Symposium D3
Benefit-risk planning through the product life cycle

Tuesday 23 May 2017
Stockholmsmässan : A2


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.

Rogerio Gaspar, University of Lisbon, Portugal

Pieter Stolk, Utrecht University, The Netherlands


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