Interactions with Health Authorities and the ICH E9(R1) working group

Published

November 25, 2022

We are grateful for ongoing collaboration and regular dialogue to statisticians from European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA, UK), U.S. Food and Drug Administration (FDA), Pharmaceuticals and Medical Devices Agency (PMDA, Japan), Health Canada, Swissmedic, National Medical Products Administration (NMPA, China) and Center for Drug Evaluation (CDE, Taiwan).

Below you find the summaries of material presented at regular meetings with these stakeholders.

Date Audience Material
2020/09 Full group + regulators Slidedecks and/or written updates
2022/06 Full group + regulators Slidedecks and/or written updates

We also thank Keaven Anderson (Merck) and Frank Bretz (Novartis) for their support.