22-24 October 2024
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Day 2 - October 23rd 2024 - CET/CEST (Cent Europe Summer, GMT+2)
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Day 2 - October 23rd 2024 - CET/CEST (Cent Europe Summer, GMT+2)
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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
08:30 - 08:40
Chair’s opening remarks: Regulatory Information Management and Digital Transformation
- Patrick Middag - Principal Regulatory Affairs Lead, Servier
08:40 - 09:10
International Update: Global Substance Registration System (G-SRS)
- Defining ‘global’ substance registration – is it actually global?
- How closely aligned are FDA and EMA’s initiatives?
- Current work by the FDA
- Current status of software development
- Current priorities of system development
- In Europe, what are the initial learnings from the EU-SRS roll out?
- Lawrence Callahan - Chemist, FDA, USA
- Marcel Hoefngel - Assessor, Biopharmaceuticals, College ter Beoordeling van Geneesmiddelen - Medicines Evaluation Board (CBG-MEB)
09:10 - 09:55
International Update: GIDWG and Global Identifiers
- GIDWG
- GIDWGs role in the global IDMP landscape
- Updates
- Global PhPIDs
- Updates
- Global substances
- Global collaboration on substances, in different forums
- Where are we now?
- Olof Lagerlund - Substance Expert, Uppsala Monitoring Centre
- Isabel Chicharo - Head of Regulatory Data Management Service, EMA
09:55 - 10:40
Electronic Application Forms (eAF): Where does Web eAF fit in with intended Target Operating Model?
- Latest proposals on process for using Web eAF to maintain PMS data
- How does PMS get updated on approval?
- Managing parallel variations
- Managing changes where no eAF is required
- Alastair Nixon - Senior Director, Data Strategy, GlaxoSmithKline Research & Development Limited, UK
- Veronica Lipucci Di Paola - Master Data Manager at European Medicines Agency, EMA
08:30 - 08:40
Chair’s opening remarks: Global eSubmissions
- Suzie Henderson - Associate Director, Regulatory Affairs, Shionogi Europe
08:40 - 09:25
eCTD in Europe: Where Are We Now?
- Current status of adoption throughout Europe: including UK and Switzerland
- On-going work: which countries are next in the pipeline?
- Upcoming revisions to eCTD
- How harmonised are already adopted countries?
- The future: is there a version beyond 4.0?
- Kristiina Puusaari - eSubmissions Programme Management, EMA
09:25 - 10:10
Navigating the Global eCTD Landscape: Insights from Asia and Africa Implementation Journeys
- Global eCTD landscape overview – eCTD implementation progress
- How are countries in APAC adopting eCTD and current digitalization status in the region
- What is the eCTD state of play in African countries
- Alignment in expectations versus implementation challenges
- Anna Sokołowicz - Director, e-Submission Strategy and Process, GSK
- Andreas Skarpis - Senior Submissions Manager, Roche
10:10 - 10:40
Data Driven Submissions through AI & Structured Content Authoring
Bobby will discuss the ongoing transformation of the life sciences regulatory space, and how your organization can execute efficiently and effectively against short-term initiatives that will serve longer term strategic deliverables.
With the challenges that surround IDMP, KASA, and the use of FHIR standards come unique opportunities to accelerate transformation and tangible advantages in regulatory.
- Bobby Bouthillette - Global Director, Quality & Regulatory, Dassault Systèmes
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 - 11:40
AI Powered RIM & Submission Process Concept
Leveraging generative AI, LORENZ introduces a concept to further enhance RIM and submission management. By combining technical compliance validation with AI-powered content checks from sources such as historic submissions, RIM data, and external data (e.g., SPOR), the concept envisions reducing errors and enhancing data and submission quality through advanced automation.
