This site is part of the Informa Connect Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 3099067.

Global Pharmaceutical Regulatory Affairs Summit
21-23 October 2025
Hotel Palace BerlinBerlin, DE
Menu
keyboard_arrow_right

Day 3 - October 24th 2024

keyboard_arrow_leftSearch & Filter
search
Day 3 - October 24th 2024
search
Showing 1 of 1 Streams
09:00 - 09:10
Chair’s opening remarks: Global eSubmissions
  • Rakesh Neelam - Sr Specialist- Digital Innovation & Systems - Regulatory Planning & Publishing, MSD
09:10 - 09:55
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
09:55 - 10:40
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
Showing 1 of 1 Streams
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
Showing 1 of 1 Streams
13:40 - 13:45
Chairperson’s Afternoon Remarks: Global eSubmissions
  • Rakesh Neelam - Sr Specialist- Digital Innovation & Systems - Regulatory Planning & Publishing, MSD
13:45 - 14:45
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
Day 2 - October 23rd 2024
Filter
Streams
Clear
Formats
Choose Day