Regulatory Operations - The Digital Imperative
Strategies for a data-driven regulatory landscape
- Intensive 2 half-day sessions
- Practical updates on IDMP, eCTD 4.0, ePI, and AI
- Real-world use cases
- Officially certified according to ISO 9001 and 21001
Series (completed)
Ab
1.290,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 1.290,-€ zzgl. MwSt.
The participation fee includes downloadable documentation, a certificate, access to the Learning Space and technical support including PreMeeting.
Period:
each from 9:00 - 12:30 CET
Buchungsdetails
Series (completed)
Ab
1.290,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 1.290,-€ zzgl. MwSt.
The participation fee includes downloadable documentation, a certificate, access to the Learning Space and technical support including PreMeeting.
Period:
each from 9:00 - 12:30 CET
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.
Referenten
Sebastian Bergmann
STADA Arzneimittel AG,
Bad Vilbel, GERMANY
Head Global RAMACA Systems & Regulatory Operations
Your speaker
Sebastian Bergmann
STADA Arzneimittel AG,
Bad Vilbel, GERMANY
Head Global RAMACA Systems & Regulatory Operations
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,…
Your speaker
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…
Your speaker
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.
What to Expect
- Data quality, interoperability & data governance in Regulatory Affairs
- AI, automation & digital transformation in Regulatory Operations
- IDMP, SPOR & the evolution of data sources
- eCTD 4.0 & ePI - the new submission and product information landscape
- Future trends & strategic positioning of Regulatory Operations
Who Should Attend
This seminar is aimed at professionals working in the field of regulatory affairs and regulatory operations, as well as adjacent roles involved in regulatory systems and processes. It is also relevant for professionals in quality assurance, pharmacovigilance, and data management who work at the interface of regulatory submissions and digital transformation.
Participants are expected to have a solid understanding of EU regulatory procedures.
Objective of the Event
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.
Your Benefit
- You gain a thorough understanding of data quality, governance, and structured content management as key enablers for regulatory automation and AI
- You learn how AI, workflow automation, and cloud-based RIM platforms are reshaping Regulatory Operations today
- You receive a detailed update on IDMP, SPOR services, and the decommissioning of XEVMPD, including practical readiness steps
- You explore the eCTD 4.0 timeline, ePI implementation roadmap, and their impact on submission and labelling processes
- You discuss future competencies and the evolving strategic role of Regulatory Operations with experienced practitioners
Programm
Each day 09:00 - 12:30 CET
Day 1
Sebastian Bergmann, Christine Hirt
- Data quality as the number 1 success factor in Regulatory Affairs
- Impact of data quality on RIM performance
- Structured Content Management (SCM) - the gold standard for automation and AI-readiness
- Data governance: Roles, responsibilities, and cross-functional ownership
- Measuring and improving your data maturity
Sebastian Bergmann, Gürtay Altinok
- AI in Reg Ops: What actually works today?
- The role of structured data in AI-readiness
- Workflow and document automation
- Enterprise system integration
- Cloud-based RIM platforms: Opportunities, data security considerations, and vendor trends
Christine Hirt
- XEVMPD vs. ISO IDMP
- EMA SPOR services: Current status and interdependencies
- IDMP readiness: Aligning your product data with ISO IDMP standards
- Implementation for critical medicines
- PMS submissions: Deadlines, data maintenance, and lifecycle impact
- Decommission of XEVMPD
Day 1
Data Quality & Interoperability
Data Quality & Interoperability
Sebastian Bergmann, Christine Hirt
- Data quality as the number 1 success factor in Regulatory Affairs
- Impact of data quality on RIM performance
- Structured Content Management (SCM) - the gold standard for automation and AI-readiness
- Data governance: Roles, responsibilities, and cross-functional ownership
- Measuring and improving your data maturity
AI, Automation & Digital Transformation
AI, Automation & Digital Transformation
Sebastian Bergmann, Gürtay Altinok
- AI in Reg Ops: What actually works today?
