戻る Agenda
ICH Info Day – Part 2
Session Chair(s)
Pär Tellner, MPHARM, MSC, RPH
Director, Regulatory Affairs
EFPIA, Belgium
Part 2 of the ICH Info Day focuses on the Safety guideline S1 on criteria for when to conduct rodent carcinogenicity studies and on the Efficacy guideline E8 as the first step towards the GCP renovation initiated in 2017.
Speaker(s)
Introduction
Pär Tellner, MPHARM, MSC, RPH
EFPIA, Belgium
Director, Regulatory Affairs
Carcinogenicity Studies S1
Tania Cecilia Cavaliero, DVM
Swissmedic, Switzerland
Preclinical Assessor
General Considerations for Clinical Trials E8 (GCP Renovation)
Fergus Sweeney, PHD
European Medicines Agency, Netherlands
Head of Clinical Studies and Manufacturing Task Force