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Thursday, September 24
9:00–10:30 Morning session 1
Update on regulatory landscape – use of in vitro similarity comparison
René Anour (AGES)
Industry perspective and scientific background for current in vitro similarity comparison
Martin Schiestl (Sandoz)
10:50–12:20 Morning session 2
PBPK biologics rituximab and small molecules
Ondřej Slanař (Institute of Pharmacology, 1st Faculty of Medicine, Charles University)
The use of PBBM for biopharmaceutics risk assessment, with apixaban as a model drug
Paulo Paixão (Pharmacy Faculty of Lisbon University)
13:40–15:10 Afternoon session 1
ICH M12 drug interactions – emerging areas on drug interaction guidance
Carolien Versantvoort (MEB)
Esther Lubberts (MEB)
15:30–17:30 Afternoon session 2
To pool, or not to pool, that is the question…
Helmut Schütz (BEBAC)
Complex developments – LAI, the role of partial AUCs
Lida Kalantzi (Pharmathen)
ICH M13B final and associated Q&A, comments
Susana Almeida (Viatris)
Friday, September 25
9:00–10:20 Morning session 1
Peter Caspers (MEB)
Application of regulatory landscape for LALA – ophthalmics (cry or not to cry…:-)
Marina Feřtek, Nora Šotolová (Synavia)
10:40–12:40 Morning session 2
Jean Michel Cardot (SAS Borvo)
Mastering IVRT and IVPT: From technical complexity to scientific confidence
Magali Breisse (Eurofins)
In-vivo armamentarium & integrated assessment for locally applied products
Kumar Ramu (QPS)