Nieuws

Yahoo Finance

FDA eCTD (Electronic Common Technical Document) Fundamentals and Process Submissions Course (ON-DEMAND)

Dublin, June 27, 2024 (GLOBE NEWSWIRE) -- The "eCTD Submissions - Fundamentals and Process" training has been added to ResearchAndMarkets.com's offering. eCTD Submissions, or electronic Common ...
Yahoo Finance

Filing eCTD (electronic Common Technical Document) Submissions Training Course: Now Mandatory for Submissions in the EU and Global regulatory Agencies

Dublin, Aug. 01, 2023 (GLOBE NEWSWIRE) -- The "Filing eCTD Submissions Training Course" conference has been added to ResearchAndMarkets.com's offering. This intensive one-day course will provide an ...
Medindia

Intrasphere Technologies Releases PharmaCM Submissions Management and Authoring Module Powered by Microsoft Office SharePoint Server 2007

NEW YORK, Feb. 5 Intrasphere Technologies, a leadingconsulting firm that provides business-focused services and solutions to lifesciences organizations, announced today that the company's ...
Yahoo Finance

Common Technical Document (CTD) and Clinical Overview Guideline Course: Creating Effective Marketing Authorisation Applications (ONLINE EVENT: June 18-19, 2025)

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

eCTD now mandatory for the Centralized Procedure

In 2005, the heads of the European medicines agencies agreed that all EU member states must have the infrastructure and processes in place to handle only electronic Common Technical Document (eCTD) ...
PharmTech

Drug Master Files: Requirements and Challenges

The author describes several issues in creating drug master files and active substance files for active pharmaceutical ingredients and intermediates. This article covers the submission requirements ...