- The role of structured data in AI-readiness
- Workflow and document automation
- Enterprise system integration
- Cloud-based RIM platforms: Opportunities, data security considerations, and vendor trends
Coffee Break
IDMP, SPOR & the Evolution of Data Sources
IDMP, SPOR & the Evolution of Data Sources
Christine Hirt
- XEVMPD vs. ISO IDMP
- EMA SPOR services: Current status and interdependencies
- IDMP readiness: Aligning your product data with ISO IDMP standards
- Implementation for critical medicines
- PMS submissions: Deadlines, data maintenance, and lifecycle impact
- Decommission of XEVMPD
End of Day 1
Day 2
Gürtay Altinok
- eCTD 4.0 timeline: Where do we stand? (EU, PMDA, FDA)
- Key changes: FHIR-based structure, document re-use, SPOR integration
- ePI: Pilot results, implementation roadmap, and labeling impact
- Use of PMS-Data in ePI
- Organizational readiness and transition planning
Sebastian Bergmann, Gürtay Altinok, Christine Hirt
The discussion session can be tailored to the topics most relevant for the participants. Possible focus areas include:
- The evolving role of Regulatory Operations: From document management to strategic data hub
- Impact of the EU Pharmaceutical Legislation reform on Reg Ops processes
- Global convergence: How ICH, FDA, EMA, and emerging markets are aligning on digital standards
- Beyond RA: Cross-functional coordination with other departments
- Skills of the future Reg Ops professional: What competencies will you need?
Sebastian Bergmann, Gürtay Altinok, Christine Hirt
- Real-world example: IDMP implementation for critical medicines
- Participants use cases and open group discussion: Participants are invited to share a challenge or use case from their own practice which will be discussed together
Day 2
eCTD 4.0 & ePI - New Submission & Product Information Landscape
eCTD 4.0 & ePI - New Submission & Product Information Landscape
Gürtay Altinok
- eCTD 4.0 timeline: Where do we stand? (EU, PMDA, FDA)
- Key changes: FHIR-based structure, document re-use, SPOR integration
- ePI: Pilot results, implementation roadmap, and labeling impact
- Use of PMS-Data in ePI
- Organizational readiness and transition planning
Panel Discussion: Future Trends & Strategic Positioning
Panel Discussion: Future Trends & Strategic Positioning
Sebastian Bergmann, Gürtay Altinok, Christine Hirt
The discussion session can be tailored to the topics most relevant for the participants. Possible focus areas include:
- The evolving role of Regulatory Operations: From document management to strategic data hub
- Impact of the EU Pharmaceutical Legislation reform on Reg Ops processes
- Global convergence: How ICH, FDA, EMA, and emerging markets are aligning on digital standards
- Beyond RA: Cross-functional coordination with other departments
- Skills of the future Reg Ops professional: What competencies will you need?
Coffee Break
Use-Cases & Group Discussion
Use-Cases & Group Discussion
Sebastian Bergmann, Gürtay Altinok, Christine Hirt
- Real-world example: IDMP implementation for critical medicines
- Participants use cases and open group discussion: Participants are invited to share a challenge or use case from their own practice which will be discussed together
End of Day 2
Workshops
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.
Downloads
Request the documents using our form.
Brochure
List of abbreviations "Drug Regulatory Affairs and CMC"
More information
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.
Access to and procedure for online events
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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Further Information
List of abbreviations pharma & healthcare
Many abbreviations are used in pharma & healthcare. Download the list of the most important ones.
DEMO-Account e-Learning
Try out our e-Learning programmes free of charge and without any obligation.
Qualification Course Regulatory Affairs Manager
Expand your competencies in drug regulatory affairs in a practice-oriented manner with up to 30% price advantage.
Your Contact Person
We are happy to advise you personally and individually.
Jean-Marie Bayhurst
Conference Manager
+49 6221 500-685
j.bayhurst@forum-institut.de