- Anna Kispál - Product Manager, LORENZ Life Sciences Group
- Rainer Schwarz - Business Consultant, KlearDoc/ LORENZ Life Sciences Group
11:40 - 12:40
A Novel Approach of Addressing Data and Process Questions in Platform Implementations
- Part 1: The Data flow map
- E2E data flow along the product lifecycle for selected business scenarios
- E2E data flow across systems and functions
- Delivering the visualized value chain of data
- Part 2: Overcoming Master data challenges when implementing a system platform approach across various functions
- Main challenges in a complex setting
- Real world examples
- Holistic oversight of a Data Integration Manager as key
- Luisa Heesen - Business Data Domain Owner Products and Substances, Boehringer Ingelheim
- Michael Kempf-Hamm - Senior Manager Data & Process Integration, Boehringer Ingelheim
11:10 - 12:00
eCTD: Ukranian Update
- Latest specification update on eCTD 3.2.2 in Ukraine
- Alignment with other regions
- Expectations for regulators and indsutry alike
- Experiences of submitting within the region
- Lessons for future implementation
- Dmytro Lurye - Project Manager, Medicines for Europe
12:00 - 12:40
Harvesting and Using Real World Evidence (RWE) – Public, Private Partnerships to Bridge to Regulatory Requirements
- Defining real world evidence
- Do definitions harmonisation across Europe and the US?
- Methods of collecting, storing and analysing RWE
- How do you ensure data is sufficient and support submission messaging?
- The future of evidence
- Can we expect further integration of this type of data into submissions?
- How can teams pivot to meet the demands of RWE and related submission changes?
- Jesper Kjær - Global Director for Public, Private Partnerships, StratOps, Global Medical Affairs, Novo Nordisk, Denmark
11:10 - 11:15
Chair’s opening remarks: Regulatory Affairs in Global Markets
- Anna Hanzlíková - Senior Director, Global RA, Regulatory Head, Europe and ROW, NOVAVAX CZ a.s.
11:15 - 11:55
Advancing APAC’s Advanced Therapies
- With more focus being placed on rare diseases, what are APAC’s current regulatory requirements and pathways for market access?
- Current availability of advanced therapies in the region
- Comparison to other global regions
- Working example: gaining approval for advanced therapies in APAC
- Upcoming developments and future plans
- Anna Litsiou - Regulatory Policy & Intelligence Director - International & China, AstraZeneca
11:55 - 12:40
MENA & Rare Disease: Update on Regulatory Requirements
- Latest regulatory landscape for advanced therapies across MENA
- How aligned are pathways across the region?
- Expected timeline from product to patient
- Current challenges with approval
- Shaping the future
- Collaboration across countries and regions
- On-going development work
- Qutaiba Al Manaseer - Government Affairs Director, AstraZeneca
Showing 1 of 1 Streams
Lunch
12:40 - 14:00
Lunch
Showing 3 of 3 Streams
Regulatory Information Management and Digital Transformation
Global eSubmissions
Regulatory Affairs in Global Markets
14:00 - 14:10
Chair’s afternoon remarks: Regulatory Information Management and Digital Transformation
- Patrick Middag - Principal Regulatory Affairs Lead, Servier
14:10 - 15:00
Developing Data Governance Strategies
- Reviewing data governance within the organisation
- Strengths and weaknesses
- Strategy development process
- Key data points
- Incorporation of IDMP and RIM standards
- Future-proofing data governance strategies and processes
- Martin Steinmann - Developing a Data Governance Strategy, CSL Behring
15:00 - 15:30
AI and Automation in RIM and IDMP: How to Get Started Now
- Building chat-based insights from regulatory dossiers
- Reduction of manual work in Regulatory Operations
- IDMP and data quality on a continuous basis
- Alignment between IDMP data and documents
- Niels Leander - Vice President, R&D Consulting, NNIT
14:00 - 14:10
Chair’s afternoon remarks: Regulatory Guidances and Legislative Landscape
- Suzie Henderson - Associate Director, Regulatory Affairs, Shionogi Europe
14:10 - 14:55
Global Trends on Leveraging Serialisation and Traceability Requirements
- Access to medicines – Explore how traceability supports inventory managment at various points in the supply chain.
- Access to Online Product Information (ePL) - Discuss methods to improve patient access to comprehensive product information online through electronic Product Information Leaflets (ePL).
- Single Unit Dose Packaging: Learn about the benefits of single-unit dosage packaging in enhancing medication adherence and safety for patients.
- Martin Fitzgerald - Director Digital Health and Public Policy Healthcare, GS1
- Geraldine Lissalde-Bonnet - Vice President Healthcare, GS1 Global
14:55 - 15:30
Industry Perspective: Structured Content Authoring
- Alessandra Sech - Regulatory Operations Manager, Tiefenbacher Group
14:00 - 14:10
Chair’s afternoon remarks: Regulatory Affairs in Global Markets
- Alan Chalmers - Owner, Pharma International
14:10 - 14:40
eLabelling Practices and Trends in APAC
- Current initiatives across the region
- Most accepting markets
- Hurdles to consider
- Enhancing eLabelling in the region
- Plans for further roll out
- Jianhui Sun - Regulatory Affairs Manager APAC Region, SEPTODONT
14:40 - 15:30
LATAM Landscape for Advanced Therapies
- Regulatory state of play across LATAM for rare diseases
- Are regulatory pathways aligned?
