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44 - PHR - Pharmaceutical Sciences

PHR 115 - Preparing the Pharmaceutical Module of the Global CTD Dossier

Code Start Date Duration Venue
PHR 115 27 March 2023 5 Days Istanbul Registration Form Link
PHR 115 22 May 2023 5 Days Istanbul Registration Form Link
PHR 115 17 July 2023 5 Days Istanbul Registration Form Link
PHR 115 11 September 2023 5 Days Istanbul Registration Form Link
PHR 115 06 November 2023 5 Days Istanbul Registration Form Link
PHR 115 11 December 2023 5 Days Istanbul Registration Form Link
Please contact us for fees


Course Description

The guidance on marketing applications for drugs and biologics known as the Common Technical Document (CTD) was finalized by the International Conference on Harmonization (ICH) in 2003. Today the CTD format is highly recommended for marketing applications in the United States and is mandatory in other regions including Canada, Japan, and Europe. This course is designed as a review of current regulatory guidelines and how they affect strategies in the development, preparation, and successful submission of eCTDs. The foundation of the CTD’s organization, structure, and granularity are explained along with their applicability on templates and submission-ready sections and reports.

Course Objectives

  • Developing project plans for the compilation of compliant eCTD submissions
  • Identifying processes employed in preparing CTD/eCTD submissions
  • Understanding how to prepare CTD content templates and requirements
  • Recognizing requirements specific to electronic submissions, implications on predicate rules
  • Identifying tools and technology used in preparation and review of eCTDs
  • Learning about global CTD dossiers assembling, working on classic and virtual submission teams

Who Should Attend?

  • Professionals of the biotechnology and pharmaceutical industries
  • Regulatory Affairs / Regulatory Operations
  • Submissions Management
  • Authors of CTD Sections
  • Technical and Clinical Writers
  • Documentation Teams
  • Project Management
  • Information Technology and Information Systems Teams

Course Details/Schedule

Day 1

  • Introduction and Overview of The (CTD) eCTD basics and terminology
  • eCTD specifications
  • Submission structure and organization
  • Technical elements of the eCTD, including file formats

Day 2

  • Nonclinical Study Reports
  • Clinical Study Reports
  • General and regional requirements
  • Metadata, folder structure, and lifecycle

Day 3

  • Study tagging files
  • Node extensions
  • Organization of clinical study reports following eCTD specifications
  • Case Report Forms (CRFs)

Day 4

  • Study data specification
  • eCTD Navigation and Cross-Referencing
  • Strategies for setting up document navigation

Day 5

  • Supportive documentation and literature references
  • Multi-Region Submissions
  • Regional Requirements