WHAT'S NEW Highlights on our activities and initiatives
THE INTERNATIONAL HEMOGLOBINOPATHY RESEARCH NETWORK: NEW ARTICLE PUBLISHED
A paper about the recently formedInternational Hemologlobinopathy Research Network – INHERENThas been published in the American Journal of Hematology. The article presents INHERENT as an international network focused on the study of genetic modifiers for haemoglobinopathies through a large-scale multi-ethnic genome-wide association (GWAS) study. INHERENT will study how genetic modifiers influence the diverse clinical manifestations and the varying degree of severity of haemoglobinopathies, including Thalassemia syndromes and Sickle Cell Disease. Fondazione Benzi is actively involved in the network activities as coordinator of the Ethics Working Group.
The 2021 edition will be held from September 27 until October 3! Fondazione Benzi will participate in the European Biotech Week, as partner of theEuropean Paediatric Translational Research Infrastructure (EPTRI)that willorganise the two events: "The biotech approach to paediatric medical devices" (Prof. Paul Dimitri and Prof. Annelie Weinberg) on 29th of September at 15.00 CEST. "Paediatric formulations carrying biotech drugs: special focus on Covid-19 vaccines" (Prof. Nunzio Denora and Dr. Viviana Giannuzzi) on 1st of October at 11.00 CEST.Discover more - Visit the European Biotech Week website
ACROSS THE WORLD Updates and latest news across the world
WHO GUIDANCE FOR STRONG, EFFICIENT AND SUSTAINABLE REGULATORY SYSTEMS
The World Health Organization (WHO) has published the Good Regulatory Practices (GRP) and Good Reliance Practices (GRelP) that will be critical for countries’ regulatory system strengthening cooperation, convergence and transparency to leverage resources more efficiently and ensure that quality health products reach people faster. The globalization of markets, the sophistication of health technologies, the rapid evolution of regulatory science and the increasing complexity of supply chains have shown regulators the importance of international cooperation in ensuring the safety, quality, efficacy or performance of locally used products. You can find both documents as annexes 10 and 11 in the 55th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP).
The European Medicines Agency released the draft ICH guideline E6 on good clinical practice (GCP) in June 2021.
The International Council for Harmonisation (ICH) is committed to developing technical requirements for pharmaceuticals for human use in a manner that is responsive to the needs of the global community. This guideline is currently under development by the ICH E6(R3) Expert Working Group (EWG). The renovation of GCP will align its principles with ICH E8(R1) Revision of General Considerations for Clinical Studies, in particular for clinical trials quality, stakeholder engagement, trial design, proportionate trial management. ICH E6(R3) will also provide additional considerations for non-traditional interventional trials.
9TH REVISION OF THE ENCEPP GUIDE ON METHODOLOGICAL STANDARDS IN PHARMACOEPIDEMIOLOGY
The 9th revision of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance - ENCePP Guide on Methodological Standards in Pharmacoepidemiology has been published. This Guide offers a single web resource for methodological guidance in pharmacoepidemiology, considering the internationally agreed recommendations and key points from important guidelines, published articles and textbooks. The importance of the Guide in the context of the COVID-19 pandemic and vaccination campaigns has been pointed out. Nearly all chapters contain relevant guidance on methodological standards to be used in COVID-19 studies.
4TH EDITION OF THE TIF GUIDELINES FOR THE MANAGEMENT OF TRANSFUSION- DEPENDENT THALASSAEMIA NOW AVAILABLE
Thalassaemia International Federation (TIF) has published the 4th Edition of the TIF Guidelines for The Management of Transfusion-Dependent Thalassaemia (TDT). TIF Guidelines have been adopted and used extensively by academics, researchers and healthcare professionals all over the world as the only evidence-based reference text concerning the treatment of patients with TDT. The newly launched edition includes new chapters on the recently approved modalities of patient treatment, as well as the value of patient engagement at the decision-making level and the Reference Centres’ contribution to patient care.
NEW DATA ON THE DURATION OF IMMUNE PROTECTION AGAINST SARSCOV-2 IN CHILDREN
Researchers from the University of Padua and the Italian health authority and the research organization for animal health and food safety (IZSVe), in collaboration with Padua Hospital, Penta Foundation, Bambino Gesù Paediatric Hospital and the University Milano-Bicocca, have published the article “Mild SARS-CoV-2 Infections and Neutralizing Antibody Titers” on thePediatrics journal. It shows the results from an observational study that demonstrates how in asymptomatic or mildly symptomatic subjects, the antibody response against SARS-CoV-2 in children is superior and longer lasting than in adults.