Workshop on endpoints for cystic fibrosis clinical trials

• Date:
  Thursday, 27 September 2012, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

The Agency is holding a two-day workshop on 27-28 September 2012 focusing on outcome measures for cystic fibrosis (CF) lung disease and exocrine pancreatic insufficiency, gathering experts in the field of CF together with regulators, pharmaceutical industry, and patient representatives. Registration by invitation only. Registration open until 31/07/2012. Places limited.

Documents

Agenda - Workshop on endpoints for cystic fibrosis

Reference Number: EMA/895687/2011

Report of the workshop on endpoints for cystic fibrosis clinical trials

Reference Number: EMA/769571/2012

Presentation - Workshop on endpoints: cystic fibrosis clinical trials

Presentation - Cystic fibrosis demographic challenges for Europe (J Stuart Elborn)

Presentation - Difficulties and challenges encountered - look into the future: academia perspective (Kris De Boeck)

Presentation - Challenges encountered in clinical trials in CF: patient perspective (Emma Lake)

Presentation - Cystic fibrosis endpoints: difficulties encountered in the orphan procedures (Laura Fregonese)

Presentation - Experience with CF in scientific advice (Efthymios Manolis)

Presentation - Difficulties encountered – regulatory perspective: Paediatric Investigation Plans (Irmgard Eichler)

Presentation - Difficulties encountered - regulatory perspective: focus on endpoints used in clinical trials (Concha Prieto)

Presentation - Clinical trials in CF - regulatory perspective: endpoints for added clinical benefit in view of HTA (Paolo D. Siviero)

Workshop on endpoints for cystic fibrosis clinical trials - Call for expression of interest

Reference Number: EMA/385817/2012