Webcode 25122510
Gürtay Altinok
STADA Arzneimittel AG, Bad Vilbel
Head of IT Regulatory Als Leiter der IT Regulatory Abteilung bei STADA ist Herr Altinok verantwortlich für die RIM-Plattform sowie weiterer zentraler regulatorischer Systeme - etwa der Formulierungsdatenbank und des Publishing/Validierungssystems. Mit über 20 Jahren Projektleitungserfahrung, davon 12 Jahre im anspruchsvollen Pharmabereich, verantwortet er die Implementierung, Wartung und den reibungslosen Betrieb dieser Systeme in enger Zusammenarbeit mit den jeweiligen Fachbereichen.
Sebastian Bergmann
STADA Arzneimittel AG, Bad Vilbel
Head Regulatory Operations;
Als Leiter der Abteilung Regulatory Operations bei STADA überwacht Sebastian Bergmann die Planung, Implementierung und Einführung von RIM-Systemen. Als Experte für strukturiertes Content-Management, Regulatory Intelligence und Regulatory Information Management wandelt er komplexe und unstrukturierte Daten in anwendbare und wiederverwendbare Informationen um. Herr Bergmann hat mehr als 10 Jahre Beratungserfahrung und 5 Jahre Industrieerfahrung, ist zertifizierter Projektmanager (PMP), Business Analyst (PBA) und Scrum Master.
More information please click here.
Christine Hirt
MAIN5 GmbH & Co. KGaA, Frankfurt
Management Consultant Christine Hirt ist Management Consultant und verantwortlich für das Regulatory Business Consulting bei MAIN5. Sie bringt mehr als 20 Jahre Erfahrung im Bereich Regulatory Affairs mit und gilt als international anerkannte Expertin für Regulatory Business sowie die eCTD/XEVMPD/IDMP-Richtlinien. Zusätzlich ist sie in verschiedenen Fachgremien wie DIN/ISO TC/WG6, IRISS, BPI und MEGRA aktiv. Frau Hirt berät sowohl Behörden als auch die Industrie auf ihrem Weg zu eCTD, IDMP und RIMS.
08/12/2025
08/12/2025
09:00 am - 5:00 pm
online
online
Veranstaltung - 1,290 € zzgl. MwSt.
The participation fee includes downloadable documentation, a certificate of attendance, access to the Learning Space and technical support including a pre-meeting session.
Veranstaltung - 1,290 € zzgl. MwSt.
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
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.
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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