The DEEP project has received research funding from the European Union under the 7th Framework Programme
Presentations
VII DEEP Project General Assembly, Padua, 13 – 15 April, 2016
April 13th, 2016
SESSION I
- Project’s advancement up to the third DEEP report by Adriana Ceci
- DEEP-2 clinical trial conduction and post-trial evaluations by Aurelio Maggio
- Long-term DEEP 3 study results to increase deferiprone post-marketing evidence by Rosa Padula
- Pharmacoeconomic and HTA report of iron overload treatment options: the research questions by Fedele Bonifazi
SESSION II
- Ensuring maximum value from the DEEP program – (1) Financial support, (2) – The Path to Marketing Authorisation by John Connelly
- Activities workflow and budgeting to the end of the Project and related amendments to the Grant Agreement and the Consortium Agreement by Donato Bonifazi
April 14th, 2016
SESSION III
- DEEP-2 Study Protocol, Study Manual and Checklists by Silvia Morgagni
- IMPs safe reception, handling and disposal by Beatrice Pantaleo
SESSION V
- Patients on-going and study timeline by Donato Bonifazi
- e-CRF population and key points by Beatrice Pantaleo
- Relation between serum ferritin and heart MRI T2* in beta thalassaemia major patients by E. D. Gotsis
- Information documents and children assent: QuBo observational study by Florentia Kurti
SESSION VI
- DEEP-2 Monitoring plan, source data verification, investigator folder and patients files by Silvia Morgagni
April 15th, 2016
SCIENTIFIC OPEN MEETING
CHALLENGES AND OPPORTUNITIES OF CONDUCTING CLINICAL TRIALS IN PAEDIATRICS
- Clinical research: where are we now with the new CT Regulation by Hugo Devlieger
- Challenges and new opportunities of cooperation with the Mediterranean countries in the field of paediatric clinical research by Amal El-Beshlawy
- The Ethical issues in EU and non EU countries by Viviana Giannuzzi
- Global initiatives for paediatric research: the path to the European Paediatric Clinical Trials Research Infrastructure (EPCTRI) setup by Donato Bonifazi
- The role of Networks in fostering clinical research: expectations and needs by Carlo Giaquinto
MANAGEMENT OF THALASSAEMIA AND HAEMOGLOBINOPATHIES: AN ONGOING CHALLENGE
- Deferiprone investigational pathway: beyond thalassaemia and haemoglobinopathies by Michael Spino
- Model-based evaluation of benefit-risk balance in chronic iron overload in children by Oscar Della Pasqua
- Treatment and care organisation for SCD: a new challenge in Europe by Paul Telfer
- Patients Registries at National and International level by Alessia Pepe, Antonella Meloni
- The relevance of genetic prevention for Haemoglobinopathies by Marina Kleanthous
- Steps towards an international Network in Paediatric Haematology by Adriana Ceci
VI DEEP Project General Assembly, Tirana, 18 – 20 May 2015
May 18th, 2015
SESSION I
- DEEP-1 trial conduction and results by Giovanni Carlo Del Vecchio (PB)
- Comparison of results with existing data by Michael Spino (ApoPharma)
- Model-based evaluation of chelation therapy by Oscar Della Pasqua (UL)
- Planning the PK Evaluation in the DEEP-2 clinical trial by Beatrice Pantaleo (CVBF)
SESSION II
- DEEP-2 Statistical Plan by Paola Baiardi (CVBF)
- Report on current and future market and budget impact by Fedele Bonifazi (FGB)
- Pharmacoeconomics and HTA report by Pietro Folino Gallo (FGB)
May 19th, 2015
SESSION V
- Study population: 344 patients to ensure evaluation of 310 patients by Aurelio Maggio (AORC)
- Research in younger patients and other issues in Cyprus by George Papanikolaou (EB Member)
