TRAINING | eSubmission Manager in Europe
eSubmission and database requirements in 2020
The course provides practical, hands-on experience in eCTD specifications, eSubmission requirements and data integrity for IDMP, SPOR and XEVMPD.
He will speak about the following subjects:
eSubmission – Regulatory update
- XEVMPD, IDMP, SPOR: Efficient data maintenance and integrity
- Regulatory information management
- eSubmission and the various purely national requirements in Europe
- IT know-how for eSubmission managers
eSubmission – Regulatory Update
- The EU Telematics Strategy (2020-2025)
- Submission of electronic dossiers
- Submission portals: CESP, CESSP and EMA eSubmission Gateway
- Creation of delivery files and eAF
- Optimising submission management
- Electronic product information
eSubmission and the various purely national requirements in Europe – How to master this balancing act
XEVMPD – Efficient data maintenance
- XEVMPD, how much longer?
- The transition to IDMP/SPOR
IDMP & SPOR
- EMA Master Data Mgmt. Roadmap
- The upcoming IDMP draft implementation guide
- SPOR concept
- What data has to be collected?
Implementation of IDMP – Hands-on tips
- Preparation of the required data
- GAP analysis and strategies for IDMP implementation in the enterprise
- Smart IDMP: What benefits does IDMP bring to my company?
Hands-on eCTD: Frequent dossier preparation problems and possible validation problems
- Case studies for discussion and experiences with the EU Module 1 specifications
- eCTD 4.0 (next major version)
- Existing dossiers: Conversion to eCTD in the life cycle
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