News & Events

16th May 2019. Presentation of the final Document of the Consultation on civic participation in healthcare system. The KIDS Bari contribution

The final event of the project "Consultation on civic participation in healthcare system", promoted by Cittadinanzattiva with the non-conditioning contribution of Novartis, was held on 16th May, 2019 in Rome at “Sala Igea – Treccani”. The consultation process took place on 30th and 31th January ,2019 at the Luiss EnLabs, involved 100 health stakeholders and resulted in the release of a final Document and presented during the final event in May. The result of this work was the sharing of a “Matrix for the quality of participatory practices” which, starting from the identification of risks and appropriate actions to minimize them, aims to become a useful tool for public  institutions to shape their participatory practices in public health policies and ensure an effective involvement of citizens. Many experts worked on the drafting of the document, including representatives of institutions and health professionals, researchers, experts and citizens. Mariangela Lupo, Team Leader of KIDS Bari, the first Italian YPAG (Young Persons Advisory Group), and Antonio Di Pietro, one of the young members of KIDS Bari, were among the collaborators who reviewed and developed the document, providing useful insights for the analysis of participatory practices in healthcare system, such as the need to encourage and guarantee the continuous and adequate training of personnel. In this regard, the document highlighted and suggested the e-learning course "ICH-Good Clinical Practice (GCP)", promoted by Consorzio per Valutazioni Biologiche e Farmacologiche and designed to provide a guide for all the professionals involved in clinical research and trials clinicians. Likewise, patient’s involvement and in particular children engagement in the clinical process should be a fundamental practice, needed to maintain the trust of stakeholders and citizens. In this regard, the role of TEDDY European Network [...]

2019-06-11T08:23:12+00:00 11/06/2019|Categories: News & Events|

CVBF – New positions opened

New positions are opening for experienced CRAs located all over Europe, to conduct monitoring activities in the context of two multinational paediatric studies. To apply click here.

2019-06-07T10:27:38+00:00 05/06/2019|Categories: News & Events|

Donato Bonifazi speaker al Carpathian Research Group Training Event a Kiev

On 20th April 2019 the “CRGroupe Academy” training event, organised by the Carpathian research Group, took place in Kiev (Ukraine). Donato Bonifazi, Chief Executive Officer at Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF), participated in the event as speaker, providing a presentation on ICH – Good Clinical Practice (GCP). He presented the basic principles of GCP and main responsibilities of the investigators dealing with clinical trials. The discussion was mainly focused on the information provided in the chapter 4 of ICH GCP guidelines, describing the main tasks and procedures that each investigator has to manage. Particular attention was given to the paediatric aspects and the procedures of patients engagement in clinical research. Headquartered in Ukraine Carpathian Research Group LLC is a privately-owned clinical research organization (CRO) supporting broad range of R&D activities for biopharmaceutical and medical device industry across Ukraine and neighbouring countries (including, but not limited to Georgia, Moldova, Turkey, Romania, Bulgaria, Kazakhstan, Uzbekistan and Belarus). For more information please click here.

2019-05-07T08:03:33+00:00 07/05/2019|Categories: News & Events|

SAVE THE DATE: “Pharmacovigilance: common assessment tools and Promoter responsibility – 25 June 2019, Rome

On 25 June 2019, a workshop entitled “ Pharmacovigilance: common assessment tools and Promoter responsibility” will be held at University Polyclinic “Agostino Gemelli” in Rome. Dr. Mariagrazia Felisi, Clinical Research Director at Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF) will be one of the relator of the training event that will provide an update on the current pharmacovigilance legal obligations in the field of clinical research and networking moment with professionals of the sectors, in order to share the common tools available to properly assess the Pharmacovigilance (PV) activities. The workshop will foresee the following sessions: Regulatory overview and required documentation Management of reports in Eudravigilance The company experience: from the interventional studies to the requirements for the observational studies Experience in no-profit studies Practical exercise: building a pharmacovigilance estimate The workshop is addressed to all the professional figures operating in clinical research field, in particular Senior CRAs, Clinical Team Leaders, Lead CRAs and Clinical Project Managers, researchers. The workshop is organised by AICRO (Associazione Italiana Contract Research Organization) within its institutional aims to promote high quality standard clinical trials as well as to provide training for the professionals involved in the clinical research. More information about the workshop and the registration process, click here.

