European Equivalence Consideration for Orally Inhaled Products for Local Action

12 - 13 October 2010, Frankfurt, Germany

Introduction

European experiences with equivalence determinations for inhaled products will be the main focus of the workshop co-organized by ISAM and IPAC-RS. Canadian and US perspectives will also be represented. The program includes presentations from several regulatory agencies, academia and industry, as well as interactive breakout sessions on such topics as
• Design of Equivalence Studies.
• In Vivo Tests (PK, PD, Biomarkers).
• "In Vitro Only" Equivalence.
• Device Design Similarity and Testing Needed to Support Device Changes.