Trends and Strategies
Webcode 25112504
Inka Heikkinen
Lundbeck, DENMARK
Regulatory Policy Lead
Dr. Ulrich Granzer
Granzer Regulatory Consulting & Services GmbH, Munich, GERMANY
Dr Granzer is the CEO of Granzer Regulatory
Consulting & Services GmbH, Munich, and thus acts
as an independent consultant for drug development
and drug approval.
More information please click here.
Andreas Lindackers
IQVIA Commercial GmbH & Co. OHG, Neu-Isenburg, Germany
Evidence Strategy Lead Real-World Evidence Solutions
Remco Munnik
IRISS Forum, SPAIN
President; Remco has over 20 years of experience in Regulatory Affairs, with a special focus on Global submission procedures, electronic submission and regulatory data management. He has been directly involved in the development and roll-out of the EU Telematics environment and has in-depth knowledge of the systems. Key areas of expertise include:Regulatory submissions (new MAA to variations), Global eCTD submission, Regulatory Information Management systems (RIM), xEVMPD and ISO IDMP
Anna Kispál
LORENZ Life Sciences Group, Frankfurt a. Main, GERMANY
Product Manager
Dr. Gabriele Wirtz
Bayer AG, Wuppertal, Germany
Global Regulatory Strategist
Melanie Geukes
Bayer AG, Wuppertal, Germany
Global Regulatory Strategist
Dr. Rüdiger Faust
UCB BIOSCIENCES GmbH, Monheim, GERMANY
Policy and Intelligence Lead, Regulatory Community Excellence
25-26/11/2025
25-26/11/2025
Day 1: 09:00 - 17:00 Day 2: 09:00 - 12:00
online
online
Veranstaltung - 1,590 € 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 - 1,590 € 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 online conference offers compact expert talks and diverse perspectives on global regulatory strategies, digital transformation and evidence generation. Expect focused insights, practical takeaways and lively discussions with experienced speakers - and stay informed about the latest developments in global regulatory practices.
This conference offers a comprehensive overview of the latest trends and strategies in global regulatory affairs. Designed for regulatory professionals, it addresses collaborative regulatory pathways such as JSC, ACCESS, ORBIS and OPEN, alongside strategic approaches to global evidence generation from DARWIN EU to FDA. Digital transformation is a central theme, with updates on ISO IDMP, the rollout of eCTD 4.0 and the evolution of clinical trial standards through ICH E6(R3) and M11 - explored from a real-world perspective. The agenda also includes practical insights into global lifecycle management beyond ICH regions and the use of AI in global regulatory intelligence. Through expert-led sessions, participants will gain the knowledge and skills to navigate the complexities of global regulatory environments and stay ahead of emerging trends and challenges.
09:00 Opening Remarks: Introduction of Speakers (Day 1) and Participants
09:15
Inka Heikkinen
10:30 Coffee break
10:45
Dr. Ulrich Granzer
12:00 Lunch break
13:00
Andreas Lindackers
14:45
15:00
Remco Munnik
16:00
Anna Kispál
09:00 Opening Remarks: Introduction of Speakers (Day 2)
09:15
Melanie Geukes, Dr. Gabriele Wirtz
10:30 Coffee break
10:45
Dr. Rüdiger Faust
12:00 End of Day 2
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.
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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