21-23 October 2025
Hotel Palace BerlinBerlin, DEkeyboard_arrow_right
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Day 1 - October 22nd 2024
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Day 1 - October 22nd 2024
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Streams
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Showing 1 of 1 Streams
Conference Registration
08:00 - 08:30
Conference Registration
Showing 3 of 3 Streams
Regulatory Information Management and Digital Transformation
Regulatory Guidances and Legislative Landscape
Regulatory Affairs in Global Markets
08:30 - 08:40
Chair’s opening remarks: Regulatory Information Management and Digital Transformation
- Jörg Stüben - Head of Regulatory Information Management and Senior Expert, Boehringer Ingelheim International GmbH
08:40 - 09:25
Implementation in Europe
- How far ahead is IDMP implementation within Europe?
- Current regulatory framework
- Available guidance and resource
- Next steps for IDMP in Europe
- Future collaboration with other global regulators and alignment of frameworks
- Laurent Desqueper - IT Regulatory Affairs & QA, UCB
- Isabel Chicharo - Head of Regulatory Data Management Service, EMA
09:25 - 10:10
IDMP in non-EU Countries: Switzerland & UK
- Status update on IDMP in Switzerland & UK
- How closely aligned to EMA’s implementation strategy and framework are they?
- Working groups’ current priorities
- On-going digitalisation work
- The next 5 years of IDMP in non-EU countries
- Catherine Russell - Data Architect (Taxonomy), Medicines and Healthcare Products Regulatory Agency (MHRA)
- Andreas Fürer - Regulatory Manager, SwissMedic
10:10 - 10:40
Beyond Technical Readiness: IDMP’s Impact on the Operating Model, Organization, and Data Governance Structure
- IDMP is multidimensional: Technical readiness is one piece; operational models, organization design, and data governance structures must adapt.
- People, Process, Technology, and Data components:: Prioritize key areas and create a clear future state roadmap.
- Governance structure that supports change: Enable cross-functional collaboration, defining key roles and responsibilities to drive the IDMP transition.
- Paul Attridge - VP Vault RIM, Enterprise, Veeva
- Edoardo Gnavi - Senior R&D Business Consultant, Veeva Systems
08:30 - 08:40
Chair’s opening remarks: Regulatory Guidances and Legislative Landscape
- Andrew Deavin - Senior Director, Global Regulatory Affairs, GSK
08:40 - 09:40
A Deeper Look: The Revision of European Pharmaceutical Regulation
- Orphan Drug development provisions
- Data Exclusivity compared to the current legislation and its impact on pharmaceutical companies
- Regulatory provisions: EMA committees, assessment time, Platform technology approaches
- How can industry – and other stakeholders - prepare for implementation
- Maren von Fritschen - Head Regulatory Policy EU, Moderna
- Matthias Heck - Head of EU Government Affairs & Strategic Alliance Development, Alexion Pharmaceuticals
- Balázs Lázár - Head of Global Regulatory CMC & Operation Department, Gedeon Richter
09:40 - 10:10
Facilitating the Digital Transformation of Module 3 to PQ/CMC, IDMP and ICH M4Q R2
In an increasingly regulated and data-driven industry, the digital transformation of Module 3 to align with PQ/CMC, IDMP, and ICH M4Q R2 standards is an important initiative and opportunity for pharmaceutical companies. This presentation will explore how industry expertise combined with advanced technologies, can enhance the reliability and trust (transparency, completeness, correctness, and timeliness). This will increase efficiency and accuracy during the creation, as well as the assessment of regulatory dossiers. By leveraging digital tools and technology-driven methodologies, pharmaceutical professionals can optimize their processes, reduce errors, and achieve better and faster decisions. The need in the pharmaceutical industry will be backed by recent industry survey results conducted by Celegence articulating some of the challenges and opportunities.
Participants will learn how to:
1. Apply best practices for streamlining Regulatory submissions -- how you can simplify and accelerate the preparation and submission of Module 3 documentation in compliance with PQ/CMC, IDMP, and ICH M4Q R2 guidelines
2. Enhance data integrity - utilizing digital solutions to ensure that data across systems and documents is consistent, reliable, and ready for regulatory scrutiny.
3. Navigate digital transformation challenges -- strategies for successfully implementing computer assisted assessments in the regulatory processes, including global regulatory impact assessment.
- Hans van Bruggen - Chief Scientific Officer, Celegence
10:10 - 10:40
Multi-Stakeholder Perspective: Defining Gene Therapy Medicinal Product (GTMP)
- Maren von Fritschen - Head Regulatory Policy EU, Moderna
09:30 - 09:40
Chair’s opening remarks: Regulatory Affairs in Global Markets
- Kristina Bayramyan - Director, Regulatory Policy, Emerging Markets, GSK
09:40 - 10:40
Global Markets and Reliance: Where Are We Now?
