
Preliminary program
Start of the meeting: Thursday, September 25, 9:00
End of the meeting: Friday, September 26, 14:00 (after lunch)
Product specific guidance EMA vs FDA, need for an additional study with a proton pump inhibitor for generics
Carolien Versantvoort (MEB)
OIP/nasal: Dissolution, MDRS, quality
Peter Caspers (MEB)
Biosimilars – update
René Anour (AGES)
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)
RWE data from “public” sources, supporting FDC, hypothesis testing (UZIS database)
Petr Břicháček (TME Solutions)
ICH M13B
Jiří Hofmann (Zentiva)
PBPK analysis for pediatric extrapolation
Anuradha Kulasekaran (RB)
OIP reflections – in vitro and pAUCs
Zuzanna Miś (Polpharma)
ICH M15, and the implications for model based IVIVC (PBPK, popPK)
Paula Muñiz (CTI)
Generic oligonucleotides (tentative)
Sandra van Os (Synthon)
pAUCs case study and more beyond…
Vit Perlik (BioBridges)
Inflation of guidelines – EMA guideline („old BE gdl“), ICH M13A and PSBGs
Kumar Ramu (QPS)
Bridging clinical practice and regulation: Bioavailability of LAI and MR antipsychotics in light of EMA guidelines
Simona Savu (3S)
Semaglutide with salcaprozate sodium (SNAC) – ICH M13A food effect
Nuno Silva (Universidade de Lisboa)