Day 3 - October 24th 2024Thursday, 24 October 2024 - CET/CEST (Cent Europe Summer, GMT+2)

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Conference Registration

08:00 - 08:30

Conference Registration

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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?
Increasing the value of data – how does it help?
- How to improve decision making?
  - Provide meaningful and correct data insights
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

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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.

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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

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End of Day

15:15 - 15:20

End of Conference

Day 3 - October 24th 2024Thursday, 24 October 2024 - CET/CEST (Cent Europe Summer, GMT+2)

Day 3 - October 24th 2024Thursday, 24 October 2024 - CET/CEST (Cent Europe Summer, GMT+2)

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