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Newsletter no. 16 - May 2022

COLLABORATIVE RESEARCH
Last updates on our collaborative research projects

EPTRI 1st INTERNATIONAL CONFERENCE ON RDs AND PAEDIATRIC RESEARCH

The 1st International Conference on Rare Diseases and Paediatric Research, organized by EPTRI, was a virtual event held on November 18-19, 2021.
Sessions are now available and can be watched on-demand. If you were not able to attend, you can access the material until August 31st, 2022.


Access the sessions

ACROSS THE WORLD
Updates and latest news across the world

ICH-GOOD CLINICAL PRACTICE TRAINING COURSE 

Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF) is pleased to present its e-learning “ICH-Good Clinical Practice (GCP) Training Course”, aimed at providing a guide for all professionals involved in clinical research and clinical trials that need to acquire GCP knowledge.
This training course is intended to provide indication for all the steps of a clinical trial, starting from the planning phase and Ethics Committee submission, passing through the trial conduction and up to the reporting of results. Registration is open.

Discover more - Visit CVBF website

SUMMARY REPORT ON THE PUBLIC CONSULTATION ON THE REVISION OF THE GENERAL PHARMACEUTICAL LEGISLATION NOW AVAILABLE 

The summary report on the public consultation on the revision of the general pharmaceutical legislation has been recently published. The public consultation, launched by the European Commission in 2021, aimed to collect views of different stakeholders to support the evaluation of the existing general pharmaceutical legislation on medicines for human use, and the impact assessment of its revision to ensure a future-proof and crisis-resistant medicines regulatory system.
Overall, 478 contributions were submitted to the public consultation by December 2021. Six campaigns were identified by using a combination of statistical and manual approach to analyse the received responses.

Discover more - Read the full report

ICH GUIDELINE ON PAEDIATRIC EXTRAPOLATION

The European Medicines Agency adopted the ICH guideline E11A on pediatric extrapolation. This guideline provides recommendations for harmonised approaches for paediatric extrapolation to support the development and authorisation of paediatric medicines.
It aims to provide a framework for using extrapolation as a tool to support paediatric drug development that encompasses an iterative process for understanding the existing information available, the gaps in information needed to inform development and ways to generate additional information when needed.

Discover more - Read the guidelines

PUBLICATIONS
Our recent publications and other editorial activities

SPECIAL ISSUE “PERSONALIZED MEDICINE IN BLOOD DISEASE OF CHILDREN”: SUBMIT YOUR PAPER

Do you deal with child blood non-malignant diseases? Are you interested in personalised medicine and biomarkers or genomics as well as digital science?
We are pleased to invite you to submit your manuscript to the Special Issue "Personalized Medicine in Blood Disease of Children" of the Journal of Personalized Medicine.
It highlights the current state of the research and current practice on personalised medicines in children blood non-malignant disorders, such as haemoglobinopathies and bleeding disorders.
Deadline for manuscript submissions is 5 September 2022.

Discover more - Visit the journal website

EPTRI SPECIAL ISSUE

The Pharmaceutics journal dedicated the special issue "Scientific Highlights in the First European Paediatric Translational Research Infrastructure (EPTRI) Open Meeting" to highlight this important event that was organized by EPTRI last December online.
Ten presentations were held to sum up the activities carried out so far and the short and long-term ambitions and plans of EPTRI.

 

CALLS FOR FUNDING
Funding opportunities within relevant research programmes 

EJP RD – ERN RESEARCH MOBILITY FELLOWSHIP FUNDING OPPORTUNITY

EJP RD is glad to announce the opening of the call for Research Mobility Fellowships, which aims to support PhD students, postdocs and medical doctors in training to undertake scientific visits fostering specialist research training outside their countries of residence. Deadline is on 13 June 2022.
Applicants should acquire new competences and knowledge related to their research on rare diseases, with a defined research plan and demonstrable benefit to the ERN of the home and/or host institution.

Discover more - Visit the EJP RD website

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