eSubmission Manager in Europe
eSubmission and database requirements in 2019
- eSubmission - Regulatory update
- XEVMP, 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
Aims and objectivesThis seminar will familiarise you with electronic submission requirements in regulatory affairs and enable you to further professionalise your submission management. It will also identify the data you need for IDMP and SPOR and show you how to optimise your data integrity management.
Day 2: 09:00 - 17:00
- The EU Telematics Strategy (2020-2025)
- Submission of electronic dossiers (new submission, variation and renewal)
- Submission portals: CESP, CESSP and EMA eSubmission Gateway
- Creation of delivery files and eAF
- Optimising submission management
11:00 Coffee break
- XEVMPD, how much longer?
- The transition to IDMP/SPOR
- EMA Master Data Management Roadmap
- The upcoming IDMP draft implementation guide
- SPOR concept
- What data has to be collected?
15:30 Coffee break
- 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?
17:00 End of day 1
- Registration planning and tracking
- Submission management
- Document management
- Label management
- Structured authoring
10:30 Cofee break
- 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
- Role of a business user in IT projects
- Computer system validation
- User requirement specification
- User acceptance testing
- Lessons learned from IT projects in regulatory affairs
- Overview of available systems and vendors
- Cloud systems
14:45 Coffee break
17:00 Seminar ends
Regulatory Information Director
Nähere Informationen finden Sie hier.
NL 1054 Amsterdam
Phone: +31 20 6075555
Fax: +31 20 60075511
Please send us your questions concerning the seminar topics in advance. We will be happy to forward them to the speakers, so that they know about your training requirements even better and are able to answer your questions at the seminar. Please send your questions to Jessica Hüske: email@example.com
Do you lack CTD/eCTD expertise (including CMC know how for CTD module 3)? Then, we would recommend the 'Common Technical Document & eCTD' e-learning programme.
This e-learning programme will provide you with detailed knowledge on the structure and content of the (electronic) common technical document - the only valid dossier format for marketing authorisation applications for human pharmaceuticals in the ICH region.
It will address full as well as abridged dossier application formats, enabling participants to select the data necessary for each application type. Module 3 requirements will be addressed in depth (drug substance and drug product data requirements).
The e-learning programme 'Common Technical Document & eCTD' comprises four didactic modules that include videos in which the experts Lidia Cánovas and Michael Schaub shares their expertise with you. You can also download and print the corresponding presentation documents.
Each module comprises additional documents (links, guideline texts, etc.) as well as interactive exercises and questions, which help you practise and apply your newly gained knowledge.
Once you have completed the four modules and passed a final multiple-choice test, you will be awarded a certificate, which you can print out directly. The e-learning programme should be completed within three months. Try our e-learning programme for free and familiarise yourself with our learning environment.
Please register for the seminar "eSubmission Manager in Europe" by clicking '"Register"'. You will receive a €100 discount if you also book the e-learning programme (you will be billed €490 + local VAT rather than €590 + local VAT).