ENCePP is the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance coordinated by the European Medicines Agency (EMA) aimed to strengthen the monitoring of the benefit-risk balance of medicinal products in Europe.
On 31th May, 2017 the European Medicines Agency (EMA) published an action plan for small and medium-sized enterprises (SMEs), which aims to foster innovation and support SMEs in the development of novel human and veterinary medicines. This action plan builds on existing measures introduced to support SMEs pursuant to Commission Regulation (EC) No 2049/2005 and addresses the
On 25th, July 2017, the European Medicines Agency (EMA) published a revision of the guidance on first-in-human clinical trials, that will come into effect on February 1st, 2018. The guidance addresses non-clinical issues for consideration prior to the first administration of an investigational medicinal product in humans. It also focuses on the design and conduct
In July 2017, the Article “Tuberculosis treatment for children: An update” has been published on-line in “Anales de Pediatría” Journal. The publication reports the updated international guidelines for the management of paediatric Tuberculosis (TB) in Spain, reviewed by a group of paediatric TB experts, among which some researchers of the TEDDY Network, such as Maria
Consorzio per Valutazioni Biologiche e Farmacologiche – Dege e shoqerise se huaj, Albanian Branch Office in collaboration with the TEDDY Network (European Network of Excellence for Paediatric Clinical Research) and University Hospital Center Tirana “Mother Teresa”, Service of Paediatrics), promoted the first YPAG (Young People Advisory Group) in Albania, named KIDS Albania. KIDS Albania
The article “Investigating the roles and training of paediatric research nurses working across Europe: a questionnaire-based survey”, aimed to identify potential training needs and compare the roles of research nurses across specialties and countries, has been published in BMJ Paediatrics Open 2017. Research nurses represent key figures among the clinical trial personnel to conduct a
Also this year the Gianni Benzi Pharmacological Research Foundation organises the annual Foresight Training Course (FTC), at its tenth edition now. The meeting, entitled ‘THE EUROPEAN MEDICINES REGULATORY NETWORK: PRESENT AND FUTURE’, will focus on: – the main innovations in the European Pharmaceutical System; – putting patients in the core of the system; – the
We are very pleased to announce that the ID-EPTRI (European Paediatric Translational Research Infrastructure) project, coordinated by CVBF and submitted within the INFRADEV-2016-2017 single-stage call for proposals, aimed to create the framework for a new paediatric Research Infrastructure (RI) has been successfully evaluated and granted 3.00 million Euro in funding from the European Commission.
The TEDDY network is working to launch a series of collaborative operating groups, focused on the most relevant topics of paediatric clinical research. This action is intended to convey the Network expertise and experience to deliver useful instruments for the promotion and the concrete support of paediatric clinical research. It arises from the collaborative nature
From 1 June 2016 to 31 August 2016 the Directorate General for Health and Food Safety, DG SANTE launched a public consultation with the aim to seek the views of stakeholders and other interested parties, on the "Summary of Clinical Trial Results for Laypersons", which has been developed by the expert group on clinical trials