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Thursday, September 21

9:10–10:20 Morning session 1

M13 guideline series: status update

Susana Almeida (Medicines for Europe) 

M13 and QndA DPIs

Volodymyr Stus (Polpharma) 


10:40–12:10 Morning session 2


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) 

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

a first-principles-based disintegration-dissolution model: a contribution to modelinformed drug development

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

patient comfort/adherence

Paula Muñiz (CTI)