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 ...

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

(MENAFN- GlobeNewsWire - Nasdaq) Join this comprehensive two-day course to master CMC management for full and generic applications. Enhance your skills in CTD compilation, Module 3 submission, and ...

The US Food and Drug Administration finalized a Guidance for Industry this week that aims to clarify the submission of new drug applications (NDAs) and biologics license applicants (BLAs) using the ...

Drug approval is the goal of the long process of drug development. Once preclinical and clinical trial data have been collected, a New Drug Application must be submitted to the regulatory authority ...

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) ...

Regulators at Health Canada have announced the finalization of guidance intended to assist sponsors in preparing electronic common technical documents (eCTDs) to submit their pharmaceutical dossiers ...

Small and Medium Pharmaceutical Industry Centre (SMPIC) NIPER-SAS Nagar is organising a one-day interactive session for all manufacturers, regulators and suppliers of pharma industry on ‘Common ...

(MENAFN- GlobeNewsWire - Nasdaq) Dublin, May 19, 2025 (GLOBE NEWSWIRE) -- The "Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application Training Course" training ...