Program - Presentations
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| The Belgian Association of Phase 1 Units (BAPU) has great pleasure in inviting you to its 3rd biannual symposium on early clinical drug development. The meeting deals with hot topics of general interest for people working in early drug development as well as with topics of particular interest for Belgium. You are also kindly invited to the reception following the meeting. |
PROGRAM
| 13.30u – 14.00u |
Welcome, Coffee |
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| 14.00u - 14.10u |
Introduction
L. Van Bortel |
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| CHAIR |
A. Dupont, O. Van Schoor |
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| 14.10u – 14.30u |
Early clinical development studies; recent trends and current status in Belgium and Europe
G. Musch (FAMHP, Belgium) |
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| 14.30u – 14.50u |
Implementation of GMP in Phase-I studies: the Belgian proposal
W. Janssens (FAMHP, Belgium) |
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| 14.50u – 15.10u |
Measures for meeting quality standards in Phase I studies
L. Van Bortel (Gent, Belgium) |
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| 15.10u – 15.25u |
Discussion |
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| 15.25u – 15.55u |
Coffee break |
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| CHAIR |
A. Peremans, T. Janssen |
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| 15.55u – 16.15u |
Calculation of safe starting dose and dose escalation in FTIM studies, the MABEL concept
B. Laurijssens (BEL Pharm Consulting, France) |
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| 16.15u - 16.35u |
Specific challenges in human pharmacology trials with biologicals
W. Greb (Neuss, Germany) |
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| 16.35u – 16.45u |
Belgian Association of Phase I Units: quo vadis?
J. de Hoon (Leuven, Belgium) |
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| 16.45u – 17.00u |
Discussion |
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| 17.00u |
Reception |
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