Session 7 Topic of Special Interest I: Orphan Drug Regulations

Session 7-1 Teaching Materials

Session 7-2 Teaching Materials

Lecture 1:

Regulatory Perspective of Orphan Drug Development for Rare Diseases -Yen-Hui Wu 

Lecture 2:

An Overview of the European Orphan Regulation - Kristina Larsson 

  ◆  Procedure for orphan designation 

  ◆  Marketing authorisations of orphan drugs 

  ◆  International Collaboration 

  ◆ Tips and tricks (i.e., lessons learned over the years)