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45 - PHR - Pharmaceutical Sciences

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

Code	Start Date	Duration	Venue
PHR 115	07 October 2024	5 Days	Istanbul	Registration Form Link
PHR 115	11 November 2024	5 Days	Istanbul	Registration Form Link
PHR 115	16 December 2024	5 Days	Istanbul	Registration Form Link

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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

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SAHARA Group Training and Consultancy INC (in Turkish: SAHARA Group Eğitim ve Danışmanlık AŞ)

Tax Office: Beyoğlu (Istanbul/Turkiye,Tax No: 7390525151 (Vergi Dairesi: Beyoğlu (İstanbul), Vergi No: 7390525151)

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(Click Category to List Courses)

45 - PHR - Pharmaceutical Sciences

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

Course Description

Course Objectives

Who Should Attend?

Course Details/Schedule

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