Including legislative updates on the CMA and the new pharma package
Webcode 26122604
Frank Dickert
EXTEDO GmbH, Ottobrunn, GERMANY
Senior Business Consultant After an apprenticeship in the pharmaceutical industry, Frank Dickert graduated with a degree in biochemistry, focussing on bioinformatics and structural biochemistry. In 2017, Frank Dickert joined EXTEDO's Regulatory Competence Center. Since then, he has been consulting pharmaceutical companies in regulatory business as well as eCTD submissions and IDMP worldwide. He analyzes and optimizes regulatory business processes and document lifecycles with or without software, resolves customer support issues with different eSubmission tools, and offers regulatory consulting regarding the respective tool.
Gabriele Eibenstein M.A.
-requested- Senior Expert in Regulatory Affairs, Bonn, GERMANY
Senior Expert in Regulatory Affairs Ms Eibenstein has extensive expertise in European procedural management, heads the specialist field "RAS, AM counterfeiting, supply shortages" at BfArM, is the German member of the SPOC Working Party, and is actively involved in shortage management at both national and European levels.
03 - 04/12/2026
03 - 04/12/2026
each from 9:00 a.m. - 12:30 a.m. CET:
online
online
Event - 1,290€ plus tax
The participation fee includes downloadable documentation, a certificate, access to the Learning Space and technical support including PreMeeting.
Event - 1,290€ plus tax
The participation fee includes downloadable documentation, a certificate, access to the Learning Space and technical support including PreMeeting.
Jean-Marie Bayhurst
Conference Manager
+49 6221 500-685
j.bayhurst@forum-institut.de
Stay up to date on EU supply shortage management: reporting obligations, the Critical Medicines Act and practical ESMP guidance - in two focused half-day sessions.
This online seminar provides a comprehensive overview of supply shortage management in the EU - from regulatory obligations to practical tools.
In module 1 you will gain a solid understanding of the EU shortage monitoring landscape, including key reporting obligations for MAHs at EU and national level, the role of EMA, NCAs and the SPOC network, and the implications of the Critical Medicines Act and the new EU pharma legislation for shortage management.
In module 2 you will explore the ESMP in depth - its data structure, the three monitoring scenarios and practical guidance on correct data submission, including API-based automated reporting.
Both modules will be recorded and made available to you after the event for flexible review.
03.12.2026 09:00 - 12:30
Gabriele Eibenstein M.A.
04.12.2026 09:00 - 12:30
Frank Dickert
Are you interested in broadening your regulatory horizon? This seminar can be booked as part of the qualification course 'Regulatory Affairs Manager', which provides a structured introduction to regulatory affairs while allowing you to set your own focus areas. It combines guided self-study with interactive online seminars to build a solid understanding of regulatory requirements for human medicinal products. Core principles of EU marketing authorisation form the foundation, with the option to deepen your knowledge through additional online trainings.
Search for the webcode 60012501 on our website for more information and registration or simply click on the link below:
Qualification Course Regulatory Affairs Manager
By booking the qualification course you will save up to 30% compared to individual bookings.
Both modules will be recorded and made available to the participants afterwards.
This gives you the opportunity to revisit the content flexibly and at your own pace or to review specific topics whenever needed. In this way, the training can be integrated smoothly into your working routine. The recordings will be available for up to 90 days after the live sessions.
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.
Once you have registered for an event, 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. If you do not have access to the customer portal yet, you can easily register here.
On the day of the event, you kick off your online training in the customer portal by clicking ‘Participate’ directly in the respective event. You will then be redirected to the Learning Space.
Learn more about our online events here.
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