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