Gürtay Altinok
STADA Arzneimittel AG, Bad Vilbel
Head of IT Regulatory; As Head of the IT Regulatory Department at STADA, Mr. A 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.
Sebastian Bergmann
STADA Arzneimittel AG, Bad Vilbel, GERMANY
Head Global RAMACA Systems & Regulatory Operations
More information please click here.
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.
08/12/2025
08/12/2025
09:00 am - 5:00 pm
you may dial in 30 min before start of seminar
online
online
Event - 1,290 € plus tax
The participation fee includes downloadable documentation, a certificate of attendance, access to the Learning Space and technical support including a pre-meeting session.
Event - 1,290 € plus tax
The participation fee includes downloadable documentation, a certificate of attendance, access to the Learning Space and technical support including a pre-meeting session.
Verena Planitz
Conference Manager
+49 6221 500-655
v.planitz@forum-institut.de
This seminar provides a comprehensive overview of RIM and IDMP requirements, system challenges and best practices. It also explores the role of AI, cloud solutions and future trends in regulatory information management. Participants will gain practical insights to optimise processes and prepare for upcoming regulatory developments.
This seminar provides an in-depth understanding of international and regional regulatory requirements for RIMS, including the role of IDMP. It addresses the challenges of introducing and maintaining RIM systems, presents best practices for data management and compliance, and explores the use of new technologies such as AI, cloud solutions and automation. In addition, participants will discuss future trends and strategic developments, ensuring a well-rounded perspective on current and upcoming RIM topics.
09:00 Welcome and Technical Warm-up
09:15
Gürtay Altinok
10:20 Coffee Break
10:30
Christine Hirt
12:00 Lunch Break
13:00
Gürtay Altinok, Sebastian Bergmann
14:00
Gürtay Altinok, Sebastian Bergmann, Christine Hirt
14:30 Coffee Break
14:45
Gürtay Altinok, Sebastian Bergmann
15:45
Gürtay Altinok, Sebastian Bergmann, Christine Hirt
16:15
Christine Hirt
17:00 Closing Remarks
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