eSubmissions: Update on all telematics projects and the impact on regulatory processes and companies
This two-day master class will 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.
At the end of the training, you will be able to:
- Understand the current state, latest developments and the future in Telematics area.
- Assess the impact the eSubmission roadmap has on your organization and
- prepare yourself and your company for the (near) future, eSubmission requirements.
eCTD has been implemented as the international standard for dossier submissions.
In Europe eCTD is the mandatory format for submission since January 2019.
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 these Telematics projects and impact on Industry. Moreover it will provide insight on the latest developments, from direct interactions with EMA and NCAs.Download the programme
This masterclass is organized by LS Academy and the lecturer is Remco Munnik.More information and subscribe