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)