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 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
  • 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.

 

Participants’ experience

From beginner to basic understanding of Regulatory Affairs and Data Management.

 

Interactive presentation

Docente/i
Remco Munnik
Info

Remco Munnik

Director at Deloitte

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.
Dennis Verhaegh
Info

Dennis Verhaegh

Senior Consultant at Deloitte

Dennis holds over 4 years of experience in the Life Sciences Consultancy Industry. His main focus area is IDMP and data management. Projects around IDMP range from assessment to implementations, at small- to large-sized pharmaceutical companies. In these projects, his involvement spans multiple domains, from designing business processes, assessing and proposing the technology landscape, to providing IDMP training and awareness sessions.
Moreover, Dennis brings experience in working with Regulatory Information Management Systems, Global Labeling management systems (Product Information, SmPC, CCDS), change control systems, xEVMPD maintenance, OMS maintenance, supporting the IRISS IDMP Topic Group, and EU Medical Device Regulation.

Online training in 1 module:

October, 5th 2023         09:00 am – 01:00 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: € 495,00* (until 14/09/2023)

Ordinary: € 625,00*

Freelance – Academy – Public Administration**: € 375,00*


* 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.

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Versione Stampabile
Cosa saprai fare dopo il corso
Risultato atteso
Have an overview of the EMA telematics landscape
Risultato atteso
Understand the different electronic data submissions that exist at EMA
Risultato atteso
Understand how effective data management will help an organization/department to meet the requirements of EMA
<p><span>Online interactive training on Zoom platform. </span></p> <p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>

Online interactive training on Zoom platform. 

LS Academy will provide the access link to the virtual platform a few days before the training.

<p><span>Online interactive training on Zoom platform. </span></p> <p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>
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Electronic Submissions and Data Management in Regulatory Affairs