Strategies for a data-driven regulatory landscape
Webcode 26112640
Sebastian Bergmann
STADA Arzneimittel AG, Bad Vilbel, GERMANY
Head Global RAMACA Systems & Regulatory Operations
More information please click here.
Gürtay Altinok
STADA Arzneimittel AG, Bad Vilbel
Head of IT Regulatory; As Head of the IT Regulatory Department at STADA, Mr. Altinok is responsible for the RIM platform as well as other key regulatory systems, including the formulation database and the publishing/validation system. With more than 20 years of project management experience, 12 of which in the demanding pharmaceutical sector, he ensures the implementation, maintenance, and smooth operation of these systems in close collaboration with the respective departments.
Christine Hirt
MAIN5 GmbH & Co. KGaA, Frankfurt, GERMANY
Management Consultant & Regulatory Consulting Lead; Christine Hirt is Management Consultant & Regulatory Consulting Lead and responsible for regulatory business consulting at MAIN5. She has more than 20 years of experience in the field of Regulatory Affairs working for industry and authority representatives. Christine is internationally recognized on expert level for regulatory business processes, guidelines and regulations. She is an active member in several associations, such as DIN/ISO TC/WG6, IRISS, BPI and MEGRA. Participating actively in the IDMP adoption expert group of WG6/TC215/ISO and other expert groups associated with implementing RIMS and IDMP.
24 - 25/11/2026
24 - 25/11/2026
each from 9:00 - 12:30 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
Konferenzmanager Pharma & Healthcare
+49 6221 500-685
j.bayhurst@forum-institut.de
This seminar covers the key drivers of digital transformation in Regulatory Operations - from data quality and AI-driven automation to IDMP, eCTD 4.0, and ePI. Across two half-day sessions, you will gain practical strategies and discuss real-world use cases with experienced practitioners.
This intensive seminar spanning two half-day sessions provides a comprehensive overview of the digital transformation in Regulatory Operations. From data quality and AI-driven automation to IDMP implementation and eCTD 4.0, all key aspects of a modern, data-driven regulatory landscape will be addressed.
You will learn how to ensure data quality as the foundation for RIM performance and AI-readiness, and how to leverage automation and cloud-based platforms to streamline your regulatory workflows. You will also gain in-depth knowledge of IDMP/SPOR requirements, the transition from XEVMPD, and the upcoming eCTD 4.0 and ePI frameworks.
Through real-world use cases and interactive group discussions, you will be equipped with practical strategies to position Regulatory Operations as a strategic data hub within your organisation.
09:00 - 12:30 Day 1
09:00 Welcome & Technical Warm-Up
09:15
Sebastian Bergmann, Christine Hirt
10:00
Sebastian Bergmann, Gürtay Altinok
11:00 Coffee Break
11:15
Christine Hirt
11:30 End of Day 1
09:00 - 12:30 Day 2
09:15
Gürtay Altinok
10:00
Sebastian Bergmann, Gürtay Altinok, Christine Hirt
11:00 Coffee Break
11:15
Sebastian Bergmann, Gürtay Altinok, Christine Hirt
12:30 End of Day 2
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.
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.
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