Qualification Course: EU Regulatory Affairs Manager

Access and procedure

Once you have registered for this course, we will send you the access information for your customer portal. Click here to log in to the customer portal using your email address and password. Please ensure you can access the customer portal before the day of the event.

All important or additional information and personal documents are available in your personalised customer portal. This is also where you start your online courses.

Starting on 26 March 2025, you will have access to the two e-learnings "Introduction to EU Marketing Authorisation" and "EU Variation System and Procedures". You can start your e-learning in the customer portal by clicking "Participate" directly in the respective e-learning. You will then be redirected to the learning platform.

The live-online-seminars "Marketing Authorisation Procedures in the EU" on 9 April 2025, "Marketing Authorisation Documents in the EU" on 8 and 9 May 2025, as well as "Regulatory Lifecycle Management" on 4 June 2025, can be also accessed via your customer portal.

Your benefits

• In-depth knowledge of EU regulatory framework and marketing authorisation procedures
• Insights into the roles and functions of relevant authorities and committees
• Strategies for mutual recognition and decentralised procedures
• Detailed understanding of the centralised procedure and scientific advice process
• Specific information on data exclusivity, innovation protection and requirements for generics
• Detailed knowledge of the CTD structure and specifications for Modules 1-5
• Key elements and structure of the SmPC and package leaflet
• Practical insights into compiling nonclinical and clinical data
• An understanding of eCTD principles, document requirements and submission
• Strategies to avoid common errors and align with authority expectations
• All post-approval activities covered
• Interactions between the PV, regulatory affairs and labelling departments throughout the lifecycle

Technical requirements

You need a reliable Internet connection to take part in our online events. To have the best possible learning experience, we recommend that you use the latest version of the Microsoft Edge or Google Chrome browsers. You will need a headset, loudspeaker or telephone to play the audio. Further information is available here. Please check beforehand that your microphone or headset and camera are working properly. Do not access our services from a VPN since there are issues with the audio over such connections.

We have integrated Zoom video conferencing software into our Learning Space for our online training courses. If you are not authorised to use Zoom, please get in touch with us so we can make alternative arrangements for you to take part in our online training.

Free pre-meeting and technology check

You can attend one of our pre-meetings and explore our Learning Space free of charge. Registration is not required. You can find available dates for a pre-meeting in your customer portal. Click the green ‘Participate’ button in the pre-meeting in the customer portal and you will be redirected to the Learning Space.

The pre-meeting gives you the opportunity to explore our Learning Space and to familiarise yourself with the technology to start off your online training on the right foot. This is a non-binding offer for all our customers and not a prerequisite for participation. If a pre-meeting date does not suit you but you would still like a technology check, please contact us.