AGENDA

This two-day series of events consists of a COURSE DAY (October 5th) and a professional SYMPOSIUM DAY (invited presentations and round table session, scheduled for October 6th) regarding hot topics related to the development of biosimilars with strong FOCUS ON Statistical and Regulatory Perspectives.

11:00 – 12:00 

1st Day Registration

12:00 – 13:00

Scientific factors in biosimilar product development
László ENDRÉNYI,
Professor Emeritus of Pharmacology and Biostatistics, University of Toronto;
Former President of Canadian Society for Pharmaceutical Scientists

13:00 – 14:00 

Lunch break

14:00 – 17:40

Open issues in the assessment of bioequivalence and biosimilarity
The course is lectured by:
Helmut Schütz,
Owner at BEBAC – Consultancy Services for Bioequivalence and Bioavailability Studies
Main topics of the course:
  • Unequal carry-over – “solved” in BE but still an Issue in Assessing Biosimilarity?
  • Multi-Group and Multi-Site Studies. To pool or not to pool?
  • Group-Sequential and Two-Stage Designs.
  • Reference-scaling and Control of the Type I Error.
Schedule of the course:
14:00 – 15:00   |   1st part of COURSE
15:00 – 15:20   |   Coffee break: refreshments & networking
15:20 – 16:20   |   2nd part of COURSE
16:20 – 16:40   |   Coffee break: refreshments & networking
16:40 – 17:40   |   3rd part of COURSE

17:40 – 18:00

Discussion