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Advanced Level Training Courses
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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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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