PDF files containing presentations will be displayed and can be downloaded after clicking on a presentation itself.

DAY 1 (September 22, 2022)

9:00–10:30  Morning session 1


Biosimilars and orphan medicinal product development

Rene Anour (AGES)


Improvement of PK drug properties – development and regulatory perspective 

Tomáš Hauser (Zentiva)


11:00–12:30  Morning session 2


ICH M13 BES harmonization – basic prerequisites 

Susana Almeida (Medicines for Europe)


EMA News in dissolution 2020–2022 

Jean-Michel Cardot (Consultant)

14:00–15:30  Afternoon session 1


Untangling absorption mechanisms and variability in bioequivalence studies using population analysis 

Nuno Silva (Universidade de Lisboa)


Locally applied Locally acting in GIT – biowaivers

Jean-Michel Cardot (Consultant)


16:00–17:00  Afternoon session 2

Locally applied, locally acting products 

Flavian Radulescu (University of Medicine and Pharmacy)

DAY 2 (September 23, 2022)

9:00–10:30  Morning session 1


Product specific guidelines – Tmax criteria 

Graham Pennick (Reckitt Benckiser)


Tmax evaluation – where do we go… 

Helmut Schütz (BEBAC)

11:00–12:30  Morning session 2


Partial AUCs – tool for development vs regulation 

Vít Perlík (BioBridges, Consultant)


Product specific guidelines 

Loice Kikwai (Consultant)