Programme
Symposium D3
Benefit-risk planning through the product life cycle
Tuesday 23 May 2017
15:00-18:00
Stockholmsmässan : A2
Introduction
A benefit risk-assessment of a medicine is not a single assessment that takes place during one moment in time.
Rather, benefit-risk assessments take place throughout the product life cycle and can be update regularly. Also,
the nature of the tools and methods available is dynamic: from early stage drug development until the late
post-marketing phase. This session will be exploring cutting-edge approaches in this area.
Co-chairs
Rogerio Gaspar, University of Lisbon, Portugal
Pieter Stolk, Utrecht University, The Netherlands
Programme
15:00 – 15:10 Opening Remarks
15:10 – 15:45 Standards of evidence for regulatory decision making
Rob Hemmings, EMA/MHRA, USA
15:45 – 16:20 Building substantial evidence never ends
Carl Peck, UCSF, USA
16:20 – 16:40 BREAK
16:40 – 17:15 Industry perspective on life-cycle management
Jens Heisterberg, Novo Nordisk, Denmark
17:15 – 17:50 Value for money through the product life cycle
Lloyd Sansom, University of South Australia, Australia
17:50 – 18:00 Concluding remarks
Rogerio Gaspar, University of Lisbon, Portugal
