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Thursday, September 21
9:10–10:20 Morning session 1
M13 guideline series: status update
Susana Almeida (Medicines for Europe)
Volodymyr Stus (Polpharma)
10:40–12:10 Morning session 2
Jiří Hofmann (Zentiva)
Paolo Biffignandi (VI.REL Pharma)
pAUCs and clinical relevance for LALA
Vit Perlik (Faculty of Medicine, Charles University, Consultant)
13:40–15:10 Afternoon session 1
Paulo Paixão (Universidade de Lisboa)
Current thinking of a tailored clinical approach in biosimilars
René Anour (AGES)
Equivalence for lozenges: in vitro in vivo and link between both
Jean-Michel Cardot (Consultant)
15:30–17:00 Afternoon session 2
Detection of data manipulation in bioequivalence trials
Anders Fuglsang (Fuglsang Pharma)
Sex– and group-related problems in BE – a delusion
Helmut Schütz (BEBAC)
Comparison and interpretation of dissolution time profiles of oral tablets using
Stefan Horkovics-Kovats (Consultant)
Friday, September 22
9:00–10:10 Morning session 1
RWE – real world evidence/RWD real world data
Steffen Thirstrup (CMO EMA)
RWE – real world evidence/RWD real world data – case study
Mariusz Mogielnicki (Polfarma)
11:00–12:30 Morning session 2
BCS-based biowaivers and waivers for additional strength, M 13 comments
Mary Malamatari (MHRA)
Well-established use – case studies
Jana Klimasová (SUKL)
Hybrid as registration route for alternative formulations and posologies to increase
Paula Muñiz (CTI)