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Day 3 - October 24th 2024 - CET/CEST (Cent Europe Summer, GMT+2)
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Day 3 - October 24th 2024 - CET/CEST (Cent Europe Summer, GMT+2)
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Global eSubmissions
09:00 - 09:10
Chair’s opening remarks: Global eSubmissions
09:10 - 09:40
Cloud based Agency Interactions: Project PRISM
- Understanding set up and intention
- Results of Phase 1
- Use cases currently in testing
- Outlook
- Jörg Stüben - Head of Regulatory Information Management and Senior Expert, Boehringer Ingelheim International GmbH
09:40 - 10:10
Cloud Based Submissions: Accumulus State of Play
- Latest updates from Accumulus Synergy
- Current status of cloud based technology
- Industry interaction and current pain points
- Latest updates and developments
- The future of cloud: is there no turning back?
- Ali Hansford - Director of Regulatory Innovation Strategy & Policy (Europe), Accumulus Synergy
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Global eSubmissions
11:10 - 12:40
Exploring AI Potentials: Industry Case Studies and Future Perspectives
II. Case Study 1: The Role of Artificial Intelligence in Translation
A. Generative-AI as a Solution for Multilingualism in Europe and Beyond
- The Concept and Impact of Suggestive Translations
B. Impact of AI on The Industry
- Improving the Efficiency of Translation vs Potential Mistakes
- Job Security Concerns: The Risks of AI to Human Roles
- Future Perspectives: Expansion of AI in Translations and Its Impact on Global Submissions
III. Case Study 2 Leveraging Generative AI for Dossier Writing
A. The Rising Importance of Generative-AI in Pharma
- Opportunities for Simplifying the Dossier and Submission Process
- Section Writing
- Responding to Questions from Regulators
- Risks Involved in Using Generative-AI in Dossier Writing
- Rakesh Neelam - Sr Specialist- Digital Innovation & Systems - Regulatory Planning & Publishing, MSD
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Global eSubmissions
13:40 - 13:45
Chairperson’s Afternoon Remarks: Global eSubmissions
13:45 - 14:15
Spotlight Session: Navigating Pharmaceutical Regulations with Expert Guidance
Please contact: Linda Cole – linda.cole@informa.com
Or Call +44 (0)2080520405 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar.
14:15 - 15:00
Navigating Global Submissions: What Does The Future Hold?
- With eCTD 4.0 being adopted more widely, what is next for submissions?
- Can industry expect further amendments or versions to specifications?
- How do regulators see future alignment of specifications?
- How can stakeholders further collaboration to enhance working best practices?
- How do manufacturers prepare and upskill teams to meet the changing landscape of submissions?
- How much more entwined will submissions and RIM become?
- Anna Sokołowicz - Director, e-Submission Strategy and Process, GSK
- Teresa Eastwood-Kiefer - Regulatory Data and Content Chapter Leader, Roche
- Rakesh Neelam - Sr Specialist- Digital Innovation & Systems - Regulatory Planning & Publishing, MSD
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