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)