21-23 October 2025
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Day 3 - October 24th 2024
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Day 3 - October 24th 2024
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Showing 1 of 1 Streams
Conference Registration
08:00 - 08:30
Conference Registration
Showing 2 of 2 Streams
Regulatory Information Management and Digital Transformation
Global eSubmissions
09:00 - 09:10
Chair’s opening remarks: Regulatory Information Management and Digital Transformation
- Luisa Heesen - Business Data Domain Owner Products and Substances, Boehringer Ingelheim
09:10 - 09:40
Generating Data-Driven Value for Better Decisions and Operational Excellence - Use Case
- Building the pillars of the data governance
- Starting with small, fix the basics with attainable objectives
- Build stakeholder collaboration and trust
- Focusing on business defined critical data – what is critical?
- Starting with small, fix the basics with attainable objectives
- Increasing the value of data – how does it help?
- How to improve decision making?
- Provide meaningful and correct data insights
- How to improve decision making?
- Technology Enabled Capabilities
- Can we leverage from AI?
- Simplify data management
- Janaki Suriyanarayanan - Senior Manager Regulatory Information Management, Merck KGaA Darmstadt Germany
- Kepa Amutxastegi Gabiola - Associate Director Regulatory Information Management, Merck KGaA Darmstadt Germany
09:40 - 10:10
Aligning RIM and PMS: Challenges for a Systematic Comparison
- Source of truth: RIM vs PMS vs Documents ?
- RIM/FHIR data model differences and comparison format
- How to represent comparison results ?
- Outcome of the comparison: enrichment and correction
- Pierre Stanislawski - Product Director, Ennov
- Maxime Delpire - Regulatory Information Management Expert, Ennov
10:10 - 10:40
Industry Case Study: Enhancing End to End RIM Capabilities
- Key data points when undergoing enhancement of RIM capabilities
- Pros and cons of RIM enhancement
- Impact on regulatory department and wider impact
- Gaining internal buy in
- Digitalization aspect
- Maturing digitized operating model
- Shaping digitized environment
- Impact on wider digital transformation
- Quentin Darrasse - Regulatory Data Strategy Principal, Roche
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
Networking Break
10:40 - 11:10
Networking Break
Showing 3 of 3 Streams
Regulatory Information Management and Digital Transformation
Global eSubmissions
Regulatory Affairs in Global Markets
11:10 - 11:55
Utilising Artificial Intelligence & Machine Learning (AI/ML)
- Current use case: where has AI/ML currently been implemented?
- Which processes is it supporting?
- Which regulations is it adhering to?
- Teething problems and solutions
- Future use cases
- What opportunities are there for AI/ML?
- How can other companies leverage similar approaches?
- Raj Patra - Global IT & Digital Lead - R&D, Safety, PLM, Quality, Regulatory Affairs & Compliance, Reckitt
11:55 - 12:40
IDMP Ontology – Collaborative Implementation of IDMP in Pharma
- Overview of IDMP-O and enabled pharma use cases
- Results and learnings from the EMA PMS Data Alignment PoC enabled with IDMP-O
- Learnings from the IDMP-O Maturity Benchmark Survey: What's needed to be successful with IDMP as a semantic product data backbone?
- Heiner Oberkampf - CEO and Co-Founder, Accurids
- Jörg Stüben - Head of Regulatory Information Management and Senior Expert, Boehringer Ingelheim International GmbH
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
11:10 - 11:20
Chair’s opening remarks: Regulatory Affairs in Global Markets
- Lucie Svobodová - Senior Manager, Regulatory Affairs, Novavax
11:20 - 12:00
Transforming Challenges into Opportunities: Enhancing Patient Access in the Orphan Drug Landscape
- Leveraging Regulatory Pathways for Orphan Drugs
- Integrating Market Access into Regulatory Strategies
- Fostering Patient Engagement in Orphan Drug Access
- Kwee-Lan Tan - Regional Regulatory Lead, Emerging Markets, Boehringer Ingelheim
12:00 - 12:40
Real World Evidence in the LATAM Region
- Current data requirements in LATAM
- What’s new?
- Does each country align?
- Adhering to requirements
- Best practices for regulators
- Resources and contacts for industry
- Yuricel Tamayo Alvarez - Regulatory Affairs Specialist, Roche Ecuador S.A.
Showing 1 of 1 Streams
Lunch
12:40 - 13:40
Lunch
Showing 3 of 3 Streams
Regulatory Information Management and Digital Transformation
Global eSubmissions
Regulatory Affairs in Global Markets
13:40 - 13:45
Chair’s afternoon remarks: Regulatory Information Management and Digital Transformation
- Luisa Heesen - Business Data Domain Owner Products and Substances, Boehringer Ingelheim
13:45 - 14:45
Multi-Stakeholder Panel: RIMs of the Future
- With further digitalisation on the horizon, what does the next 5 years hold for RIM?
- Use of AI
- Tool development
- Workforce skills
- Regulatory needs
- Abita Nanda - Chapter Lead, Regulatory Innovation and Sustainment, Genentech
- Ana Montoya Alarcon - Director Regulatory Systems Lead, Daiichi Sankyo
- Andrea Fischer - Global Head Regulatory Operations – IT Systems & Digital, Sandoz
- Matthias Glatz - Principal Product Manager, Digital for Development, Moderna
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
13:40 - 13:45
Chairperson’s Afternoon Remarks: Regulatory Affairs in Global Markets
- Alan Chalmers - Owner, Pharma International
13:45 - 14:45
Data Collection Across the Globe: A Future Forecast
- Can we expect enhanced regional alignment for data requirements in the future?
- Can industry utilise the same data across regions?
- How can indsutry and regulators work together to improve data collection and submissions?
- Danini Marin - Independent Consultant, Regulatory Affairs
- Nathan Seyoum - Medicine Registration Expert /Co founder and Regional Coordinator, East Africa Regulatory Affairs Professionals Association (EARAPA)
- Kholoud Mohamed - Clinical Technical Support Unit Manager, Egyptian Drug Authority
14:45 - 15:15
Industry Case Study: Dossier Registration in EAEU
- Current experiences with gaining dossier compliance in EAEU
- Comparison with EU registration system
- Areas for consideration when registering pharmaceuticals in the region
- Lessons learned for future applications
- Boris Pleten - Head of Registration Department of the EAEU, Gedeon Ritcher
Showing 1 of 1 Streams
End of Day
15:15 - 15:20
End of Conference
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