Scientific Advice Session at the 7th TOPRA Symposium London
Price: £50.00
This session will cover Scientific Advice at European level at the EMA but
also from a National Agency and Industry perspective. It will discuss recent
experiences of pilot Joint Scientific Advice including Health Technology
Assessment (HTA) and how this might develop in the future. Is Parallel
Scientific Advice between US and EU still alive?
- Introduction - Margareth Jorvid – Senior Partner, LSM Group and TOPRA
Board Director, Sweden - Does Scientific Advice in Europe make a difference? - Bruno Flamion – Chair, Scientific Advice Working Party, EMA and University of Namur, Belgium
- Scientific Advice in Europe
- Recent developments
- Future changes
- Scientific Advice from a National Agency perspective - Bengt Ljungberg – Head of Section Pharmacotherapy, MPA, Sweden
- National Scientific Advice – how does it work?
- A report on a pilot of joint scientific advice including HTA
- Is HTA there to stay?
- Industry Experience of joint HTA and Regulatory Authority Scientific Advice - Isabella Sanderfelt – Head of Regulatory Affairs, Pfizer, Sweden
- Differences in preparation
- How did it work?
- Future development – good or bad?
- Panel discussion with this session’s speakers and invited panellist: Janice Soreth – US FDA Liaison at EMA
- Update on Parallel Scientific Advice (US/EU).
- Is the EU approaching the US way of regular scientigic advice during
development? - Is HTA here to stay?