- Current approval timelines across the region
- Challenges with current approval pathways
- The future in LATAM: how can further alignment be achieved?
- Mario Alanis, PhD - Senior Advisor, CIRS - Centre for Innovation in Regulatory Science
Showing 1 of 1 Streams
Networking Break
15:30 - 16:00
Networking Break
Showing 3 of 3 Streams
Regulatory Information Management and Digital Transformation
Global eSubmissions
Regulatory Affairs in Global Markets
16:00 - 16:30
Curating an Effective Master Data Management Strategy
- Filip Cvetanovski - Regulatory Affairs, ALKALOID AD Skopje
16:30 - 17:00
Assessing and Implementing Fast Healthcare Interoperability Resources (FHIR)
- Current status of FHIR Standards
- Impact on industry – is this compulsory?
- Working example: implementing the messaging format
- Once structured data has been generated, how are companies assessing readiness of XML messaging format?
- Points of assessment
- Tools used
- Lessons learned and best practices moving forward
- Craig Anderson - Director, R&D Labeling Lead, Pfizer
17:00 - 17:45
Multi-Stakeholder Perspective: Piloting Electronic Product Information (ePI)
- With pilots of ePI ongoing, what experiences do we have so far?
- Interaction with EMA during pilots
- Initial learnings and anticipated modifications
- The next stage of ePI for industry and regulators
- Embedding for submissions and IDMP usage
- Global harmonisation expectations
- Digitalization
- Koen Nauwelaerts - Regulatory Policy and Innovation Lead, Bayer
- Anne Moen - Coordinator, Gravitate Health & Professor, University of Oslo
- Elizabeth Scanlan - Scientific Communication Officer & ePI Product Owner, European Medicines Agency (EMA)
- Hannie de Munnik - Executive Director EUCAN Regulatory Affairs, AstraZeneca
16:00 - 16:30
Evolving Role of the Publisher in a Data-driven Biopharmaceutical Company Using the Strengths of an Asynchronous Organization
- Why asynchronous working with a colourful personality team is an asset for future publishing teams
- From paper, to electronic, to structured data submissions; the role of a publisher has changed throughout the last decade. In addition to our day-to-day publishing activities, Jazz's INSPIRE Publishing team is pivotal to user management and data-stewardship. Join this session to gain insights on how an asynchronous working team becomes an asset, and how they collaborate within a multidisciplinary team to create processes for: web-based XEVMPD submissions, data stewardship (PLM & SPOR portals), IRIS submissions and user management
- Jolanda de Bruijn - Senior Manager, Global Regulatory Operation, Jazz Pharmaceuticals
16:30 - 17:00
Digital Transformation in EAEU & CIS Regulatory Field
- Regulatory Updates in CIS and Convergence into Digital
- Impact on Global RA, PV, GMP Procedures from Digitalisation
- Insights into Future Digitalisation Roadmap in the CIS
- Polina Dombure - CEO, Inpharmatis Group
17:00 - 17:45
The Big Picture Panel: Aligning Data to Documents
- How do we get data and documents closer together?
- Impact of closer alignment on regulators and industry
- Future of data & documents
- Remco Munnik - Vice President, IRISS Forum
- Mustafa Ghafouri - Lead Data Architect, Doctor Data
16:00 - 17:45
Advanced Therapies of the Future: A Global Perspective
- Analysing learnings from the day, how can regions enhance collaboration for advanced therapy regulation?
- What is needed to expedite these pathways?
- Future impact of enhanced collaboration
- Timeline from product to patients
- Wider public health
- Impact on manufacturers and regulators
- Belinda Mudhobhi - Pharmaceutical Innovation Strategy and Regulation Specialist, AfricaBio
- Anna Litsiou - Regulatory Policy & Intelligence Director - International & China, AstraZeneca
- Thomas Kirchlechner - Director Regulatory Policy & Intelligence, Sandoz
Showing 1 of 1 Streams
End of Day
17:45 - 18:45
End of Day 2 and Networking Drinks, Sponsored by Ennov
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