About
This training course will provide you with the ins and outs of electronic submissions, covering topics such as eCTD, xEVMPD, PLM eAF, EMA SPOR/IDMP, ESMP and an update on EMA Telematics; what EMA is working on and what we can expect in the (near) future. A deep dive into these topics will answer questions on what the EMA PLM eAF portal is, what future developments will be in this portal, what the timelines are and how it relates to EMA SPOR, its IDMP adoption program and other initiatives at EMA.
In addition, the course will explore in more detail how to manage the data used in these submissions/applications and how to use this information as an organization to gain business value.
This course will help you understand and gain insight into the current landscape of electronic submissions for applications and other obligations. It will provide an overview of what is coming in the EU regulatory landscape. And finally, what is needed to set up data management and how effective data management in an organization will help to meet the challenges upcoming.
- Introductions
- EMA Telematics Update
- Deep-dive into data submissions: eCTD, xEVMPD, PLM eAF, EMA SPOR/IDMP, ESMP
- Deep-dive into regulatory data management and governance
- Closing
This course is aimed at individuals working in the Regulatory Affairs/Operations department and/or involved with Data Management practices in that department or in the organization.
Interactive presentation.
Lecturers
Remco Munnik
Remco holds more than 25 years of experience in Life Science and Regulatory Affairs. With more than a decade dedicated to consultancy around Regulatory Information Management (RIM) and electronic submissions, he has established himself as a prominent figure in the industry. He is a highly-regarded speaker, passionately sharing his insights on eCTD, ISO IDMP, and the importance of a data-driven way of working.Remco’s influence extends into numerous organizations where he actively participates and holds leadership roles. These include Medicines for Europe, where he serves as the Chair of the Regulatory Data & Digital Systems (ReDDS) group; he is President of the IRISS Forum: a global, open, multidisciplinary, non-profit networking organisation for life science professionals by life science professionals; and Remco is a member of the Regulatory Optimization Group (ROG) where EMA, HMA and industry come together.
Online Training – 1 module
05 June 2025 from h.02:00 to h.06:00 pm CEST
Some days before the online training 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: € 495,00* (until 15 May 2025)
Ordinary: € 640,00*
Freelance – Individual – Academy – Public Administration: € 435,00*
*for Italian companies: +22% VAT
The fee includes: tuition, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
Register
Printable Version
At the end of the training, you will be able to
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.