- With reliance being a consistent conversation, what progress has been made to date?
- Which countries share reliance pathways?
- Has this increased work sharing?
- Are pathways more efficient?
- Wider impact
- Industry's workload
- Medicine availability
- Next steps for reliance
- Lawrence Liberti - Director, The D. K. Kim International Center For Regulatory Science
Showing 1 of 1 Streams
Networking Break
10:40 - 11:10
Networking Break
Showing 3 of 3 Streams
Regulatory Information Management and Digital Transformation
Regulatory Guidances and Legislative Landscape
Regulatory Affairs in Global Markets
11:10 - 12:10
IDMP from Industry’s Perspective: How Are They Coping?
- With multi-country IDMP initiatives coming to fruition, what are the opportunities and challenges for industry:
- Managerial support
- Investment in IDMP
- Data and process readiness in line with other data sets
- Moving forward
- Company's plans for further work
- Areas for regulators to address
- Morad Tahani - Associate Director - IT Lead Regulatory, UCB
- Suzie Henderson - Associate Director, Regulatory Affairs, Shionogi Europe
- Raj Patra - Global IT & Digital Lead - R&D, Safety, PLM, Quality, Regulatory Affairs & Compliance, Reckitt
- Eileen Flood - Associate Director, Business Outcomes Delivery (Regulatory Information Management), Johnson & Johnson
- Mustafa Ghafouri - Lead Data Architect, Doctor Data
12:10 - 12:40
Current State of Play: ICH M4Q
- Latest updates of ICH M4Q from the working group
- Outcomes from multi-stakeholder consultation
- Current focuses and on-going work
- Applications for industry
- Is it compulsory?
- The future of ICH M4Q
- Laurent Lefebvre - Regulatory CMC Director, Novartis Pharma AG
11:10 - 11:40
Exceptional Authorisations during Pandemic and Transition to Standard Registrations
- Mapping out registration pathways for Covid-19 vaccines during pandemic, comparison of EMA, FDA, WHO and other global agencies approach
- Outlining core similarities and differences for the exceptional use pathways compared to standard ones
- Key steps and requirements for transition to standard authorisations
- Anna Hanzlíková - Senior Director, Global RA, Regulatory Head, Europe and ROW, NOVAVAX CZ a.s.
11:40 - 12:10
The EU AI Act: Implications for Industry
- EU AI Act Governance
- Preparation for implementation
- Which stakeholders are involved?
- Can industry get involved? And, if so, how?
- Potential implications for regulators, industry and wider public health
- Ana Padua - Director EU Global Regulatory and Scientific Policy, Merck HealthCare
- Sebastian Fischer - Regulatory Strategy Principal, TÜV SÜD Product Service GmbH
- Aneta Tyszkiewicz - Director Digital and Data, European Federation of Pharmaceutical Industries and Associations (EFPIA)
12:10 - 12:40
Harnessing the Power of Regulatory Sandboxes
- Lessons learned from other industries
- How Regulatory sandboxes can help foster innovation
- Olivia McDermott - Associate Professor in Regulatory Affairs & Operational Excellence, University of Galway
11:10 - 11:55
Spotlight on APAC: Reliance in the Region
- Latest Advancements on reliance and convergence in APAC
- Current available pathways by country
- Comparison to other regional pathways
- Success story: utilising reliance for approval
- Lessons learned and future implications
- Karin Markgraf - Head of Regulatory Affairs Asia Pacific, Merck Group
11:55 - 12:30
Reliance in MENA: The Latest News
- Latest regulatory updates for reliance pathways in the Middle East and Africa
- Impact of such pathways on medicines available in the region
- Current experiences with using reliance pathways
- Challenges and opportunities
- On-going work
- Future plans for further development
- Abdul Mateen - Director, Healthcare Consultancy Services
Showing 1 of 1 Streams
Lunch
12:40 - 14:10
Lunch
Showing 3 of 3 Streams
Regulatory Information Management and Digital Transformation
Regulatory Guidances and Legislative Landscape
Regulatory Affairs in Global Markets
14:10 - 14:15
Chair’s afternoon remarks: Regulatory Information Management and Digital Transformation
14:15 - 15:15
An Atlantic Update: IDMP Implementation in Canada
- Current vocabularies used in Canada
- Best practices for adoption and integration of global standards
- Recent experiences and lessons from with PhPID end to end testing with WHO-UMC
- Alignment with other regions
- Collaboration with international partners and organizations
- Karin Hay - Policy Analyst, Health Canada
- Marcin Boruk - Senior Policy Analyst, Health Canada | Santé Canada
15:15 - 15:45
Electronic Application Forms (eAF): Where Are We Now?
