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)

Therapeutic equivalence of nasal products – comparison of quality attributes

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)

From practice to evidence: Leveraging unique Czech RWD to support regulatory documentation

Patrik Cachnín (TME solutions)

ICH M13B

Jiří Hofmann (Zentiva)

PBPK analysis for pediatric extrapolation

Anuradha Kulasekaran (Reckitt Health)

OIP development in practice: Overcoming barriers to bioequivalence

Zuzanna Miś, Przemysław Reszka (Polpharma)

ICH M15, and the implications for model based IVIVC (PBPK, popPK) 

Paula Muñiz (CTI)

Generic oligonucleotides

Liselijn Wisman (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)