On January 21, 2022, the European Medicines Agency (EMA) launched a new clinical trials website, Clinical Trials Information System (CTIS). The new website was launched with the application of the new clinical trials regulation, Regulation (EU) No 536/2014.
The regulation requests a plain language version of the protocol synopsis to be submitted as part of the initial application for a clinical trial.
Hear from CISCRP colleagues and industry experts who discuss creating a plain language protocol synopsis that can be used for non-expert audiences, preparing plain language summaries of trial results to meet the new regulation, and best practices for developing and implementing a plain language summary program.
Panelists:
Julie Faries-Mitchell, MS
Associate Director
Health Communication Services
CISCRP
Christopher Pfitzer
Associate Director
Transparency Operations Lead
UCB Biosciences, Inc.
Kim Edwards, PhD
Associate Director
Medical Writing
CISCRP
To access more educational content about clinical trials and clinical research participation click here.
