IDMP 2020 - the first iteration!
With practical examples of how to describe your products in IDMP
- Status of implementation
- Details of the IDMP EU Implementation Guide
- Collection, cleaning and structuring of data - your urgent to-dos
- Structured electronic product information (ePl)
- The link between ePl, IDMP and SPOR
Aims and objectivesThe first iteration of IDMP is approaching - high time to implement IDMP. This workshop helps you collect, clean and structure all necessary data, as well as showing you how to build efficient project teams for the implementation.
Related topics, such as SPOR and structured electronic product information, will also be addressed in detail.
Be ready for IDMP iteration 2!
(from 08:30 registration)
- ISO IDMP: motivation and status of implementation
- ISO IDMP essential theory: The data structure and ID's: Pharmaceutical Product Identifier (PhPID), Medicinal Product Identifier (MPID), Packaging ID (PCID)
- ISO IDMP and the potential use in telematics projects (eAF, CESP, TOM)
- Data-elements as requested for Iteration 1 - Review of the mandatory data-elements, including an evaluation of the source and data-management of these fields.
- Which medical product information shall be submitted in the new format
- Pharmaceutical & medicinal product
- Marketing authorisation information
- Therapeutic (product) indication
- Packaged Medicinal Product Identifier (PCID)
- Technical specifications on structure and format
- Migration from XEVMPD to PMS, status
- Describing medicinal products in IDMP, based on examples submitted by participants in advance
- Regulatory data
- PV data
- Production data
- Responsibilities, duties and project leadership
- SPOR necessities
- Do I need master data management?
- Do I need a content management system?
- PMS and data-feeding processes(Art 57 data-feeding processes),TOM (target-operating model)
- IDMP EU Implementation Guide:version 2 forecast for mid-2020
Associate Director; Remco has over 20 years of experience in Regulatory Affairs, with a special focus on Global submission procedures, electronic submission and regulatory data management. He has been directly involved in the development and roll-out of the EU Telematics environment and has in-depth knowledge of the systems. Key areas of expertise include: - Regulatory submissions (new MAA to variations) - Global eCTD submission - Regulatory Information Management systems (RIM) - xEVMPD - ISO IDMP
Head of IT
Phone: 069 2561790
- Two IDMP/SPOR experts
- Authority and industry know-how combined
- IDMP description using your products as practical examples
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 "IDMP 2020 - the first iteration!" 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).
Save the date! Your regulatory update in pharmacovigilance with european drug safety experts and a special network event.
21. - 22.11.2019 in Mannheim
This course will give you an in-depth knowledge on the CMC requirements for the marketing authorisation.
25. - 26.09.2019 in Amsterdam