Trends and Strategies
Webcode 26092511
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
Arcana Life Science Consulting, S.L.
Independant Consultant in Regulatory Information Management; Remco has recently taken on the role of independent consultant as the founder and owner of Arcana, bringing over 20 years of deep expertise in Life Sciences and Regulatory Affairs. With more than a decade of consultancy experience, he has led initiatives in Regulatory Information Management (RIM) and electronic submissions, earning recognition as a trusted expert in the field. His subject matter expertise encompasses dossier and data management, including eCTD, xEVMPD, and ISO IDMP, positioning him as a strategic partner for regulatory transformation and compliance. Remco's influence extends into numerous organizations where he actively participates and holds leadership roles. These include Medicines for Europe, where he serves as the Chair of the Regulatory Data & Digital Systems (ReDDS) group; he is President of the IRISS Forum: a global, open, multidisciplinary, non-profit networking organisation for life science professionals by life science professionals; and Remco is a member of the Regulatory Optimization Group (ROG) where EMA, HMA and industry come together. Remco strongly believes that innovation in the Life Sciences sector does not solely rely on waiting for the next significant breakthrough or a fortunate turn of events. His vision is built on the conviction that innovation is best fostered by cultivating a proactive attitude. This involves taking strategic, incremental steps that evolve into data-driven leaps, propelling us towards unprecedented discoveries and superior innovation. This proactive, calculated approach not only expedites our progress but also paves the way for ground-breaking advancements.
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
Dr. Isabelle Stöckert
Independent Regulatory Science Expert
Dr. Stöckert has extensive experience in global pharmaceutical development, collaborating closely with the FDA and EMA.
Mark Gray
Keine kurze englische Beschreibung vorhanden
Keine ausführliche englische Beschreibung vorhanden
17 - 18/09/2026
17 - 18/09/2026
Day 1: 09:00 - 17:00 Day 2: 09:00 - 12:00
online
online
Event - 1,590€ 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 - 1,590€ 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 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
Dr. Isabelle Stöckert
10:30 Coffee break
10:45
Dr. Ulrich Granzer
12:00 Lunch break
13:00
Andreas Lindackers
14:45 Coffee break
15:00
Remco Munnik
09:00 Opening Remarks: Introduction of Speakers (Day 2)
09:15
Mark Gray
10:15 Coffee break
10:30
Melanie Geukes, Dr. Gabriele Wirtz
11:45 - 10:45
Dr. Rüdiger Faust
13:00 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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