PDF files containing presentations will be displayed and can be downloaded after clicking on a presentation itself.
Thursday, September 25
9:10–10:30 Morning session 1
René Anour (AGES)
Liselijn Wisman (Synthon)
11:00–12:30 Morning session 2
Inflation of guidelines – EMA guideline (“old BE gdl”), ICH M13A and PSBGs
Kumar Ramu (QPS)
Semaglutide with salcaprozate sodium (SNAC) – ICH M13A food effect
Nuno Silva (Universidade de Lisboa)
13:45–15:30 Afternoon session 1
Product specific guidance EMA vs FDA, need for an additional study with a proton pump inhibitor for
generics
Carolien Versantvoort (MEB)
pAUCs case study and more beyond …
Vit Perlik (BioBridges)
Bridging clinical practice and regulation: bioavailability of LAI and MR antipsychotics in light of EMA
guidelines
Simona Savu (3S)
16:00–17:30 Afternoon session 1
Jiří Hofmann (Zentiva)
Evaluation of Incurred Subject Period Re-analysis (ISPR) as a tool to distinguish fraudulent
pharmacokinetic profile pairs from non-fraudulent pairs
Anders Fuglsang (Fuglsang Pharma)
Friday, September 26
9:00–10:30 Morning session 1
Therapeutic equivalence of nasal products – comparison of quality attributes
Peter Caspers (MEB)
OIP development in practice: Overcoming barriers to bioequivalence
Zuzanna Miś, Przemysław Reszka (Polpharma)
11:00–12:30 Morning session 2
ICH M15, and the implications for model based IVIVC (PBPK, popPK)
Paula Muñiz (CTI)
PBPK analysis for pediatric extrapolation
Anuradha Kulasekaran (Reckitt Health)
From practice to evidence: Leveraging unique Czech RWD to support regulatory documentation
Patrik Cachnín (TME solutions)