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On 26 March 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Ruconest (conestat alfa). The marketing authorisation holder for this medicinal product is Pharming Group N.V. The Committee for Medicinal Products for Human Use (CHMP)

The 10th European Conference on Rare Diseases & Orphan Products (ECRD) will take place ONLINE on 14-15 May The ECRD is recognised globally as the largest, patient-led rare disease event in which collaborative dialogue, learning and conversation takes place, forming the groundwork to shape future rare diseases policies. Leading, inspiring and engaging all stakeholders to

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 around the world. Besides the impact on international financial market and individual social life, COVID-19

Medical devices make an essential contribution to healthcare in the EU for the benefit of European citizens. From sticking plasters to X-ray scanners, dentures to hip joints and in-vitro diagnostic devices that monitor diabetes or identify infections, medical devices are crucial in diagnosing, preventing, monitoring and treating illnesses, and overcoming disabilities. Medical devices within the

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 all researchers to register their pharmacoepidemiological studies related to the Covid-19 pandemic in the EU PAS Register available

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 around the world. Besides the impact on international financial market and individual social life, COVID-19

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 Farmacologiche and aimed to design the framework for a new infrastructure dedicated to paediatric research that

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 Foundation and the TEDDY Network. The chapter, entitled “Clinical Trials in Paediatrics — Regulatory

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 new active substance which had never been authorised in the EU before. In