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.