eCTD has been implemented as the international standard for dossier submissions. In Europe eCTD has been slowly brought as the mandatory format for submission.
eCTD in EU is already mandatory for a lot of activities, but the next deadlines for mandatory use of eCTD are reflected in the EU Telematics roadmap:
July 2018: new MAA in NP (human)
January 2019: All submissions (human) in CP, DCP, MRP and NP
Besides eCTD, many other eSubmission projects are ongoing, including: electronic Application Form (eAF), Common European Submission Plaform (CESP), the EMA Gateway, eXtended Eudravigilance Medicinal Product Dictionary (XEVMPD), ISO Identification of a Medicinal Product (IDMP) and SPOR project.
This course will explain the history, current state and outlook of eCTD mandatory use and the impact on Industry. Moreover it will provide insight on the latest developments, from direct interactions with EMA and NCAs, including an outlook on the future situation of the Telematics environment.
With all these developments and ongoing activities, this course become a two-day master class and bring you up-to-date with all you need to know with regards to the roadmap and strategy of eSubmission and what you have to consider from an organizational point of view for your company.
If you’re responsible for Regulatory Affairs, you might not have the time or resources to be aware of all developments, changes and update on the Telematics eCTD, eAF, CESP, xEVMPD, SPOR and ISO IDMP.
To get up-to-date, this course will put the attention on what are the issues to think about for getting ready including possible RIM (Regulatory Information Management) solutions and company requirements.
To whom it may concern
- Regulatory Affairs
- Regulatory Operations
- IT responsible
At least 1-2 years experience in Regulatory Affairs and/or Regulatory Operations
– ICH and regional specifications
– Theory and practice of eCTD
– Mandatory use of eCTD on global level
- Submission portals (CESP and Gateway)
- eAF and CESSP
- ISO IDMP
– Regulatory Optimization
– Electronic SmPC and PIL
– RIM solution
- IT tools to assist in the preparation of companies
Type of Training
- Theoretical training of the latest eSubmission projects
- Demo of tools that can assist companies
- Overview and preparation for a Regulatory Information Management System
At the end of the training, you will be able to:
understand the current state, latest developments and the future in Telematics area. Afterwards you will be able to assess the impact the eSubmission roadmap has on your organization and prepare yourself and your company for the (near) future, eSubmission requirements
Remco Munnik, Regulatory Information Director, Asphalion S.L., Barcelona
Remco has a Bachelor degree in a study of Management, Economics & Law. He has over fifteen years’ experience in Global submission procedures, electronic submission (focus EU and US) and regulatory data management. Since 2011 Remco works for Asphalion, an international Regulatory Affairs consultancy, based in Barcelona and Munich. Within Asphalion, Remco is responsible for global eSubmission projects (eCTD, NeeS, RIM, xEVMPD and ISO IDMP). His team is working on CP/DCP/maintenance for EU and FDA (IND/NDA/BLA/maintenance). In addition a dedicated team is focussed on xEVMPD submission and IDMP implementation. In addition he is the chairman of Medicines for Europe Telematics working group and in direct contact with EMA and NCAs for the eSubmission roadmap, eCTD specification, validation criteria, eAF, CESP, Gateway, xEVMPD, SPOR and ISO IDMP.