European Medicines Agency (EMA) is organising its second Awareness Session, in London, on 8-9 March 2018. The full title of the event is “Second international awareness session for international regulators, academia and non-governmental organisations” and it is aimed to provide insight into the EU regulatory system and the role of the EMA, into scientific aspects of EMA's work and its interaction with scientific experts. Many topics will be addressed during the session: Advance Therapies Medication (ATMPs), Clinical trials in the EU, EMA support to innovation, dealing with specific populations and types of products (with a focus on paediatric and orphan medicines), Good Practices, the role of experts and benefit-risk evaluation, patient safety and pharmacovigilance, international cooperation. The event will also provide the participants with networking opportunities with academics, NGOs staff and regulators from and outside the EU. The event will be broadcasted live and EMA will publish further materials after the event. Please visit the link for further information and to vision the programme.
The BIAT event - Borsa dell’Innovazione e dell’Alta Tecnologia - that will take place in Naples, Italy, on 19th-20th April 2018, is an international travelling event within the initiatives “Piano Export Sud II”, a program of actions for the promotion of internationalization and business innovation. The aim of the event is to enhance the innovative potential of companies and research organizations of the Italian Southern Regions (Campania, Calabria, Apulia, Sicily, Abruzzo, Molise, Basilicata, Sardinia), in order to obtain products and services to be exported on foreign markets. Many Foreign counterparts (large companies, research centers interested in technology transfer, venture capitalists and investors) coming from the following countries: Belgium, Canada, China, Korea, Denmark, United Arab Emirates, Russia, France, Germany, Japan, India, Israel, Holland, Poland, United Kingdom, Singapore, United States, Sweden and Turkey will take part in the event and will meet the Italian participants in dedicated B2B meetings. CVBF will attend the event promoting the EPTRI project, aimed to design EPTRI, a new research infrastructure dedicated to the paediatric field and with the mission to promote and foster the availability of medicines for children by enhancing and supporting the early stages of drug development (discovery and early development phase). More information on the event is available at the following link. A dedicated page to EPTRI has been published on the official BIAT 2018 catalogue.
The ID-EPTRI project has been launched in Rome on 15th-16th January, 2018 at the Ministry of Education, University and Research (MIUR), with more than 100 attendees. The project has been funded within the INFRADEV-01-2017 H2020 call for proposals to realise a new Research Infrastructure (RI) completely dedicated to paediatrics and involves 26 partners from EU and non-EU countries including consolidated research infrastructures, top-level universities, scientific and clinical centres of excellence in Europe. EPTRI, the European Paediatric Translational Research Infrastructure, will act as a “Paediatric Common Service” aimed to promote availability of safe and effective medicines for children. EPTRI will seek to reach this important goal putting together researchers working in different areas and on different topics but with a common interest in paediatrics to identify which are the most challenges they meet in their work and how to overcome them integrating technology-driven approaches to drug discovery and development. To this aim, five specific topics/research areas have been identified, named thematic platforms: 1-Paediatric Medicines Discovery, 2-Biomarkers, 3-Paediatric Pharmacology, 4-Formulation Science, 5-Underpinning Paediatric Studies. To prepare the Conceptual Design Report (CDR) to realize EPTRI, the project will encompass three phases: a Context Analysis phase, to estimate the possible gaps and challenges to be covered in the paediatric research field and how the new RI is perceived by the scientific communities, the concerned national Authorities and many other stakeholders; an Operational phase, to plan how to build the new RI defining the governance model, strategies for interaction with national Authorities and the existing RIs, the IT-architecture model, services to be provided and a business plan. a Feasibility phase, to simulate, through the development of virtual exercises, how EPTRI will practically support the development of medicines for children. The [...]
Rome, January 14th, 2018. The TEDDY General Assembly (GA) entitled “A new phase for paediatric clinical research: a play role for TEDDY?” was held in Rome to provide an update on the achievements reached by the Network over the last years. Since 2005, when the Network arose from the Task-force in Europe for Drug Development for the Young and was funded within the Sixth Framework Programme of the European Commission, it has reached several goals, becoming category 4 Member of Enpr-EMA (European Network of Paediatric Research at the European Medicines Agency) in 2014 and category 1 in 2016. In 2018, TEDDY has assumed a legal status to be fully represented in the European paediatric research framework. The TEDDY GA was the occasion to discuss about the future perspectives of the TEDDY Network as International subject in the European scenario. After an overview on the evolution of the TEDDY Network and the main milestones reached by the Network over the last years, it was presented the new TEDDY statute that allows the adhesion of natural and legal persons within two categories of members: Ordinaries (they are physical persons participating to the network activities) and Supporters (they are legal entities contributing to the network activities). During the morning session, TEDDY operative groups and their plans of action were presented: Standard Operating Procedures for the conduct of paediatric clinical trials; Ethic Issues and interactions with Ethic Committees; Off-label medicines use in paediatrics; Regulatory procedures for paediatric clinical trials; Inventory of clinical sites and facilities for clinical trial feasibility; Pharmacovigilance; Active engagement of children and adolescents in the themes of clinical research; Advanced therapies in paediatrics. The afternoon section began with the discussion about the TEDDY Network Bodies. All [...]
