European Medicines Agency-EuropaBio information day

• Date:
  Tuesday, 22 November 2016, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

The fourth EMA-EuropaBio information day participants discuss three main topics: innovation and development support, international cooperation with Medicines Agencies, and evidence generation during medicinal life-cycle.

Documents

Summary report of the European Medicines Agency-EuropaBio information day - 22 November 2016

Agenda - European Medicines Agency-EuropaBio information day

Reference Number: EMA/723535/2016

Presentation - Adaptive Pathways: Can we build better links between decision makers? (Francesca Cerreta)

Presentation - EMA-HMA Network international initiatives on innovation (Martin Harvey Allchurch)

Presentation - Early dialogue: Focus on PRIME (Rob Hemmings)

Presentation - FDA International, Europe (Colin McKiff)

Presentation - International regulatory activities based on PMDA International Strategic Plan 2015 (Hideyuki Kondo)

Presentation - PNH indication update based on data from Global Registry(Martine Zimmermann)

Presentation - PRIME first experiences (James Kennard)

Presentation - Role of real world evidence to foster access to innovative diabetes medicine (Agathe Le Lay)

Presentation - Scientific advice delivers planning throughout development (Thorsten Vetter)

Presentation - The use of historical control data to assess the benefits of new therapies: A case study of blinatumomab versus standard therapy of adults relapsed/refractory acute lymphoblastic leukaemia (Maurille Feudjo...

Presentation - What are the real-world evidence tools and how can they support decision making? (Dr Alison Cave)