
Preliminary program
Thursday, September 21
M 13 comments
Susane Cole (MHRA)
M 13 comments
Susana Almeida (Medicines for Europe)
NTIs
Paulo Paixão (Universidade de Lisboa)
Sex- and group-related problems in BE – a delusion
Helmut Schütz (BEBAC)
M13 and QndA DPIs
Volodymyr Stus (Polpharma)
Tmax/pAUCs
Jiří Hofmann (Zentiva)
Tadalafil Tmax – case study
Paolo Biffignandi (VI.REL Pharma)
pAUCs and clinical relevance for LALA
Vit Perlik (Faculty of Medicine, Charles University, Consultant)
Equivalence for lozenges: in vitro in vivo and link between both
Jean-Michel Cardot (Consultant)
Friday, September 22
RWE – real world evidence / RWD – real world data
Steffen Thirstrup (CMO EMA)
RWE – real world evidence / RWD real world data – case study
Mariusz Mogielnicki (Polpharma)
Detection of data manipulation in bioequivalence trials
Anders Fuglsang (Fuglsang Pharma)
Comparison and interpretation of dissolution time profiles of oral tablets using a first-principles-based disintegration-dissolution model: A contribution to model-informed drug development
Stefan Horkovics-Kovats (Consultant)