Dublin, May 19, 2025 (GLOBE NEWSWIRE) -- The "Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application Training Course" training has been added to ...

Dublin, Nov. 14, 2025 (GLOBE NEWSWIRE) -- The "The Common Technical Document (CTD) Submission in the MENA Region Training Course (Nov 28, 2025)" training has been added to ResearchAndMarkets.com's ...

FDA Offers New ICH Guidance on Organizing a CTD The US Food and Drug Administration (FDA) this week released a guidance that is part of a series from the International Council of Harmonisation (ICH) ...

For ten years the International Conference on Harmonisation (ICH) has set about achieving a common format for the dossier that must be submitted to gain approval for medicinal products in all three ...

The pharmaceutical industry has expressed a need for greater clarity regarding the timeline for converting quality information for new and existing drug and biologics dossiers to the common technical ...