The 4th European Conference on Clinical Research will be held on Monday 26th and Tuesday 27th February in Vienna, Austria. The conference will be focused on the need for knowing, understanding and adhering to the multiple regulatory requirements and guidelines, which are being released in Europe as underlined in the theme chosen for the 2018 Conference: “Are You Ready to Embrace the Changes?”. The 2-days programme includes many interesting sessions dedicated to the Clinical Trials Regulation (EU) No 536/2014, GCP - the new addendum E6 (R2), the European Medical Device Regulations, the new European Data Privacy Regulation, clinical trials in the paediatric population and many others. The conference is open to all stakeholders of clinical research field in Europe: regulators, pharmaceutical companies, medical devices companies, biotechs, large and small CROs, patient associations or advocacy groups, academic researchers. More than 30 speakers, experts in their fields, will give the attendees the opportunity to face the ever-changing world of clinical research, to be prepared for the upcoming changes. Further information is available here.
Again this year CVBF is glad to support The Rare Disease Day 2018, that will take place on 28th February 2018, to raise awareness of rare diseases and their impact on patients' lives amongst the general public and decision-makers. The Rare Disease Day was first launched by EURORDIS and its Council of National Alliances in 2008, but soon this initiative spread all over the world involving 94 countries un 2017. A disease is defined as rare in Europe when it affects fewer than 1 out of 2000 and the 50% of rare diseases affect children. The lack of scientific knowledge and quality information on the diseases often results in a delay in diagnosis. Moreover, for many of them there is not an efficacious treatment. This often results in heavy social and financial burdens on patients and their families. Nevertheless, enormous progresses have been made in the last years thanks to the international cooperation in the field of clinical and scientific research as well as to the sharing of scientific knowledge about all rare diseases. Therefore, it is important to continue along this pathway to further support rare disease patients and their families. To this aim, the Rare Disease Day has taken place every year since 2008, to call upon researchers, universities, students, companies, policy makers and clinicians to do more research and to make them aware of the importance of research for the rare disease community. For this tenth edition of the Rare Disease Day, a special attention will be paid to the crucial role that patients play in research. Several initiatives have been, indeed, carried out over the last years with the scope to sensitize the clinical world and encourage the patient involvement in [...]
In October 2017, the European Reference Network for rare diseases of the respiratory system (ERN-LUNG) won the competition for a grant from the European Union to establish registries of patient data and make them fully interoperable with the already existing registries. ERN-LUNG represents the network of European healthcare providers dedicated to ensuring and promoting excellence in care and research for the benefit of patients affected by rare respiratory diseases. On December 15th, 2016 the European Reference Network Board of Member States approved ERN-LUNG as one of the 23 ERNs (European Reference Networks) for rare diseases. ERN-LUNG is currently made up of 60 centers in 12 Countries and is organized into nice core networks, representing the diversity of diseases and conditions affecting the respiratory system. Thanks to this European grant, ERN-LUNG proposed to build a comprehensive infrastructure that allows patient data management. This is just one of the many initiatives that ERN-LUNG is undertaking, with that aim to support patients and medical community in the challenge of the respiratory rare diseases treatment. For further information click here.
ID-EPTRI a new research infrastructure that will facilitate the future development of better paediatric medicines
Roma, January 2018 - ID-EPTRI (European Paediatric Translational Research Infrastructure) is a project coordinated by Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF-TEDDY) that granted with 3 million of Euros from funding of the European Commission. The main objective of the project lasting 24 months, is to design the framework for a new European Paediatric Research Infrastructure (RI). Minors represent 20% of the European population and their care is one of the most important priorities and challenges for Europe. It’s essential the development of evidence-based paediatric medicines and treatment strategies. Nowadays around the 50% of the medicines addressed to children and young patients have not been tested specifically for them. For this reason, it’s strategic the development of the suitable research infrastructure that can solve this problem, studying the paediatric research from the early phases to the paediatric formulation. Children and young patients cannot be never compared with adults as they are growing up and their metabolism is different. For this reason, the only way to develop better medicines for children and young patients is studying them specifically for this type of “special” population. A dedicated infrastructure integrating the different basic research networks addressed to paediatric population will help in the process to reduce time and increase the number of projects. On the other hand, it also can help to a fast translation into the clinical practice. This new research infrastructure, EPTRI is complementary to the other existing Biomed Research Infrastructures acting as a ‘Paediatric Common Service’ in the ESFRI (European Strategy Forum on Research Infrastructures) Scenario. The project involves 26 partners (listed in the Appendix 1) from EU and non-EU countries including consolidated research infrastructures, top-level universities, scientific and clinical centers of excellence in Europe and aims [...]
The Italian Medicines Agency (AIFA) announced the conclusion of the double-stage selection process for the AIFA 2016 call. Among the 343 clinical protocols submitted and considered eligible, 40 projects have been approved for a total value of funding of € 31,294,724. CVBF will take part to 2 of the funded clinical studies. […]
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. […]