- How to export blood samples from Egypt by L. Ragab (EB Member)
- Material and procedure for the information consent and assent in UK by Hugo Devlieger EB Member)
- Supply of deferiprone 80 mg/ml after the DEEP-2 trial: regulatory and ethical aspects by John Connelly (Apotex)
SESSION VI
- DEEP-2 Study Protocol and the experience of Italian centres by Maddalena Casale (CVBF)
- DEEP-2 Study in Egypt by Mona El-Tagui (CU)
- DEEP-2 Study in Greece by Antonis Kattamis (NKUA)
- DEEP-2 Study in Cyprus by Soteroula Christou (CMoH)
- DEEP-2 Study in Turkey by Corinne Aad Naba’ (ClinServ International, Subcontractor CVBF)
SESSION VII
- Assuring Clinical Research Quality by Silvia Morgagni (Bioikos Farma, Subcontractor CVBF)
- Patient recruitment plan: critical point for the success of the clinical trial by Donato Bonifazi (CVBF)
- The FERRISCAN Protocol for the Evaluation of Liver and Cardiac Hemosiderosis used for the DEEP II Project by Sthatis Gotsis (Euromedica, Subcontractor NKUA and UHCT)
- First feedback on the subjects safety from DSMC by Slaheddine Fattoum (DSMC Member)
- Overview on the study: progresses and open issues by Adriana Ceci (CVBF)
SESSION VIII
- Structure and content of site visit reports/Document collection and transmission to TMF responsible/Handling of critical issues by Silvia Morgagni (Bioikos Farma, Subcontractor CVBF)
May 20th, 2015
SESSION IX
- Overview on DEEP-3: progresses and open issues by Mariagrazia Felisi (CVBF)
- ADR Assessment by Sebastian Botzenhardt (UKER)
- Updates from Cairo: More than one hundred patients evaluated by Mona Ghamrawy (CU)
SESSION X
- Towards the review of the project committed by the EC: next steps and timelines by Adriana Ceci (CVBF)
- A critical evaluation of the deliverables submitted by Maddalena Casale (CVBF)
- Dissemination of the project results by Mariangela Lupo (FGB)
- New budget approval by Donato Bonifazi (CVBF)
DEEP Project General Assembly, Athens, 5 July 2014
• Combined chelation therapy by Aurelio Maggio (AORC)
• Paediatric medicines and funds for paediatric research in the EU by Adriana Ceci (CVBF)
• Ferriprox today by Fernando Tricta (ApoPharma)
• New drugs for HCV treatment by Dimitrios A. Kountouras (MITERA Hospital)
• Clinical Research-where are we with the new RC trial Regulation by Hugo Devlieger (DEEP Ethics Board member)
• Patients empowerment and patients needs by Angelo Loris Brunetta (Fondazione Italiana “Leonardo Giambrone”)
• The emerging issue of SCD by Paul Telfer (Barts Health NHS Trust)
• MRI Analysis of the relaxation data and hidden surprises by Stathis D. Gotsis (EUROMEDICA-Encephalos, Halandri)
Sicilian Network for Thalassemia Meeting, Caltanissetta, 3 March 2014
• DEEP Project Presentation by Donato Bonifazi (CVBF), Aurelio Maggio (AORC), Lorella Pitrolo (AORC)
Meeting EuroMed Common Challenges (Regional Conference), Cairo, 9 February 2014
• FP7 Health Program supporting paediatric initiative: the DEEP multinational and multicultural experience by Adriana Ceci (CVBF)
5th European Symposium on Rare Anaemias, Ferrara, 15-16 November, 2013
• FP7 Projects in Rare Anaemias: DEEP – Deferiprone Evaluation in Paediatrics by Adriana Ceci (CVBF)
13th International Conference on Thalassemia (TIF 2013 World Congress), Abu Dhabi, 20-23 October 2013
• The DEEP Project by Evi Missouri Khetab (CMoH)
• A multi-ethnic multi-national approach to ethical approval of clinical trials involving Thalassaemia patients: the DEEP lesson by Adriana Ceci (CVBF)
• Iron Chelation Therapy in Pediatrics Patients by Antonis Kattamis (NKUA)
