| Sunday, September 7 |
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| Registration desk open, 13.00 hr Hotel Okura |
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12.00 - 15.00
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Executive Committee IFAPP
Okura Hotel |
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15.00 - 16.00
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House of Delegates IFAPP
Okura Hotel |
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| 19.00 |
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Opening Ceremony ICPM 2008
Welcome Reception
Rijksmuseum Amsterdam
Kick off lectures:
- Building trust in Medicines - Kees van Grootheest, Netherlands Pharmacovigilance Centre
- Building trust in Pharmaceutical Industry - Rien Meijerink, Dutch Council for Public Health and Health Care
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| Monday, September 8 |
| Developing Pharmaceutical Care |
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Morning plenary program
09.00 - 10.30
11.00 - 12.30
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State of the Art in Translational Medicine
Chairs: Gustavo Kesselring, Joop van Gerven
- Physiology based modelling - Meindert Danhof, LACDR
- From bedside to bench - Andreas Wallnöfer, F. Hoffmann-La Roche Ltd.
- New translational models - Philip Scheltens, VU University Medical Center
State of the Art in Trial Design Technology
Chairs: Gerfried Nell, Paul de Koning
- Predictive utility of biomarkers, surrogate endpoints, role in decission making during development - Paul Rolan, The University of Adelaide
- Pharmacogenomics in trial design - Kevin Cheeseman, AstraZeneca
- Adaptive clinical trial design: pro's and con's - Kit Roes, Organon, part of Schering-Plough
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Morning short course
09.00 - 12.30
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- Statistics for non-interventional studies - Richard Kay, RK Statistics
- Update in Risk-Benefit Analyses - Graeme Ladds, PharSafer Associates
- Media Training - Ingo Heijnen, Hill & Knowlton
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| 12.45 - 13.45 |
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Lunch Symposium Nefarma
Patient centred Drug Development
Chair: Wim Wientjens
- PatientPartner EU FP7 - Cor Oisterwijk, Dutch Genetic Alliance
- The relation between industry and patients organizations - Ria Broekgaarden, Association of musculoskeletal diseases Netherlands
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Afternoon parallel
14.00 - 15.30
16.00 - 17.30
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Medical Research after Marketing Authorisation
Chairs: Bertrand Baumelou, Martijn Torremans
- Non-interventional studies - Giovanni Fiori, MediData
- Anticipating reimbursement issues - Hubertus Rosery, AiM GmbH
- US-EU Regulations & safety registries - Hugo Stephenson, iGuard
Off-Label Pharmacotherapy
Chairs: Jane Barrett, Eric Hoedemaker
- Off-label pharmacotherapy: when evidence without label - Ton de Boer, Dept of Pharmaco-epidemiology and pharmacotherapy, University of Utrecht
- Off-label Rx: cheap evidence, payers perspective - Albert Wertheimer, Temple University / School of Pharmacy
- Off-label-comparator through the eyes of EMEA - Noel Wathion, EMEA
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Modern Clinical Development 1 Outsourcing Strategies
Chairs: Domenico Criscuolo, Philippa Smit-Marshall
- Models for Outsourcing in Clinical research - Jeffrey McMullen, PharmaNet Development Group
- Partnering with CROs, trends and opportunities - Rene Sluijter, Solvay Pharmaceuticals
- Outsourcing needs of Biotech vs those of Pharma - Gillian Langford, Alizyme Ltd.
Risk Assessment in Clinical Trials and Quality Issues
Chairs: Philip Salden, Tanja Hoffman
- Risk Assessment in Clinical Trials - Holger Liebig, Parexel
- Striving for Quality - Peter Schiemann, Roche
- Quality at any Cost - Rita Hattemer-Apostel, Verdandi AG
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| 17.30 - 18.30 |
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Networking Event |
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| 19.30 |
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IFAPP Presidents' Meeting
Okura Hotel |
| Tuesday, September 9 |
| Medicines after Blockbuster Era |
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Morning plenary program
09.00 - 10.30
Morning parallel program
11.00 - 12.30
Morning parallel program
11.00 - 12.00
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Highly Specialized Indications in Research
Paediatric research
Chairs: Martin Offringa, Gerard van Leijenhorst
- Essentials of pediatric drug development - John van den Anker, Children's National Medical Center
- Regulatory aspects of paediatric drug development - Agnès Saint-Raymond, EMEA
- The role of paediatric networks - Rosalind Smyth, University of Liverpool
Orphan World
Chairs: Norbert Clemens, Ad Sitsen
- Orphan drug Development in Europe - Sonja van Weely, Stearing Committee Orphan Drug Netherlands
- 25 yrs orphan drug development in US - Marlene Haffner, Amgen
- Hurdles in orphan drug development - Bruno Giannetti, Pharming Group NV
Medicines for Children Research Network; Official Launch
Chair: Martin Offringa
- Louise Gunning - Dutch Federation of University medical Centers - NFU
- Gerard van Leijenhorst - on behalf of the Dutch Pharmaceutical Industry
- Willem Fetter - Dutch Paediatric Society - NVK
- Jan Schellens - Dutch Society of Clinical Pharmacology & Biopharmacy - NVKF&B
- Cor Oosterwijk - VSOP Dutch Genetic Alliance
- Matthijs de Hoog - Dutch Paediatric Pharmacotherapy Network - NKFK
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Morning short course
09.00 - 12.30
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- Statistics for non-interventional studies - Richard Kay, RK Statistics
- Update in Risk-Benefit Analyses - Graeme Ladds, PharSafer Associates
