Working Group (WG) has been launched with the aim to strengthen both events and training in the light of the educational vocation of all the activities EUCROF offers to its associates and external stakeholders. Donato Bonifazi, Chief Executive Officer at Consorzio per Valutazioni Biologiche e Farmacologiche, is the chair of the WG that intends to deliver activities to build relationships across organisational boundaries as well as to give training staff the opportunity to develop skills, expertise and grow within their role. For more information about the webinar and for registrations, click here.

2019-04-15T09:24:44+00:00 15/04/2019|Categories: News & Events|

SAVE THE DATE: the 2nd Kiev Clinical Research Forum will take place on May 16-17

PharmaSich, CRO in Eastern Europe headquartered in Kiev, will organise the 2nd Kiev Clinical Research Forum that will take place on 16 – 17 May 2019 under the patronage of EUCROF. Martine Dehlinger-Kremer, President of EUCROF, and Sergii Myronenko. CEO at PharmaSich CRO, are part of the Organising Committee of the event, that will bring together international experts from pharmaceutical/biotech companies, CROs, academia and regulatory agencies. This edition will see the participation of over 60 speakers representing pharma companies, CROs and academia coming from Europe, US, Israel. Donato Bonifazi, Chief Executive Officer at Consorzio per Valutazioni Biologiche e Farmacologiche and chair of the EUCROF Events and Training Working Group will participate in the meeting as speaker, explaining the importance and the role of the research infrastructures on the current scenario of the preclinical and clinical research and the possibility of CRO partnerships in this context. The overall aim of the meeting will be to share views and knowledge on clinical research among all the participants, providing networking opportunities and an adequate discussion moment between speakers and audience. More information and the agenda of the meeting is available at this link.

2019-04-15T08:15:05+00:00 12/04/2019|Categories: News & Events|

#wecare_ye: a new project for CVBF

We are very pleased to announce that the #wecare_ye project, coordinated by CVBF and funded within the European Programme Erasmus+, started in January 2019 with the aim to foster youth active participation in the field of Health and Wellbeing and support actions for the promotion of youth groups exchange in Belgium, the Czech Republic, Greece and Romania, based on the model of what has been achieved with the first Italian and Albanian Young Persons Advisory Groups, respectively named KIDS Bari and KIDS Tirana. Within this project, the partner organizations have selected 5 people per country (25 participants in total), aged 13-18 years, chosen among youngsters involved in their local activities: young patients, patients' relatives, youngsters interested to health in general. Moreover, each national group will be supported by one group leader per country, preferably under 30 years, selected among staff members. These youngsters involved have expressed a common need to gain a better knowledge on Health issues, in order to better influence their social and political environment. The project will act on 3 levels - knowledge, empowerment, engagement. KIDS Bari and KIDS Albania, born in 2017, include youths (both patients and healthy teenagers) actively involved in the definition of key issues and questions in the paediatric research projects as well as in the communication and sensitization activities about the healthcare by consciously using the social networks. Since the launch of these initiatives, the members of KIDS Bari and KIDS Albania have been providing a fundamental support in advising researchers in a full range of international initiatives to promote paediatric drug development. More information is available here.

2019-04-15T08:09:00+00:00 12/04/2019|Categories: News & Events|

EMA: Regulatory information – adjusted fees for applications to EMA from 1 April 2019

General, non-pharmacovigilance fees payable to EMA by applicants and marketing-authorisation holders are increasing by 1.7% on 1 April 2019. Every year, the European Commission adopts a regulation adjusting the fees payable to the Agency with reference to the inflation rate in the European Union for the previous year. The 2018 inflation rate was 1.7%. Full details of the new fee levels are available in Commission Regulation (EU) No 2019/480 amending Council Regulation (EC) No 297/95, its implementing rules and the corresponding explanatory note on fees, published on 1 April 2019. These documents include the new fees for all types of procedures handled by the Agency, except for pharmacovigilance procedures. For annual fees, the anniversary date of the decision granting the marketing authorisation defines the applicable fee and consequently a new fee will be applicable at the time of any anniversary on or after 1 April 2019. In addition, access to SME incentives for regulatory consultancies has been clarified (human and veterinary medicines). Fees charged for pharmacovigilance procedures in accordance with Regulation (EU) 658/2014 are expected to be revised in 2020, taking into account the 2018 and 2019 inflation rates.

