Location: FAMHP

Programme

09.00 Welcome & Opening remarks
Marc Benijts

09.15 Overview CTD - Non clinical related issues
Sonja Beken

09.45 Non clinical pharmacological studies
Jean-Michel Dogné

10.30 Coffee break

10.45 Pharmacokinetic concepts
Roger Verbeeck

11.45 Non clinical safety testing
Sonja Beken

12.30 Lunch

13.30 Environmental Risk Assessment
Claire Beuneu

14.00 Non clinical requirements for clinical trials
Walter Janssens

14.45 Coffee break

15.00 Alternatives for animal testing (3R)
Vera Rogiers

15.45 Non clinical requirements for biologicals
Jan-Willem Van der Laan

16.30 Coffee break

16.45 Non clinical requirements for vaccines
Ozzie Berger

17.30 Non clinical requirements for Biosimilars
Karen De Smet

18.00 Closing remarks
Marc Benijts

18.15 End of the Advanced Course: CTD Module 4

This one day session is accessible to BRAS members and non members.