ESUBMISSIONS: UPDATE ON ALL TELEMATICS PROJECTS AND THE IMPACT ON REGULATORY PROCESSES AND COMPANIES
Get informed about the latest status of all EU projects on electronic submission, ranging from eCTD, eAF, CESP, xEVMPD, SPOR and ISO IDMP
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.
With all these developments and ongoing activities, this course becomes 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 roadmap and impact on processes within your organization.
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.
Date: 22-23 October 2019
Time: 09:30 am – 6:00 pm
Venue: Barcelona, Spain
Cost: Early bird: € 1570* (until 27-08-2019)
Ordinary: € 1780*
Freelance – Academy – Public Administration: € 890*
* For Italian companies: + 22% VAT
The fee includes: tuition, teaching materials, lunches and coffee breaks, office assistance, attendance certificate
Complete booking and payment at this link and use code MVA1908 to book and receive 15% off.
For any further question feel free to contact Mara Claudia Algarotti firstname.lastname@example.org