2019-04-15T08:07:17+00:00 12/04/2019|Categories: News & Events|

18 March 2019: SPASD Workshop – Methodologies for an inclusive education: the course is ready

The Italian multiplier event, foreseen in the framework of the SPASD (Strengthening the Capacity of Professionals Working in Schools with Children and Young People with Autism Spectrum Disorder - ASD) project took place on 18 March 2019 at the University of Bari “A. Moro” and was focused on the “Innovative methodologies for an inclusive education”. SPASD is an international project funded within the European Programme Erasmus+  and arose from the willing to offer equal opportunities to children with ASD, as a main concern in all the countries involved in the project and also as an answer to the recent EU and national policies promoting equal possibilities in accessing education for all children and fostering the integration of children with disabilities into the general education system. To reach the project objectives, a e-learning course has been developed and distributed in the four countries involved in the project (Romania, Italy, Poland, Netherlands). The course addresses topics aimed to increase competences and skills of teachers which do not only concern providing high quality and inclusive classroom teaching but also providing support in the transfer of capabilities from school to community life for students with ASD and in building a partnership with parents in educating the child. In order to ensure dissemination of the information regarding the e-learning course among school headmasters, school inspectorate representatives, NGOs, press representatives, four multiplier events have been organised in each country involved in the project. Information regarding the content and knowledge provided by the e-learning course, condition for accession and registration, number of teaching hours provided, were provided to the participants in the Italian event, that was also the occasion to discuss and increase awareness on the importance of the inclusive education and [...]

2019-04-15T08:22:20+00:00 11/04/2019|Categories: News & Events|

ID-EPTRI 3rd General Assembly, 27-28 March 2019, Madrid: an update on the project and future perspectives

On 27-28 March 2019, the EPTRI (European Paediatric Translational Research Infrastructure) 3rd General Assembly meeting took place in Madrid at the Ministry of Health. The event was the occasion to take stock of the situation on the activities and the goals achieved in the first year of the project as well as the future perspectives and objectives of EPTRI , the European project, funded within H2020 Infradev-01-2017 call and coordinated by Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF) with the aim to design a new paediatric Research Infrastructure (RI), intended to accelerate paediatric drug development including most relevant technological innovations in research for children’s health. The first part of the event was dedicated to the workshop on Patient and Public Involvement in Research, underlining the necessity of paediatric patients’ involvement in the whole drug development process as well as the importance of the support of the Young Persons Advisory Groups (YPAGs) in the EPTRI project and overall in the health research. Moreover, a roundtable with the Stakeholders was held and involved representatives from Paediatric Networks, Research Infrastructures, ERNs (European Reference Networks), Charities, Patient’s associations, YPAGs (Young Patients Advisory Groups), Companies’ Federation, Regulatory Agencies, Governments, Authorities, with the aim to promote the entrance of EPTRI in a global framework of partnership able to strengthen paediatric research. The second day of the meeting was focused on the activities carried out in the context analysis of the project and provided the occasion to present the sustainability model of EPTRI in the European scenario as well as to discuss the role of each country in the building of this new RI.  Moreover, in the framework of the WP9 actvities a survey has been launched to acquire preliminary ideas and feelings from the [...]

2019-04-15T08:06:28+00:00 11/04/2019|Categories: News & Events|

Save the date! EPTRI Open Day Meeting in Madrid

In the framework of the next EPTRI General Assembly meeting that will be held in Madrid on March 27-28th, an Open Day Meeting will be organised on March 27th at the Ministry of Health. EPTRI (European Paediatric Translational Research Infrastructure) is a European project, funded within H2020 Infradev-01-2017 call for proposals and coordinated by Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF) with the aim to design a new pediatric Research Infrastructure (RI), intended to accelerate pediatric drug development including most relevant technological innovations in research for children’s health. The meeting will foresee a dedicated focus to patients through a workshop where the actors will be youth leaders of the Young Persons Advisory Groups (YPAGs) involved in the project, who will discuss about patient and public involvement in research. They will present their direct experience in the project and the contribution, current and potential, to the design of the new European Paediatric Translational Research Infrastructure aimed to bridge the gap represented by the lack of age-tailored paediatric medicines. The EPTRI project takes care of the voice of the patients and their families with dedicated tasks to facilitate the consultation and involvement of children and young patients and to ensure that the design of the future research infrastructure (EPTRI) is patient centered. The second part of the ´workshop on PPI (Patient and Public Involvement in Research) will focus more on the research activities of the four thematic platforms with the objective of developing a guidance with recommendations for the involvement of patients and their families in each of them. Moreover, a roundtable with the EU stakeholders will be held in the afternoon session involving representatives from paediatric networks, RIs, ERNs, charities, patients’ associations, YPAGs, companies’ federations, regulatory [...]

