As part of efforts to “renovate” its good clinical practice (GCP) framework, the International Council for Harmonisation has framed new overarching GCP principles that can be applied to diverse trial types and data sources.
The International Council for Harmonisation has published a document offering a sneak preview of the new overarching principles that are to form the basis of its revised guideline on good clinical practice requirements (ICH E6 (R2)).
The ICH E6(R2) serves as an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that...
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
To help sponsors developing candidate mpox vaccines, the World Health Organization will soon be finalizing guidance on the preferred and minimum characteristics these products must satisfy regarding efficacy, dose regimen and other aspects to secure regulatory approval.
The WHO’s emergency committee has warned of a lack of understanding of the epidemiology of mpox, the limited availability of vaccines, and the complexities of donations and procurement.
An ongoing collaborative initiative involving global regulators assessing post-approval manufacturing changes has highlighted the need to establish a standardized platform that can facilitate the submission and regulatory evaluation of such changes.
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.
