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)

Global Updates on Electronic Product Information (ePI) Regulations and Insides to the EMA ePI Pilot

Paul Kamm (Rote Liste Service GmbH)

Shaping a New, Seamless Tomorrow - From Submission Preparation to Patient from One Single Source

Peter Koop (Bertelsmann Next - Digital Health), Oliver Bosch (EXTEDO)

Networking Buffet Lunch

Break-Out Sessions

Break-Out Session

including a Networking Coffee Break at 15:00

14:00-14:30 AI and Data for good - better data, better insights, better outcome Dr. Krishna Singh (AWS)

14:30-15:00 AI Unveiled: Exploring the Next Interface for Human-Data Interaction Anjana Pindoria, Andrea Striebel (EXTEDO)

15:30-16:00 Transforming Healthcare: The Vision of Seamless End-to-End Health Authority Solutions and Processes
16:00-16:30 Sharing Experiences: Bridging Information Management Challenges Between Industry and Regulators

Break-Out Session

including a Networking Coffee Break at 15:00

14:00-14:30 eCTD 4.0. Forward Compatibility and Implementation Plans Globally

14:30-15:00 Revolutionizing Content Creation: The Future of Structured Component Authoring with Master Data Management (MDM) Niklas Jänich (Boehringer Ingelheim), Janet Schorr (Docuvera)

15:30-16:00 Regulatory Transformation in the MENA Region: Progress, Challenges, and Future Outlook 

16:00-16:30 From Collaboration to Empowerment: argenx’s Journey from relying on external publishing support to Independently Managing Submissions with an End-to-End Partner

 

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