*Short Courses require an additional registration fee. You do not need to be registered for the forum to attend*
This Short Course will be offered virtually – Join from anywhere! During this short course the instructors will introduce you to the systems that applicants will have to interact with and which are critical on your road to an EU filing. This will include an overview of the various EU portals, EMA IT systems, data management initiatives and electronic procedures (e.g. IRIS, CTIS, DADI).
Registered attendees for this virtual Short Course will receive access to the course recording for 2 full months post-course! This allows you to remain flexible with your schedule and not worry if you need to step out momentarily. Have a conflict with the dates of the course, but are interested in the content? Register anyway and you will receive access to the recording!
Receive $150 off your forum registration by registering for any combination of at least two short courses and/or primers as well as the main forum. Purchases must be made at the same time to receive the discount. Discounts will be reflected on the last page of the cart.
Upon completing this course, attendees will be able to:
- Explain the different EMA IT and data management systems and their role
- Identify the various EU portals to perform relevant submissions (e.g. a Scientific advice request, a clinical trial application, a marketing authorization application including an electronic application form)
- Discuss how to perform XEVMPD submissions and how to use EVWEB
- Recognize the (near) future state of the EMA IT landscape due to the introduction of SPOR and DADI
Regulatory Submissions, Information, and Document Management Forum
Regulatory Content and Submission Primer: Content from Authoring to Archive
Preconference Short Courses
Short Course: The Future of Documents: Deep-Dive into Structured Content