戻る Agenda
“ICH clinical trials and pharmacovigilance - preparing for the future”
Session Chair(s)
Sabine Brosch, PHARMD, PHD, MPHARM
Data Protection Officer
European Medicines Agency, Netherlands
Fergus Sweeney, PHD
Head of Clinical Studies and Manufacturing Task Force
European Medicines Agency, Netherlands
This session will focus on an update of the Good Clinical Practice (GCP) "Renovation" including the revision of the current general considerations for clinical trials [E8] and the further review of the GCP guideline [E6]. Highlights on the methodological approaches in clinical trials based on statistical principles [E9(R1)] and paediatric extrapolation [E11A] as well as the design, conduct, analysis and interpretation of adaptive clinical trials [E20] will be also presented. Latest developments in the area of the pharmacovigilance guidelines [E2] will conclude the session followed by questions to be addressed by the audience.
Speaker(s)
The Good Clinical Practice (GCP) Renovation
Lisbeth Bregnhøj, PHD, MPHARM
The Danish Medicines Agency, Denmark
EC ICH E6(R3) Expert Working Group Member
Methodological Approaches in Clinical Trials
Frank Bretz, PHD
Novartis , Switzerland
Distinguished Quantitative Research Scientist
Latest developments in the E2 pharmacovigilance guidelines
Sabine Brosch, PHARMD, PHD, MPHARM
European Medicines Agency, Netherlands
Data Protection Officer