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EMA's consultation on ICH-E8(R1) Guideline on Clinical Studies

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EMA has published a revision of the ICH-E8 Guideline for consensus building: GENERAL CONSIDERATIONS FOR CLINICAL STUDIES.

This version is a revision of the original E8 guideline from 1998. It covers topics like

- General principles (protection of subjects, scientific approach and patient input)
- Designing quality into clinical studies
- Drug development planning
- Design elements for clinical studies
- Conduct and reporting
- Considerations in identifying critical to quality factors

Please find here the link to the EMA webpage:

EFGCP would like to submit comments - critique and constructive suggestions – on topics of relevance to our vision and mission. All members are free to send their own comments to EMA but it is believed that the comments will have a higher weight if presented under the EFGCP banner.

Dr Klingmann is looking for volunteers who either send comments to her directly or would be willing to form an EFGCP response team. Deadline for comment submission is 30 September 2019.

Ingrid Klingmann, MD, PhD
EFGCP Chairman

Who should register?

Healthcare professionals who wish to be part of a unique network, providing access to up-to-date, accurate and validated information about clinical research.

Investigators and study staff who wish to be part of a unique network, in order to stay abreast of clinical trials taking place in Luxembourg and who are willing to further develop their competencies.