Advanced Level Training Courses

EXTEDO offers Advanced Level training courses for customers who want to enhance their knowledge of the respective product and have already successfully accomplished a basic level training course. Some training courses are technically oriented; others are focussing on regulatory questions.

These training courses can be offered separately and performed via a web conferencing tool.

For reasons of higher effectiveness EXTEDO recommends that the customer selects a set of modules to a full day, according to his needs.

eCTD Specification

ICH eCTD Specification V 3.2.2 (Duration: 2 hrs, Code: S_ICH_01)

• Implementation of ICH eCTD Specification V 3.2.2 requirements in eCTDmanager
• Implementation of selected requirements of ICH Annex 1-4 and 7 

____________________________________________________________

Dossier & Submission Types

Dossier Types (Duration: 1hr, Code: S_DOS_01)

• Learn about different dossier types in eCTDmanager
• eCTD (Regions: EU; US-FDA)
• NeeS
• IMPD / CTA  / generic dossiers
• Re-use of manually created structures

____________________________________________________________

Marketing Authorization Procedures & eCTD Submission types in eCTDmanager (Duration: 2hrs, Code: S_SBMT_01)

• Centralized Procedure
• National Procedure
• MRP/DCP

____________________________________________________________

eCTD Modules (Duration: 2hrs, Code: S_MOD_01)

• Specifics in eCTD Modules 1-5
• Reference to EU-CTD (NTA, Vol. 2B)

____________________________________________________________

Regional-specific eCTDs

CH module 1 vs EU M1, Variations in EU & CH (Duration: 2 hrs, Code: S_CHVAR_01)

• Specifics of Swiss M1 vs. EU M1:
  • Galenic Form
  • Swiss Procedure Types
  • EU/CH Variations

____________________________________________________________

US (FDA) Submission (Duration: 2 hrs, Code: S_USCA_01)

• Module 1 structure & specifics
• Module 4 and Module 5: STF, SAS

____________________________________________________________

GCC Module 1 (Duration: 1 hr, Code: S_GCC_01)

• GCC submission specifics
• Module 1: special requirements of GCC / GCC-specific documents

____________________________________________________________

South Africa Modules 1, 3.2.R (Duration: 1 hr, Code: S_ZA_01)

• Specifics of ZA M1 vs EU M1
• Specific ZA documents

____________________________________________________________

Application-specific eCTDs

Homeopathic/Anthroposophic Submissions (Duration: 1 hr, Code: S_HoA_01)

• Requirements from 2001/83/EG and German AMG
• “Application” vs. “Registration”
• Structure and specific requirements of homeopathic/anthroposophic submissions

____________________________________________________________

Veterinary NeeS (Duration: 1 hr, Code: S_VN_01)

• Regulations & guidelines
• Different VNees structures (immunological, pharmaceutical, MRL)
• Required TOCs
• Export settings

The comprehensive MRP Model in eCTDmanager 3.0  (Duration: 2 hrs, Code: S_MRP3_01)

• The MRP Goal
• Business Case
• Software Solution

____________________________________________________________

Active Substance Master File/Drug Master File in eCTDmanager (Duration: 2 hrs, Code: S_ASMF_01)

• Different ways of creating ASMF/DMF:
  • section level (S-Part)
  • document level (document attributes)
• DMS and document lifecycle support
• Preparation of Customer Specific Type Descriptor
• Set Section Attributes
• Publishing Parameters

____________________________________________________________

Submission Staging and Regulatory Activities (Duration: 2 hrs, Code: S_PARS_02)

• Parallel Sequences are “out-of-sequence submissions”
• Regulatory Activities help structuring submissions
• Parallel submissions handling
• Creation and merging of parallel submissions
• Submission Staging and Incremental Export
• Lifecycle and Regulatory Activity view

____________________________________________________________

Incremental Export (Duration: 2 hrs, Code: S_INCR_01)

Incremental Export of a submission:

• Handle time-critical last minute changes in a fast and efficient way
• Only those parts and documents of a submission are exported that have been added or modified since the last export
• Incremental export can also be used in a submission staging context

____________________________________________________________

Create a NeeS based on an eCTD (Duration: 1 hr, Code: S_NEES_01)

• What Is NeeS?
• Differences to eCTD
• TOC documents & configuration
• Export & post-export modifications

DOCmanager2 (Duration: 2 hrs, Code: S_DM2_01)

• Concept
• Template Dossiers
• Creation & Update of child dossiers

____________________________________________________________

RLPmanager (Duration: 2 hrs, Code: S_RLP_01)

• Concept
• Studies
• Use of Studies in eCTDs

____________________________________________________________

MiniDMS feature of eCTDmanager (Duration: 2 hrs, Code: S_MINI_01)

• Concept
• Document life cycle
• Versioning

____________________________________________________________

Creating Hyperlinks in eCTDmanager (Duration: 2 hrs, Code: S_HL_01)

• Manual creation of hyperlinks
• Automatic resolution of broken links
• "Create hyperlinks from text"
• Hyperlinks and document lifecycle
• Hyperlink Review Mode

____________________________________________________________

Enhanced Printing & Publishing in eCTDmanager (Duration: 2 hrs for participants of the basic training, 4 hrs for beginners, Code: S_PUB_01)

• Publishing basics / repetition
• Format Template concept
• Re-usability for Format Templates
• Printers (requirements)
• ePaper
• Xerox Job Tickets

____________________________________________________________

Publishing Server in eCTDmanager (Duration: 2 hrs, Code: S_PUB_02, can only be booked after S_PUB_01)

• Publishing Server

____________________________________________________________

ePaper functionality in eCTDmanager (Duration: 2 hrs, Code: S_PUB_03, can only be booked after S_PUB_01)

• ePaper ToC documents
• Bookmarks in ePaper
• ePaper and RLPmanager
• ePaper Publishing

PSUR (Duration: 1 hr, Code: S_PSU_01)

• Definition PSUR
• PSUR structure and content
• eCTDmanager & PSUR

____________________________________________________________

CTA/IMPD (Duration: 1 hr, Code: S_CTA_01)

• Definitions
• CTA/IMPD content
• Realisation in eCTDmanager

eCTDmanager technical training (Duration: 4-8 hrs, depending on specific requirements, Code: S_TECH_01)

• eCTDmanager architecture & installation scenarios
• Supported databases
• Archives (file system, DMS)
• Configuration of publishing server
• Notification service

____________________________________________________________

Create AttributeTypeDescriptors for eCTDmanager (Duration: 1 hr (+ customer-individual configuration), Code: S_TECH_02)

____________________________________________________________

eCTDmanager Basic Configuration using the eCTDmanager.exe.config (Duration: 1 hr (+ customer-individual configuration), Code: S_TECH_03)

____________________________________________________________

EURS Multi-DB configuration (Duration: 2 hrs with hands-on, Code: S_EDB_01)

• How to configure EURS with multiple databases

____________________________________________________________

EURS Automation Engine (Duration: 2 hrs, Code: S_EAE_01)

• Concept
• Command line parameters
• Use-cases and benefits for EURS admins