In order to support the sharing of information on performed or planned studies and increase the efficiency of research, the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) and the European Medicines Agency (EMA) strongly encourage...
COVID-19: what is the current situation of the International Authorities
A pneumonia of unknown cause detected in Wuhan, China was first reported to the World Health Organisation Country Office in China on 31 December 2019. After just three months WHO characterised COVID-19 as pandemic, currently affecting 157 countries and territories...
The activities of KIDS Bari keep on!
The activities of the Italian Young Persons Advisory Group (YPAG), KIDS Bari, keep on and this year will be focused on the development of a serious game on the theme of Paediatric Clinical Research and Clinical Trial Center, as a playful training tool for the young...
SAVE THE DATE. EPTRI Open Meeting. 2-3 April 2020, Brussels
EPTRI (European Paediatric Translational Research Infrastructure) has announced the EPTRI Open Meeting that will be held on April 2-3 April 2020 at the President Brussels Hotel. EPTRI is an EU funded project coordinated by Consorzio per Valutazioni Biologiche e...
EMA overview of its key recommendations in 2019 on the authorisation and safety monitoring of medicines for human use.
On January 2020, the European Medicines Agency (EMA) published an overview of its key recommendations in 2019 on the authorisation and safety monitoring of medicines for human use. In 2019, EMA recommended 66 medicines for marketing authorisation. Of these, 30 had a...
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 took place on 29 February 2020. The first Rare Disease Day was celebrated in 2008 on 29...
1500 downloads for the article “Clinical Trials in Paediatrics — Regulatory and Methodological Aspects”
In June 2014, IntechOpen Book, one of the world’s leading publisher of open access books, published the book entitled “Drug Discovery and Development - From Molecules to Medicine”, including a chapter written by Professor Adriana Ceci and experts from Gianni Benzi...
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...
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...
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...