2019-05-31T11:12:03+00:00 03/05/2019|Categories: News & Events, Sticky|

8 May 2019: International Thalassaemia Day

Even this year the International Thalassaemia Day will be celebrated on 8 May 2019, in honour of all patients with thalassaemia and their parents with the aim to raise awareness on this disease.  Despite the progress that has been attained in over the past decades, millions of people still lack physical or financial access to free-of-charge quality thalassaemia healthcare services. In occasion of this event, the Thalassaemia International Federation (TIF) has organised 3 online competitions (a video challenge, a photography contest, and a story challenge), inviting the global thalassaemia community to submit videos, stories and photographs (or collages). The International Thalassaemia Day 2019 will be the occasion to discuss also the importance of the ad hoc studies in paediatric populations for the development of drugs specific for children affected by Thalassaemia. Consorzio per Valutazione Biologiche e Farmacologiche (CVBF), as DEEP (DEferiprone Evaluation in Paediatrics) Coordinator, strongly supports this initiative and keeps on being proactive in promoting the research in the field of Thalassaemia. DEEP (DEferiprone Evaluation in Paediatrics) was a 6-year European project funded by the European Union’s 7th Framework Programme for Research and Technological Development, with the aim to study the efficacy and safety of deferiprone (the first oral iron chelators developed in Europe) in children affected by β-thalaessemia major and other transfusion dependent haemoglobinopathies. In particular, the Project included three studies aimed to evaluate the pharmacokinetics (DEEP-1 study), efficacy/safety (DEEP-2 study) and long-term safety (DEEP-3 study) of deferiprone in this specific patient population, in accordance with the Paediatric Investigation Plan (PIP) approved by the EMA Paediatric Committee (PDCO). The research activities involved 16 European and non-European partners (including hospital centres, universities, companies and research associations) and comprise 23 recruiting centres in EU (Cyprus, [...]

2019-05-03T09:25:34+00:00 02/05/2019|Categories: News & Events|

Drug Discovery and Development – “Challenges and New Frontiers in the Paediatric Drug Discovery and Development” – the chapter is online!

A chapter dedicated to the future perspectives  of the paediatric drug discovery and development and  written by the experts from Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF) and TEDDY – European Netwrok of Excellence for Paediatric Clinical Research, Angelica Intini, Donato Bonifazi and Giovanni Migliaccio, has just been published on-line and will be included in the book entitled “Drug Discovery and Development - New Advances”, published by IntechOpen, one of the world’s leading publisher of open access books. The chapter, entitled “Challenges and New Frontiers in the Paediatric Drug Discovery and Development”, provides an overview on the drug discovery and development path for children highlighting challenges and new frontiers of each phase from the discovery to the preclinical and clinical development as well as we will provide a slightest hint about paediatric biomarkers discovery, age-appropriate formulation, pregnancy, and perinatal pharmacology and in silico pharmacology. Drug discovery and development path represents the long process starting with the identification of new target molecules (discovery phase), going through studies on microorganisms and animals (preclinical development) and finally testing the new medicines in the target population (clinical development) to bring them to the market (authorization and commercialization). As the author have strongly underlined, paediatricians routinely give drugs to children ‘off-label’ (drug not specifically approved for use in children), although it is known that children respond to drugs in a very different way than adults in terms of safety and efficacy, so that a new drug to be used in children should be specifically tested in children themselves in controlled clinical studies. The gap in the availability of proper medicines for children can be traced back to ethical, practical and economic reasons. Many initiatives have been taken over the years, [...]

2019-04-30T11:07:39+00:00 15/04/2019|Categories: News & Events|

SAVE THE DATE. 17 April – EUCROF Webinar “Doing More with Data: Data Anonymisation and Pseudonymisation under the GDPR”

Registrations are still open for the new EUCROF webinar “Doing More with Data: Data Anonymisation and Pseudonymisation under the GDPR” that will take place on 17 April 2019. The webinarwill describe pseudonymisation and anonymisation techniques, specifically for clinical trial data, and how these fit within the GDPR regulatory framework. Many organisations are trying to exploit more value from their data to improve their products and services as well as to offer new ones and optimise their own internal operations. With the General Data Protection Regulation (GDPR) in place, these organisations need to determine the lawful basis for such activities. De-identification techniques, such as pseudonymisation and anonymisation, can play an important role in facilitating such secondary uses and disclosures of data. The webinar will be held by Khaled El Emam Founder, General Manager, and President of Privacy Analytics and is organised within the Events&Training working group of EUCROF. This Working Group (WG) has been launched with the aim to strengthen both events and training in the light of the educational vocation of all the activities EUCROF offers to its associates and external stakeholders. Donato Bonifazi, Chief Executive Officer at Consorzio per Valutazioni Biologiche e Farmacologiche, is the chair of the WG that intends to deliver activities to build relationships across organisational boundaries as well as to give training staff the opportunity to develop skills, expertise and grow within their role. For more information about the webinar and for registrations, click here.

