Registration and Networking
Welcome

Martin Schmid, CEO (EXTEDO)

Navigating the Future: Current Trends in Regulatory Information Management, AI, and Automation

Steve Gens (Gens & Associates)

Regulatory Round-the-World Tour: Discovering Global Regulatory Updates

Dr. Gerhard Neurauter (EXTEDO)

Podium Discussion: Latest Developments and Challenges in Regulatory Information Management

Steve Gens (Gens & Associates), Schei Dattner (EXTEDO)

Networking Coffee Break
eCTD 4.0 and the Evolution of Structured Data Submissions

Kristiina Puusaari (EMA), Anjana Pindoria-Rettenberger (EXTEDO)

IDMP Progress: Regulatory Framework, Current Status, Challenges, and Global Outlook

Dr. Jörg Stüben (Boehringer Ingelheim International GmbH), Dr. Anna Thaidigsmann (EXTEDO)

Digital Transformation in Egypt: The EDA's Vision of a Healthier Tomorrow

Dr. Ali El-Ghamrawy (EDA)

Transforming Healthcare: Seamless End-to-End Health Authority Solutions and Processes at the EDA
Dr. Eman Hussein (EDA), Andrea Obermeyer (EXTEDO)
Optimizing Industry-Agency-Collaboration using Structured Content with Related Annotations

Christian Mehrmann (Rote Liste Service GmbH), Andrea Obermeyer (EXTEDO)

Networking Buffet Lunch

Break-Out Sessions

Break-Out Session

including a Networking Coffee Break at 15:15

14:15-14:45 How AWS is shaping the future of Healthcare and Life Sciences with Generative AI Dr. Krishna Singh (AWS)

14:45-15:15 AI Unveiled: Exploring the Next Interface for Human-Data Interaction Anjana Pindoria-Rettenberger, Andrea Striebel (EXTEDO)

15:45-16:15 Global Updates on Electronic Product Information (ePI) Regulations and Insights to the EMA ePI Pilot Paul Kamm (Rote Liste Service GmbH)
16:15-16:45

Journey of the Structured Data and Stakeholder Collaboration for ePI - From Pharma to Patient Podium discussion

Break-Out Session

including a Networking Coffee Break at 15:15

14:15-14:45 Navigating the Transition from eCTD 3.2 to eCTD 4.0 with Confidence Dr. Hebatallah Ibrahim (EDA), Anjana Pindoria-Rettenberger (EXTEDO)

14:45-15:15 Revolutionizing Content Creation: The Future of Structured Component Authoring with Master Data Management (MDM) Niklas Jänich (Boehringer Ingelheim), Janet Schorr (Docuvera)

15:45-16:15

Regulatory Transformation in the MENA Region: Progress, Challenges, and Future Outlook Dr. Mona Al Moussli (PRA Consultancy)

16:15-16:45 From Collaboration to Empowerment: argenx’s Journey from relying on external publishing support to Independently Managing Submissions with an End-to-End Partner Veerle De Bruyker (argenx)

 

End of Official Part Day 1
Evening Event and Dinner
View Day 2