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Newsletter no. 10 - April 2021

WHAT'S NEW
Highlights on our activities and initiatives

PedCRIN WEBINARS

PedCRIN lauched a webinar series to share some of the most interesting outcomes of the project. The series will be completed by the PedCRIN Final Meeting that will be held on June 16, 2021.
The webinars will be the opportunity to discover more about the tools developed through PedCRIN for the setup and management of paediatric and neonatal clinical trials.
The first webinar was held on April 7, 2021 at 1:00PM CEST and was dedicated to the tools for managing paediatric trials. Viviana Giannuzzi from Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus partcipated as speaker.

Register here - Discover more

FONDAZIONE BENZI AT THE 40° NATIONAL CONGRESS OF THE ITALIAN SOCIETY OF PHARMACOLOGY

Fondazione Gianni Benzi took part in the 40° National Congress of the Italian Society of Pharmacology (SIF) “Il valore scientifico e l’uso appropriato del farmaco“, that run virtually from 9th to 13th March 2021. The congress was the occasion to learn more and exchange knowledge in the pharmacological field that is going through an important and transformative period. Pharmacology plays a central role through new research methodologies, advanced therapies (e.g., gene and cell therapies), Artificial Intelligence application, Big Data and personalised medicine, considering the whole research process, from the preclinical, through translational to clinical research. 

Our contribution - Visit SIF website

NEW PUBLICATION ON PAEDIATRIC CLINICAL RESEARCH IN EUROPE

The collaborative work “Paediatric clinical research in Europe: an insight on experts’ needs and perspectives”, developed within the Paediatric Clinical Research Infrastructure Network - PedCRIN project, was recently published on Contemporary Clinical Trials Communications journal.
The manuscript aims to capture the needs of stakeholders involved in paediatric clinical research to receive infrastructural support to cover specific paediatric research gaps.
We actively participate, as third party of Consorzio per Valutazioni Biologiche e Farmacologiche, in the PedCRIN project by providing knowledge and expertise to develop and adapt tools supporting the conduct of neonatal and paediatric trials to be used for multinational paediatric clinical trials.

Discover more  - Read the full article 

ACROSS THE WORLD
Updates and latest news across the world

SAVE THE DATE – EJP RD MASSIVE OPEN ONLINE COURSE 

The first European Joint Programme on Rare Diseases EJP RD MOOC (Massive Open Online Course) “Diagnosing Rare Diseases: from the Clinic to Research and back” has started on Tuesday April 27th, 2021. The course will be open for free for 7 weeksThis course is designed for individuals with a keen interest in diagnostic research and rare diseases. While primarily designed for medical students and PhD/post-doc students in biomedical sciences, it will also be of interest to Patients Advocacy Organisations’ representatives, Healthcare professionals or paramedics who want to further their knowledge of rare diseases diagnosis.

 Register for the event

SAVE THE DATE: 68TH SIARV WORKSHOP

The Italian Society for Regulatory Activities, Access, PharmacoVigilance – SIARV, is organising the 68th SIARV workshop “Strumenti regolatori nel nuovo Mondo post Covid” that will be held online on May 28th, 2021 from 09:30AM to 05:30PM CEST.
The course aims to investigate and describe the evolution of changes due to the ongoing pandemic that significantly impacts on many regulatory, drug access and pharmacovigilance procedures.
Please consider that the course will only run in Italian language.

 

EMA PREPARING NEW COVID-19 VACCINES STRATEGIES TO FIGHT SARS-COV-2 VARIANTS

The human medicines committee (CHMP) at the European Medicines Agency (EMA) has issued a reflection paper outlining the requirements for manufacturers planning to modify their COVID-19 vaccines in order to address SARS-CoV-2 variants.
Viruses typically mutate and several variant strains of SARS-CoV-2 have already been identified worldwide. Mutations may impact on the disease transmission or severity as well as on the effectiveness of diagnostics, therapeutics or vaccines.
The EMA reflection paper details the laboratory (non-clinical), clinical, quality and manufacturing data required to support the approval of ‘variant’ vaccines whether monovalent or multivalent.

Discover more - Read the EMA reflection paper

 

GDPR AND HEALTH RESEARCH: REQUEST FOR CLARIFICATION

The European Data Protection Board (EDPB) released the Document on response to the request from the European Commission for clarifications on the consistent application of the GDPR, focusing on health research. This document includes a list of questions and answers on data processing for health-related research, as submitted by the European Commission (DG Justice and Consumers) to the EDPB under Article 70 of the General Data Protection Regulation, to solve some misunderstandings and misinterpretations related to the application of the GDPR to the domain of scientific health research.

Discover more - Read the full document

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