“Good Lay Summary Practice” Recommendations
The new tool you should use to comply with the European Clinical Trial Regulation (EU No. 536/2014)
DescriptionA multistakeholder group consisting of 60+ academic, industry, not-for-profit and patient organisations, jointly led by EFGCP and EFPIA, (“Roadmap Initiative for Good Lay Summary Practice”), compiled needs for transparency improvement on clinical study results, available guidance and experience when preparing and disseminating Lay Summaries (LS) in Europe and the US. Based on existing recommendations for Lay Summary structure and content, recommendations for the planning, development, translation, and dissemination of LS with systematic patient involvement were developed in collaboration with the Commission’s Expert Group on Clinical Trials (CTEG) and published by the EU Commission in EudraLex Volume 10 (link).
This free webinar will give you an opportunity to learn about these new European recommendations and provide you with ideas on how and when to be ready to fulfil this new regulatory requirement.