London, united kingdom
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- Bu səhifədəki naviqasiya:
- BDA PAEDIATRIC ONCOLOGY WORKSHOP IN COLLABORATION WITH ITCC AND ENCCA
- Programme Overview Monday 5 December 2011 09:30 - 18:30
- NEW ONCOLOGY DRuGS fOR CHILDREN AND ADOLESCENTS: WHERE ARE WE WHAT ARE THE ISSuES
- WRAP uP BREAKOuT SESSION 1
- 08:30 - 12:30 HOW SAfE IS THE DRuG
- WRAP uP SuMMARY AND PROPOSALS BREAKOuT SESSION 3 SuMMARY AND PROPOSALS BREAKOuT SESSION 4 CONCLuSION AND ACTION PLAN
- SANCO
| PROGRAMME LONDON, UNITED KINGDOM 5-6 DEcEMbEr 2011 LONDON, UNITED KINGDOM 5-6 DEcEMbEr 2011 www.bdaoncology.org Scientific Organising Committee
Meeting Venue Britannia International Hotel Canary Wharf 163 Marsh Wall London E14 9SJ United Kingdom Tel.: +44 (0) 207 712 0100 Fax: + 44 (0) 207 537 1938 www.britanniahotels.com/hotels/london Registration Fees Meeting Presenters from Academia, BDA Partner Companies & Regulators Free Parents & Representatives of Parent Organisations Free Academia and Regulators 250 EUR Industry 950 EUR Secretariat Hans Hendriks BDA Oncology Tel.: +31 299 413 005 E-mail: bdaoncology@kpnmail.nl For all programme updates, registration, travel and accommodation please visit www.bdaoncology.org Innovative Oncology Drug Development for Children and Adolescents in Europe: Current Status and Where to Go Innovative Oncology Drug Development for Children and Adolescents in Europe: Current Status and Where to Go BDA PAEDIATRIC ONCOLOGY WORKSHOP IN COLLABORATION WITH ITCC AND ENCCA LONDON, UNITED KINGDOM 5-6 DEcEMbEr 2011 There is a major need for new and effective oncology drugs for children and adolescents with cancer that will not only increase their chances of survival but also their quality of life. The objective of the European Union Paediatric Regulation, introduced in January 2007, was to improve the health of children in Europe by: Facilitating the development and availability of medicines for children aged 0 to 17 years; Ensuring that medicines for use in children are of high quality, ethically researched and authorised appropriately; Improving the availability of information on the use of medicines for children. In 2011, ENCCA, an EU-funded Network of Excellence, was launched to structure clinical and translation research in paediatric and adolescent oncology in Europe. This Workshop will: share recent advances in the field of paediatric oncology; evaluate the impact of the EU and US regulations on paediatric oncology; propose solutions to identified bottlenecks and hurdles. All stakeholders will participate: Academia, Parents and Patients, Pharma Industry, European Medicine Agency, EMA Paediatric Committee, Government bodies and Members of the European Parliament. The goal of the meeting is to provide an action plan in order to increase the likelihood that children and adolescents with cancer will benefit from both the EU Paediatric Medicine Regulation and EU funded structuring activities. The meeting will be published in European Journal of Cancer as a position paper. chaIrs Gilles Vassal Lothar Bergmann Ralf Herold spEaKErs Peter Adamson
Lesley Narburgh André Baruchel
Andy Pearson Jacqueline Carleer Agnès Saint Raymond Ralf Herold
Stephan Schwoch Lars Hjorth
Malcolm Smith Angela Howes
Henk van den Berg Stephanie Mondabon Gilles Vassal Additional speakers to be announced.
WELcOME aND INTrODUcTION frOM ThE chaIr: GILLEs VassaL SETTING uP THE LANDSCAPE − The Need for Innovative Therapies for Children and Adolescents with Cancer − Developing Oncology Drugs in Adults in the Era of Personalised Medicine − Approving Oncology Drugs in the Era of Personalised Medicine NEW ONCOLOGY DRuGS fOR CHILDREN AND ADOLESCENTS: WHERE ARE WE? WHAT ARE THE ISSuES? − The Impact of the EU and US Regulatory Initiatives − Roundtable Discussion with representatives of EMA, PDCO, DG SANCO, Industry, Academia, Policymakers & Parents LUNch
paraLLEL brEaK OUT sEssIONs brEaKOUT sEssION 1 How to Improve Early Access to Innovative Drugs to Meet the Needs of Children and Adolescents in Europe brEaKOUT sEssION 2 How to Prioritise Oncology Compounds for Development in Children and Adolescents with Cancer
− The Strategy for New Drug Development by Disease − Integrating Paediatric Oncology Drug Development in the Strategy of Pharmaceutical Companies − Summary & Proposals BREAKOuT SESSION 2 − The PPTP and TARGET NCI Initiatives − The KidsCancerKinome Project − Summary & Proposals rEcEpTION
− Handling Early Non-Clinical and Clinical Safety Signals − Industry Perspective paraLLEL brEaKOUT sEssIONs brEaKOUT sEssION 3 How to Set up Long-Term Follow up of Children and Adolescents Exposed to New Drugs and Make it Available for all Stakeholders brEaKOUT sEssION 4 How to Facilitate Cooperation and Collaboration Between all Stakeholders WRAP uP SuMMARY AND PROPOSALS BREAKOuT SESSION 3 SuMMARY AND PROPOSALS BREAKOuT SESSION 4 CONCLuSION AND ACTION PLAN LUNch
BDA, Biotherapy Development Association (www.bdaoncology.net/); CHMP, Committee for Medicinal Products for Human Use; COG, Children’s Oncology Group; DG SANCO, EC Directorate General Health and Consumers; EMA, European Medicine Agency (www.ema.europa.eu); ENCCA, European Network for Cancer research in Children and Adolescents; ITCC, network for Innovative Therapies for Children with Cancer (www.itcc-consortium.org); MEP, Member of the European Parliament; PDCO, Paediatric Committee; PIP, Paediatric Investigation Plan; PPTP, Paediatric Preclinical Testing Programme Yüklə 224,67 Kb. Dostları ilə paylaş:
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