Introduzione
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.
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 Regulatory Information Management (RIM) and electronic submissions. He is a subject matter expert in RIM, eCTD, xEVMPD and ISO IDMP.
Additionally, he is also an active member of EMA ISO IDMP Task Force for Organizations (OMS) and Products (PMS); Chair of Medicines for Europe Telematics group; and Vice-President of the IRISS Forum, a global, open, multidisciplinary, non-profit networking organisation for life science professionals by life science professionals.
Jeanneke Spruit
Jeanneke has over 4 years of experience in the Life Sciences Consultancy Industry. Her experience centers around regulatory information management, with IDMP as a focus. This experience ranges from data compliance assessment to data standard or RIM system implementations, at small- to large-sized pharmaceutical companies. In these projects, her involvement spans multiple domains from defining user requirements for a RIM system to developing regulatory business glossaries and providing IDMP training.
Moreover, Jeanneke brings experience in working with Regulatory Information Management Systems, XEVMPD maintenance, OMS maintenance, Regulatory Intelligence, and Regulatory planning in an acquisition/divestment context.
Online Training – 1 module
02 October 2024 from 09:00 am to 01:00 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 11 September 2024)
Ordinary: € 640,00*
Freelance – Individual – Academy – Public Administration**: € 435,00*
*for Italian companies: +22% VAT
**Early Bird discount not applicable to Freelance – Individual – Academy – Public Administration fee
The fee includes: tuition, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
Registrati
Francesca Archetti
Marketing & Sales Specialist
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.