- Media Training - Ingo Heijnen, Hill & Knowlton
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| 12.45 - 13.45 |
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Lunch Symposia
Medicines for Children Research Network; Meet the entities -
GlaxoSmithKline
- Coordinating Centre
- Clinical Study Groups
- Methodology Platforms
- Regional Research Clusters
- National Training Officer
- National Trial Support Unit / Information Management
- Industry Liaison
- International Standards for Research with Children Project
Risk Management: A Patient Centric Approach -
Quintiles
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- Saad Shakir, Drug Safety Research
Unit (DSRU)
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- Hugo Stephenson,
iGuard
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- Dipti Amin,
Quintiles
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Afternoon parallel
14.00 - 15.30
16.00 - 17.30
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Pharmaceutical Crisis Management
Chairs: Chris Allen, Rudolf van Olden
- Role of Drug Safety Monitoring Boards - Karin Hedenmalm, CTU Medical Products Agency
- Case report: Pre-Approval - Probiotica - Geert Blijham, University Medical Center Utrecht
- Case Report: Post Approval - Glitazones, Alastair Benbow, GlaxoSmithKline
Getting new therapeutic modalities to the market
Chairs: Luis Collia, Ed Schook
- Regulatory hurdle, need for change? - Bert Leufkens, CBG-MEB NL
- Reimbursement hurdle, need for change? - Sir Michael Rawlins, NICE UK
- Ethical hurdle, need for change? - Greg Koski, Academy of Pharmaceutical Physicians and Investigators
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Modern Clinical Development 2
Trends in Clinical Development
Chairs: Johanna Schenk, Tanja Hoffman
- Stimulating Innovation: conditional and accelerated approach - Richard Tiner, Association of the British Pharmaceutical Industry
- Patient Recruitment Strategies: Differences between Ph II/III - IV - Tom Ruane, Quintiles
- Post marketing surveillance: Registries and other techniques - Annalisa Rubino, Outcome
Managing Cost Aspects in Clinical Development
Chairs: Jean-Paul Deslypère, Philippa Smit-Marshall
- Cost management and Performance Metrics - Ross Elgar, Pfizer Global Research and Development
- The use of e-Clinical processes in improving cost efficiencies - Udo Siegmann, Parexel International
- Improved efficiencies: clinical trials in the Asia/Pacific triangle - Jean-Paul Deslypère - APP Singapore
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| 17.30- 18.30 |
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Networking Event |
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| 19.30 |
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Gala Dinner and IFAPP lecture - Patrick Dixon, Global Change Ltd
Beurs van Berlage |
| Wednesday, September 10 |
| Pharmaceutical Future |
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| 09.00 - 14.00 |
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Any end of the Blockbuster Mindset
Chairs: Stewart Geary, Henk-Jan Out
- R&D philosophy: private-public partnerships - Daan Crommelin, Dutch Top Institute Pharma
- Targeted therapies: nichebusters, Erik Tambuyzer, Genzyme
- Drivers behind science: role of financial investor - Martin Eij
- genhuijsen, APG Investments
Scientific Drivers behind Pharmaceutical Medicine
Chairs: Sander Becker, Montse Barceló
- Stem cell Research; New Panacea? - Gabriel Márquez - Genetrix
- Latest Developments in Pharmaceutical Nanotechnology - Alexander Florence, The School of Pharmacy, University of London
- Personalized medicine: driver behind the end of the blockbuster era? - Michael Liebman, Strategic Medicine
Closing Ceremony
ICPM 2010 at a glance
FARE WELL LUNCH
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| Scientific Committee |
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| Joop van Gerven |
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CHDR |
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| Marlène Hoynck van Papendrecht |
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Centocor |
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| Tanja Hoffman |
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Quintiles |
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| Paul de Koning |
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Astellas |
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| Gerard van Leijenhorst |
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Merck Sharp & Dohme |
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| Paul van Meurs |
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Bio-Imaging Technologies |
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| Rudolf van Olden |
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GlaxoSmithKline |
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| Henk-Jan Out |
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Organon International |
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| Philip Salden |
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AstraZeneca |
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| Ad Sitsen |
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ClinPharMed |
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| Ed Schook |
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Nycomed |
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| Ron Suijkerbuijk |
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Amgen |
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| Martijn Torreman |
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Janssen-Cilag |
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| Philippa Smit-Marshall |
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PharmaNet |
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| Eric Hoedemaker |
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sanofi-aventis |
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