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.

Regulatory Basics

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 

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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

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

  • Centralized Procedure
  • National Procedure
  • MRP/DCP

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

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

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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

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

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

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

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

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

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

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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

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

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

Dossier Management

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

  • The MRP Goal
  • Business Case
  • Software Solution

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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

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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

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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

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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

 

eCTDmanager Enhancements

DOCmanager2 (Duration: 2 hrs, Code: S_DM2_01)

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

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RLPmanager (Duration: 2 hrs, Code: S_RLP_01)

  • Concept
  • Studies
  • Use of Studies in eCTDs

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

  • Concept
  • Document life cycle
  • Versioning

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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

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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

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

  • Publishing Server

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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

Regulatory Information

PSUR (Duration: 1 hr, Code: S_PSU_01)

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

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

  • Definitions
  • CTA/IMPD content
  • Realisation in eCTDmanager

Technics

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

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

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

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

  • How to configure EURS with multiple databases

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

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

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