Video
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.
Featuring:
- Julie Farides-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
