Expert meeting on clinical investigation of new drugs for the treatment of chronic hepatitis C in the paediatric population

• Date:
  Monday, 4 April 2011, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

The objective of the meeting is to discuss the clinical development of new drugs for the treatment of chronic hepatitis C in the paediatric population, taking into consideration possible differences between the adult and paediatric population in particular in terms of safety and possibility to extrapolate efficacy from the adult data.

Documents

Agenda - Expert meeting on clinical investigation of new drugs for the treatment of chronic hepatitis C in the paediatric population

Adopted Reference Number: EMA/97974/2011

Minutes of expert meeting on clinical investigation of new drugs for the treatment of chronic hepatitis C in the paediatric population: Monday 4 April 2011

Adopted Reference Number: EMA/251093/2011

Presentation - European Medicines Agency/Committee for Medicinal Products for Human Use draft guidance on paediatric hepatitis C virus drug development; what, when, who, how?

Presentation - Treatment of chronic hepatitis C virus infection in children and adolescents: Guidance for clinical trials

Presentation - Paediatric-investigation-plan applications assessed by the Paediatric Commitee for the treatment of chronic hepatitis C in children

Presentation - Objectives expert meeting: List of questions: Preliminary answers