30th September 2021

Newsletter September 2021


1st International Conference on Rare Diseases and Paediatric research 


Join the 1st International Conference on Rare Diseases and Paediatric Research that will be held virtually on 18-19 November 2021 in Athens, Greece! The Conference will be an opportunity to be updated of all current developments, be an active participant and contribute to this European discussion.
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CVBF is organising Modelling&Simulation workshop within EJPRD

TheModelling&Simulation: Research Methodologies for Small Populations in Rare Diseases” workshop aims at putting forward a cross-cutting topic while targeting a specific area of improvement, i.e. the application of innovative methodologies (use of PK-PD data for M&S and extrapolation principle application) for RD drug development. It is organised within the EJPRD ERN Research Workshop framework and will be held in Spring 2022
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My Clinical Trial Center serious videogame

My Clinical Trial Center (My CTC) videogame aims at explaining to children in a fun way what clinical trials are, how they work and why they are so important to developing drugs suitable for children. It is extremely informative, as game-players will learn about clinical trial, study protocol, informed consent and assent in children, phases and procedures of clinical trials, data collection, and pharmacovigilance.
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CVBF adopted Family Audit Certification

Family Audit is an important certification qualifying an organisation’s commitment to a favourable work-life balance of its employees. By adopting the Family Audit certification, CVBF has started a cycle of continuous work-life conciliation measures with the introduction of organisational solutions, such as flexible work hours and smart working.
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CVBF has been included as an Observer in the EOSC Association

The EOSC Association brings together key stakeholders in the European research environment to agree on strategies for the advancement of Open Science and to optimise the conditions for research outcomes, and ultimately, to make the European Open Science Cloud (EOSC) a reality.
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Share4Brain Project’s meeting in Athens

The Share4Brain Project meeting was held on 23-24 of September 2021 at Amarilla hotel in Athens, Greece. Greek policymakers such as MEP Stelios Kymporopoulos, the member of the Hellenic Parliament Mrs Marietta Gianakou, and the mayor of the city of Vouliagmeni Mr Grigoris Konstantellos endorsed the Athens meeting.
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Kids suffer serious adverse reactions in AGTC gene therapy trial


“Part of the reason to do a dose escalating study is to identify if there is a maximum tolerated dose. That’s exactly what we think we’ve identified here for paediatric patients. And it shouldn’t be all that surprising in the realm of drug development that a maximum tolerated dose for paediatrics might be different than a maximum tolerated dose for adult patients,” CEO Sue Washer said on a conference call with investors.
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UCL Repurposing TIN Seminar: How partnership drives innovation
6 October 2021 

This Repurposing TIN Seminar will discuss how collaborations are key to innovation in drug repurposing. CVBF CEO and EPTRI Coordinator, Donato Bonifazi, will participate as a speaker with a presentation on EPTRI as a Strategic Multi-Stakeholder Partnership for Paediatric Research, from 15:30 to 17:30 CEST. Registration is open and the event is for free.

Webinar for SMEs and Academia on the Clinical Trial Regulation (Regulation (EU) No 536/2014) and the Clinical Trials Information System (CTIS)
21 November 2021

On November 29th, 2021, EMA is organising a webinar to inform small and medium-sized enterprises (SMEs) and academic sponsors of clinical trials on how to prepare for the main changes brought by the Regulation and its impact on their trial-related activities. Participation is by invitation only and limited to SMEs registered with EMA, academia and representatives of stakeholder organisations. More information is available on the EMA website.

EUCROF webinar: Future of Clinical Trials: Navigating Complexities to Increase Investigator Satisfaction,
5 October 2021

This webinar on the future of clinical trials will provide the tools to navigate complexities while increasing investigator satisfaction. Starting with an analysis of how the shift to decentralized trials enhances investigator’s accountability, the webinar will help you to examine how to ensure your approach brings the needed support to investigators to enrol and retain patients. Register now!

Personalised Medicine Current Applications in Clinical Research and Regulatory Framework Date & Time
2 November 2021

Join the EUCROF training on Personalised Medicine: Current Applications in Clinical Research and Regulatory Framework that will be held on 2 November 2021 in Munich (Germany), from 9:00 AM to 17:00 PM (CET). The training is organised by the EUCROF Events & Training Working Group, chaired by Donato Bonifazi, and can be attended also virtually. For more information and registration (deadline 28 October 2021) click here.

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About the Author: Flogert Dollani


By Published On: September 30th, 2021Categories: Newsletter0 Comments