2019-04-15T09:24:44+00:00 15/04/2019|Categories: News & Events|

SAVE THE DATE: the 2nd Kiev Clinical Research Forum will take place on May 16-17

PharmaSich, CRO in Eastern Europe headquartered in Kiev, will organise the 2nd Kiev Clinical Research Forum that will take place on 16 – 17 May 2019 under the patronage of EUCROF. Martine Dehlinger-Kremer, President of EUCROF, and Sergii Myronenko. CEO at PharmaSich CRO, are part of the Organising Committee of the event, that will bring together international experts from pharmaceutical/biotech companies, CROs, academia and regulatory agencies. This edition will see the participation of over 60 speakers representing pharma companies, CROs and academia coming from Europe, US, Israel. Donato Bonifazi, Chief Executive Officer at Consorzio per Valutazioni Biologiche e Farmacologiche and chair of the EUCROF Events and Training Working Group will participate in the meeting as speaker, explaining the importance and the role of the research infrastructures on the current scenario of the preclinical and clinical research and the possibility of CRO partnerships in this context. The overall aim of the meeting will be to share views and knowledge on clinical research among all the participants, providing networking opportunities and an adequate discussion moment between speakers and audience. More information and the agenda of the meeting is available at this link.

2019-04-15T08:15:05+00:00 12/04/2019|Categories: News & Events|

#wecare_ye: a new project for CVBF

We are very pleased to announce that the #wecare_ye project, coordinated by CVBF and funded within the European Programme Erasmus+, started in January 2019 with the aim to foster youth active participation in the field of Health and Wellbeing and support actions for the promotion of youth groups exchange in Belgium, the Czech Republic, Greece and Romania, based on the model of what has been achieved with the first Italian and Albanian Young Persons Advisory Groups, respectively named KIDS Bari and KIDS Tirana. Within this project, the partner organizations have selected 5 people per country (25 participants in total), aged 13-18 years, chosen among youngsters involved in their local activities: young patients, patients' relatives, youngsters interested to health in general. Moreover, each national group will be supported by one group leader per country, preferably under 30 years, selected among staff members. These youngsters involved have expressed a common need to gain a better knowledge on Health issues, in order to better influence their social and political environment. The project will act on 3 levels - knowledge, empowerment, engagement. KIDS Bari and KIDS Albania, born in 2017, include youths (both patients and healthy teenagers) actively involved in the definition of key issues and questions in the paediatric research projects as well as in the communication and sensitization activities about the healthcare by consciously using the social networks. Since the launch of these initiatives, the members of KIDS Bari and KIDS Albania have been providing a fundamental support in advising researchers in a full range of international initiatives to promote paediatric drug development. More information is available here.

2019-04-15T08:09:00+00:00 12/04/2019|Categories: News & Events|

EMA: Regulatory information – adjusted fees for applications to EMA from 1 April 2019

General, non-pharmacovigilance fees payable to EMA by applicants and marketing-authorisation holders are increasing by 1.7% on 1 April 2019. Every year, the European Commission adopts a regulation adjusting the fees payable to the Agency with reference to the inflation rate in the European Union for the previous year. The 2018 inflation rate was 1.7%. Full details of the new fee levels are available in Commission Regulation (EU) No 2019/480 amending Council Regulation (EC) No 297/95, its implementing rules and the corresponding explanatory note on fees, published on 1 April 2019. These documents include the new fees for all types of procedures handled by the Agency, except for pharmacovigilance procedures. For annual fees, the anniversary date of the decision granting the marketing authorisation defines the applicable fee and consequently a new fee will be applicable at the time of any anniversary on or after 1 April 2019. In addition, access to SME incentives for regulatory consultancies has been clarified (human and veterinary medicines). Fees charged for pharmacovigilance procedures in accordance with Regulation (EU) 658/2014 are expected to be revised in 2020, taking into account the 2018 and 2019 inflation rates.

2019-04-15T08:07:17+00:00 12/04/2019|Categories: News & Events|