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Training Days 2009New Drugs Development
in Paediatric Oncology
ITCC Educational Task Force …
Hubertus N. Caron
François Doz
Darren Hargrave
Riccardo Riccardi Chairman
Gilles Vassal
Faculty …
Joachim Boos Münster, DE
Renaud Capdeville Basel, CH
Dominique Couanet Villejuif, FR
Hubertus N. Caron Amsterdam, NL
François Doz Paris, FR
Birgit Geoerger Villejuif, FR
• ITCC, European no-profit Consortium, is pleased to announcethe 2nd ITCC Training Course devoted to early drugdevelopment in paediatric patients with cancer.
• This course is a clinically-oriented educationalprogramme designed for paediatric oncologists who wish toimprove their skills in the conduct of early clinical trials.
• The course offers plenary lectures on state-of-the-artand practical workshop sessions
• It is addressed to doctors and research nurses working inITCC centres. However motivated paediatric oncologists fromother institutions, including personnel from pharmaceuticalcompanies, may apply.
• 40 participants will be admitted. Selection will be madeon the basis of personal CV (visit www.ptsroma.it/itcc2009)
Course VenueCatholic University of Rome
Largo A. Gemelli 8, 00168 Rome, ItalyRoom “Brasca”, Floor 4
Registration to the CourseRegistration fees
€ 500,00 + 20% VAT for academiain Paediatric Oncologya Post Graduate Course
October 22-24, 2009Catholic University, Rome, Italy
Birgit Geoerger Villejuif, FR
Darren Hargrave Sutton, UK
Janez Jazbec Ljubljana, SL
Pamela Kearnes Bristol, UK
Marie Cécile Le Deley Villejuif, FR
Bruce Morland Birmingham, UK
Herbert Newell London, UK
Kathy Pritchard-Jones Sutton, UK
Riccardo Riccardi Roma, IT
Gilles Vassal Villejuif, FR
Gareth Veal Newcastle upon Tyne, UK
Arnaud Verschurr Amsterdam, NL
Louis Viviers Basel, CH
Acknowledgements
€ 500,00 + 20% VAT for academia€ 1500,00 + 20% VAT for non academic applications
VAT is compulsory for EU citizens
Registration fee includes• Attendance in the scientific sessions•Coffee breaks and working lunches
• 3 nights hotel accomodationCancellation.
No refund allowed. name change is permittedprior to October 1, 2009
Organizing Secretariat
PTS Congress – Maura Stella
Via Nizza, 45 – 00198 Roma (Italy)
Phone: +39-06-8535-5590
Fax: +39-06-8535-6060
e-mail: [email protected]
Course Secretariat
Sara Calmanti
Sonia Terella
Mirella Oddi
22 OctoberChair: R. Riccardi
16.00-16.10 Welcome R. Riccardi
16.10-17.00 Lecture Strategy for thedevelopment of theInnovative Therapiesfor Children withCancer
G. Vassal
17.00-18.00 Lecture Role of biology andpreclinical evaluation
H. Caron
ITCC Training Course: New Drugs Development in Paediatric Oncology
S c i e n t i f i c P r o g r a m m e
23 OctoberChair: D. Hargrave
08.30-09.30 Lecture Design and conductof phase I studies:from MTD to OBD
B. Geoerger
09.30-10.30 Lecture Coordination ofpharmacokineticsstudies in apaediatric patientpopulation
G. Veal
10.30-11.00 Coffee break
11.00-13.00 WorkshopGroupSession
Protocoldevelopment: phase Itrials
D. HargraveB. GeoergerA. Verschuur
13.00-14.00 Lunch
24 OctoberChair: B. Morland
08.00-08.30 Keynote Introducing innovativetherapies in thestandard care ofchildren with cancer inEurope
K. PritchardJones
08.30-09.15 Lecture How to conduct aphase II trial
B. Morland
9.15-9.45 Lecture Early clinical studies inleukaemia
P. Kearnes
09.45-10.30 Keynote Biomarkers inanticancer drugdevelopment
H. Newell
10.30-11.00 Coffee break
11.00-13.00 WorkshopGroupSession
Protocol development:phase II trials
B. MorlandP. KearnesF. Doz
13.00-14.30 Lunch
preclinical evaluationin anticancer drugdevelopment forchildren
18.00-19.00 Keynote Role of paediatricinvestigational plans innew drug development
J. Jazbec
Chair: F. Doz
14.00-14.45 Lecture Pharmacovigilancein paediatriconcology trials
J. Boos
14.45-16.30 Interactivesession
How to propose anearly clinical trial topatients and parents
F. DozR. Riccardi
16.30-17.00 Coffee break
17.00-17.45
17.45-18.30
Workshop
Keynote
New design andmethodology forearly clinical trials inchildren
Integration of clinicalresearch and drugdevelopment
M.C. Le Deley
R. Capdeville
Chair: G. Vassal
14.30-15.30 Keynote Comprehensiveimaging in paediatriconcology: use of righttools for innovativetreatment
D. Couanet
15.30-16.15 Interactivesession
Case studies: tumourresponsemeasurement
D. CouanetR. RiccardiD. Hargrave
16.15-16.45 Coffee break
16.45-17.15 Keynote Academia-Pharmacollaboration inpaediatric oncology
L. Viviers
17.15-18.00 Paneldiscussionwith theparticipants
Partnership inbetweenPharma-Regulators-Academia
L. ViviersH. NewellG. Vassal