28th January 2021

Newsletter January 2021


WEBINAR – Cooperative Groups in Italy and clinical research 

Wednesday 20 January 2021 at 3 pm SIMeF (Italian society of pharmaceutical medicine) has held the webinar “Cooperative Groups in Italy and clinical research”. Donato Bonifazi, CEO at CVBF, moderated the webinar and presented EPTRI, the European Paediatric Translational Research Infrastructure as an example of a wide collaborative group linking 112 research Institutions in Europe.
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Joint strategy sets direction for EMA and EU medicines regulatory agencies to 2025 

The pandemic crisis has shown many problems linked to medicines and the mechanism ahead of their regulation. For this reason, EMA (European Medicines Agency) and HMA (Head of Medicines Agencies) came together to look ahead and develop an overarching European medicines agencies network strategy.
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Revision of the EU legislation on medicines for children and rare diseases 


On 25 November 2020, the European Commission published the Inception Impact Assessment on the revision of the Orphan and Paediatric Regulations. The public consultation was closed on 6 January 2021 and served to collect opinions and suggestions from the different stakeholders and explore the need for adequate measures to address several shortcomings in the functioning of the existing European paediatric framework.
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CVBF will be involved in a new clinical study: RACERS

We are delighted to inform you that CVBF will provide its support in the RACERS study, a new clinical trial approved by AIFA (Agenzia Italiana del Farmaco) and coordinated by the University Hospital Polyclinic of Bari. Acute Kidney Injury (AKI) is a common occurrence in patients hospitalized in the Intensive Care Units, with an estimated incidence of more than 50%
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Child exclusion: how COVID19 has drastically changed children’s lives

Unfortunately, it’s well known that the pandemic has transformed everybody’s life. This is particularly true in case of children, apparently less attacked by the virus. Although children infected with COVID-19 are fewer than adults, since February 2020 they are suffering from a series of problems linked to health and lifestyle.
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Registers of potential industrial partners for translational research

The Project “KISS – Knowledge Information Sharing Strategy” coordinated by the Istituto Tumori “Giovanni Paolo II” and funded by the Italian Ministry of Economic Development is recruiting Italian Industrial Organisations operating in the technological innovation sector for translational research with the aim to create a Register of potential partners in finding possible technological solutions for the prevention, diagnosis and treatment of oncological diseases.
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DIVA: Final event of the project
January 21, 2021 

DIVA (Innovative Devices for the prevention of recurrent VAginitis), project focused on the development of an innovative treatment for vaginitis in order to reduce the use of antibiotic therapy, has come to its conclusion.
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Moderna Sets U.S. Trial for Assessing COVID-19 Vaccine in Teenagers

Last December 10th, 2020 on the official website of the pharmaceutical company Moderna was announced the plan to begin a phase 2/3 Covid-19 vaccine trial including adolescents between 12-18 years old.
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SAVE THE DATE. 04 February 2021
How Can Europe Enhance the Benefits of AI-Enabled Health Care?

Artificial intelligence (AI) conjugated to medicine is making many steps forward, but these innovations do not always bring the desired results. Often, still today, there is no proper use of technologies due to lack of ability to use certain devices.
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SAVE THE DATE. 11 February 2021
EFGCP Webinar Paediatric Clinical Trial Preparedness: New Enpr-EMA Guideline 

On Thursday 11 February  from 5 to 6.30 (CET), EFGCP, the European Forum for Good Clinical Practice, will hold the webinar “Paediatric Clinical Trial Preparedness: New Enpr-EMA Guideline”. Daily, researchers face the problem of delays in the conduct and completion of paediatric clinical trials when medicines for children are developed.
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About the Author: Flogert Dollani


By Published On: January 28th, 2021Categories: Newsletter0 Comments