2019-04-04T07:33:40+00:00 19/03/2019|Categories: News & Events|

CVBF supports Rare Disease Day 2019: together to give voice to rare diseases

Even this year the 28th of February marks the International Rare Disease Day coordinated by EURORDIS  and CVBF has shown its support to this initiative that is aimed to raise awareness for rare diseases. A disease is defined as rare in Europe when it affects fewer than 1 out of 2000 and the 50% of rare diseases affect children. The lack of scientific knowledge and quality information on the diseases often results in a delay in diagnosis. Moreover, for many of them there is not an efficacious treatment.  This often results in heavy social and financial burdens on patients and their families. For this reason this initiative launched by EURORDIS intends to draw attention on the theme of rare disease and in particular, this edition is focused on “bridging health and social care”, focusing thus on bridging the gaps in the coordination between medical, social and support services in order to tackle the challenges that people living with a rare disease and their families around the world face every day. Since its launch in 2008 as a European initiative, this campaign has been successfully trying to draw the attention of both society and individuals, nations, governments and institutions to the matter of rare diseases, in order to intensify national politics relating to this subject and to heighten institutional standards of dealing with the challenges that a rare disease pose. CVBF has longstanding experience in the field of rare diseases and paediatric research with many EU funded projects in the field. Even for this reason, CVBF intends to raise awareness about Rare Disease Day through its social network pages and by showing its support on its official website. Moreover, the initiative has been mostly supported through  [...]

2019-02-28T14:27:19+00:00 28/02/2019|Categories: News & Events|

The 2nd Kiev Clinical Research Forum will take place on May 16-17

PharmaSich, CRO in Eastern Europe headquartered in Kiev, will organise, the 2nd Kiev Clinical Research Forum that will take place on 16 - 17 May 2019 under the patronage of EUCROF. Martine Dehlinger-Kremer, President of EUCROF, and Dr. Sergii Myronenko CEO at PharmaSich CRO, are part of the Organising Committee of the event, that will bring together international experts from pharmaceutical/biotech companies, CROs, academia and regulatory agencies. This edition will see the participation of over 60 speakers representing pharma companies, CROs and academia coming from Europe, US, Israel. Donato Bonifazi, Chief Executive Officer at Consorzio per Valutazioni Biologiche e Farmacologiche and chair of the EUCROF Events and Training Working Group will participate in the meeting as speaker, explaining the importance and the role of the research infrastructures on the current scenario of the preclinical and clinical research and the possibility of CRO partnerships in this context. The overall aim of the meeting will be to share views and knowledge on clinical research among all the participants, providing networking opportunities and an adequate discussion moment between speakers and audience. More information and the agenda of the meeting are available at this link.

2019-02-12T09:00:13+00:00 11/02/2019|Categories: News & Events|

A new EPTRI Webinar: “Social media to communicate science and r&d projects”

EPTRI (European Paediatric Translational Research Infrastructure) has designed a new webinar aimed to provide information on the different strategies to use social media as channel for science communication. The webinar is addressed to researchers, institutions, clinicians and people interested in science and institutional communication and has the scope to show how to choose the adequate social media channel in order to reach the desired target and disseminate scientific topics through these platforms. This webinar is free and will take place next January 10th 2019 at 4 pm CET. It will be given by Estibaliz Urarte, Communications Manager at the Patient Engagement in Research Area of Sant Joan de Déu Foundation (FSJD) and Mariangela Lupo, Head of the Networking area at Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF), coordinator of the EPTRI project. To register, click on the following link: http://bit.ly/2Ejk114  

2018-12-14T21:52:22+00:00 14/12/2018|Categories: News & Events|