The upcoming Clinical Trial Regulation requires the development and dissemination of Lay Summaries of clinical study results from commercial and non-commercial sponsors. However, there is no guidance for all types of sponsors on how best to handle the development...
EUCROF Webinar on “The Patient Centricity Effect – How it benefits Patients, Sites and Sponsors – Practical Cases from Paediatric Studies”. 25 February 2020
The Events&Training Working Group of EUCROF (European CRO Federation) organised the Webinar “The Patient Centricity Effect - How it benefits Patients, Sites and Sponsors – Practical Cases from Paediatric Studies” that was held on 25 February 2020. Patient...
TEDDY Network supports RARE DISEASE DAY
Even this year TEDDY Network supports the Rare Disease Day, the thirteenth edition of the international initiative promoting awareness-raising activities on Rare Disease and that will take place on 29 February 2020. The first Rare Disease Day was celebrated in 2008 on...
Xromi obtained marketing-authorisation for the prevention of vaso-occlusive complications of Sickle Cell Disease in patients over 2 years of age
In April 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Xromi. It is a medicine used in adults, adolescents and children over two years of age...
Zynteglo obtained marketing-authorisation for the treatment of beta thalassaemia in patients 12 years and older
In March 2019, the Committee for Medicinal Product for Human Use (CHMP) on the basis of the draft Committee for Advanced Therapies opinion, adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Zynteglo, intended...
Deferasirox Accord: on November 2019 CHMP recommended the marketing authorisation for the medicinal product Deferasirox
In November 2019, the Committee for Medicinal Product for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Deferasirox Accord, a generic product of DESFERAL Novartis, intended for the...
FDA Consultation: FDARA Implementation Guidance for paediatric studies of molecularly targeted oncology drugs. Amendments to Sec. 505B of the FD&C Act guidance for industry
On December 2020, the Food and Drug Administration released a draft guidance for industry entitled “FDARA Implementation Guidance for Paediatric Studies of Molecularly Targeted Oncology Drugs”. This draft guidance addresses early planning for paediatric evaluation of...
Call for abstract EPTRI Open Meeting
EPTRI (European Paediatric Translational Research Infrastructure) has announced a Call for Abstracts for the EPTRI Open Meeting that will be held on April 2-3 April 2020. EPTRI is an EU funded project coordinated by CVBF and aimed to design the framework for a new...
Emanuela Ruscitto from KIDS Bari shared her creative idea for year-end thanks from iCAN
It is possible to capture and communicate the essence of International Children's Advisory Network (iCAN) through the art? Can a drawing explain the importance of the role of iCAN organisation? This was asked to Emanuela Ruscitto, one of the members of KIDS Bari, who...
COMING SOON. EFGCP & EFPIA Workshop “Roadmap Initiative to Good Lay Summary Practices”, 15 January 2020, Bruxelles
On 15 January 2020, the EFGCP & EFPIA Workshop "Roadmap Initiative to Good Lay Summary Practices” will be held in Brussels. The upcoming Clinical Trial Regulation requires the development and dissemination of Lay Summaries of clinical study results from commercial...