Symposium D1
New approaches of regulating innovative medicines

Monday 22 May 2017
15:00-18:00
Stockholmsmässan : A2

Introduction

Throughout the world, regulators are exploring new ways to provide access to patients for innovative
medicines that address urgent medical needs at the earliest moment, while assuring appropriate controls for
quality, safety and efficacy. In this session we will assess current approaches in different regulatory systems,
explore commonalities and identifies lessons for the future.

Co-Chair(s): Alasdair Breckenridge, UK

Programme

15:00 – 15:10 Opening remarks
Alasdair Breckenridge, University of Liverpool, UK 

15:10 – 15:45 To Adapt or not to Adapt
Hans-Georg Eichler, European Medicines. Agency, UK 

15:45 – 16:20 Exploring innovative regulatory pathways: A US perspective

Larry Liberti, Centre for Innovation in Regulatory Science (CIRS), USA

16:20 – 16:40 BREAK

16:40 – 17:15 Industry perspectives on regulating innovative medicines
Joseph Scheeren, Bayer, Switzerland  

17:15 – 17:50 PMDA's contribution to innovative medicines
Toshiyoshi Tominaga, PMDA, Japan,  

17:50 – 18:00 Concluding remarks
Alasdair Breckenridge, University of Liverpool, UK