Introduzione
It is a challenge to keep up-to-date with the details of the EU Regulatory Telematics environment. Besides electronic Common Technical Document (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), SPOR Master Data Management project and electronic Product Information (ePI).
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 National Competent Authorities (NCAs).With all these developments and ongoing activities, this course becomes a 3x3 hour online 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 Regulatory Information Management (RIM) solutions and company requirements.
Module 1: EU Telematics strategy
Module 2: Dossier preparation
- eCTD
- Submission (EAF, CESP and Gateway)
Module 3: Regulatory Information Management
- xEVMPD
- SPOR
- ISO IDMP
Regulatory Affairs, Regulatory Operations, IT responsible, Pharmacovigilance
Participant experience
At least 1-2 years’ experience in Regulatory Affairs and/or Regulatory Operations.
Interactive training on the latest eSubmission projects to create the effective telematics roadmap
Docente/i
Remco Munnik
Remco holds more than 20 years of experience in Life Science and Regulatory Affairs, including more than a decade providing consultancy around Rinvolving Regulatory Information Management (RIM) and electronic submissions. As a recognized figure in the field, his Subject Matter Expertise spans across dossier and data management (eCTD, xEVMPD and ISO IDMP).
Besides the SME, Remco has experience with Clinical development, CMC writing, Regulatory, Quality and Pharmacovigilance.
Remco’s influence extends into numerous organizations where he actively participates and holds leadership roles. These include Medicines for Europe Telematics group, where he serves as the Chair of the Regulatory Data & Digital Systems (ReDDS) group group; and President of the IRISS Forum, a global, open, multidisciplinary, non-profit networking organisation for life science professionals by life science professionals.
Online training – 3 modules
October 20th, 2020 2.30 pm – 5.30 pm CEST
October 22nd, 2020 2.30 pm – 5.30 pm CEST
October 27th, 2020 2.30 pm – 5.30 pm CEST
After the registration, you will receive all details about the connection.
The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
Early Bird: € 1.320,00* (until 29 September 2020)
Ordinary: € 1.420,00*
Freelance – Academy – Public Administration**: € 792,00*
* for Italian companies: +22% VAT
**Early Bird discount not applicable to Freelance – Academy – Public Administration fee
The fee includes: tuitions, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
Newsletter
Cosa saprai fare dopo il corso
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.
