Präsentationen 2011
Godfrey, E.
Godfrey Elaine.pdf(66 kB)
The role and responsibilities of a national competent authority in the development of modern therapies
Flory, E.
Session2 Egbert Flory.pdf(1.6 MB)
EMA’s role and responsibilities for the development of modern therapies
Hammond, M.
Hammond Mike – VaccineFin.pdf(119 kB)
Early clinical development of vaccines
Laurijssens, B.
Modelling and simulation to help Mabel defination-.pdf(2.2 MB)
Modelling and simulation to help Mabel defination – Introduction: The MABEL contest
L’Hostis, P.
L Hostis Philippe – QT Studies for Biologics 31MAR2011 PLH-Biotrial.pdf(250 kB)
QT-Studies for biologicals
Lorch, U.
Lorch Ulrike Phase 1 Accreditation.pdf(1.7 MB)
Need for a uniform European registration system for Phase I units?
Lloyd, P.
Lloyd Peter – 4 Biologics vs NCE .pdf(1.1 MB)
Biologicals vs. small molecules – What's the difference?
Martin, S.
Modelling and simulation to help define Mabel 02.pdf(1.2 MB)
Modelling and simulation to help define Mabel – and Starting dose in FIH studies
Narayanan, G.
WS4 G Narayanan.pdf(91 kB)
Biologicals vs. small molecules – What’s the difference?
Patat, A / Donazzolo, Y.
Patat Alain Yes Donazzolo Stopping Rules APA BERLIN 2 .pdf(527 kB)
Stopping rules in exploratory drug development
Patat, A.
Patat Alain Yves Donazzolo – SAE 2004-2010.pdf(84 kB)
Need for SAE-reporting in Phase I studies across countries?Patat Alain – CPU Accreditation AGAHCPI Berlin.pdf(48 kB)
Accreditation of Phase I units and protection of subjects participating in clinical trials in France
Peeters, M.
Peeters Mathieu – Joint Conference of European Human Pharmacological Societies Berlin March 2011 Final version.pdf(3.3 MB)
Early clinical development of vaccines
Peremans, A.
Sessios5 Presentation A Peremans pdf.pdf(7.2 MB)
Need for a uniform European registration system for volunteer participation?
Plassmann, S.
Session1 Plassmann .pdf(2.1 MB)
Impact of the ICH-M3 guideline on the early development of biologicals
Schug, B.
Schug Praesentation final corr2.pdf(782 kB)
Example for an early drug-device development plan
Täubel, J.
Taeubel QT Studies for Biologics Workshop 2.pdf(571 kB)
QT Studies for Biologics
Tiedemann, G. / Sawatzky, D.
WS 5 – Tiedemann-Sawitzky.pdf(1.6 MB)
Preparation and management of Phase I studies with stem cell therapy
Wang, D.
Session1 Fixed dosing Diane Wang.pdf(1.1 MB)
Fixed dosing versus weight-based dosing in clinical development of biotherapeutic proteins
Yanaz, R.
Yanez Rafael Gene Therapy Studies.pdf(2.5 MB)
Gene Therapy Studies