- Latest regulatory update for eAF, timelines for implementation
- Recent modifications to form or upcoming amendments – renaming, copy, review/approval, status
- Industry's current experiences with completing forms in PLM portal
- Alastair Nixon - Senior Director, Data Strategy, GlaxoSmithKline Research & Development Limited, UK
- Kristiina Puusaari - eSubmissions Programme Management, EMA
14:10 - 14:15
Chair’s afternoon remarks: Regulatory Guidances and Legislative Landscape
- Andrew Deavin - Senior Director, Global Regulatory Affairs, GSK
14:15 - 15:00
EU Clinical Trials Regulation 536/2014 and CTIS Two Years into the Transition Period: EORTC’s Experience
- Exploration of staff views prior implementation
- Experience with CTR implementation, focusing on aspects such as:
- Country requirements
- Requests for information
- The Q-IMPD only application
- Jelle Stans - Regulatory Affairs Manager, European Organisation for Research and Treatment of Cancer (EORTC)
15:00 - 15:45
Sustaining the Future: Pharmaceuticals and Environmental Legislation
- What are the current environmental regulatory requirements for manufacturing and distributing pharmaceuticals in Europe?
- How are regulators and industry helping to reduce environmental impact?
- Tracking carbon footprints of shipments, manufacturing, etc...
- Limiting plastic use and increasing reusable materials
- Global initiatives focusing on sustainability
- Ways to get involved
- Upcoming projects
- Qutaiba Al Manaseer - Government Affairs Director, AstraZeneca
14:10 - 14:15
Chair’s afternoon remarks: Regulatory Affairs in Global Markets
- Alan Chalmers - Owner, Pharma International
14:15 - 14:45
The East African Pharmaceutical Regulatory Landscape: Updates on the Region and Harmonisation Initiatives
- Abebe Alamneh, B Pharm, MSc, - Senior Medicine Registration Expert, Ethiopian Food and Drug Authority (EFDA)
14:45 - 15:15
Industry Experience with the WHO Pre-Qualification (PQ) and Collaborative Registration Procedure (CRP)
- Putting reliance principles into practice: Ins and outs of the WHO prequalification (PQ) and collaborative registration procedure (CRP)
- Industry experience with PQ and CRP
- Thomas Kirchlechner - Director Regulatory Policy & Intelligence, Sandoz
15:15 - 15:45
Aligning LATAM: State of Play with Reliance
- Current alignment status of reliance pathways across LATAM
- Comparison to other regions
- Experiences with gaining approval
- Next steps: how can further alignment be achieved?
- Diego Alejandro Gutiérrez Triana - Regional Regulatory Director - Colombia, Udela
Showing 1 of 1 Streams
Networking Break
15:45 - 16:15
Networking Break
Showing 3 of 3 Streams
Regulatory Information Management and Digital Transformation
Regulatory Guidances and Legislative Landscape
Regulatory Affairs in Global Markets
16:15 - 16:45
Reimagine Regulatory with GenAI Technology
Adding Value to Regulatory Operations with GenAI
- As investments in regulatory data capture, enrichment and exchange continue to rise in line with agency mandates, the potential scope for artificial intelligence (AI) and generative AI seems limitless in its promise to transform labour-intensive processes while maintaining high accuracy. But where could this technology deliver tangible everyday benefits?
- In this session, discover two practical GenAI applications that are demonstrating efficiency gains across Health Authority Interactions and Regulatory Intelligence Monitoring.
- Renato Rjavec - Senior Director, Regulatory Product Management, ArisGlobal
16:45 - 17:30
Analysing your migrated data in PMS
- EMA's migration approach: Rules and pitfalls
- Ways of comparing PMS with your internal data sources
- Results and conclusions
- Josef Pellizarri - Managing Director, Pellizzari Consulting GmbH
- Alaitz De Eguía y López - Operations Lead Structured Data Submissions, Sanofi
17:30 - 18:00
UNI-Gone? Life Beyond Unicom
- Final update on the UNICOM project
- Findings from the last 5 years
- Changes or updates to standards as a result of UNICOM
- Wider impact on patients and public health
- Life beyond UNICOM: what can industry expect?
- Christian Hay - Sr Advisor Healthcare, GS1 Global Office
16:15 - 17:00
An Update on the EU Variations Framework Revision
- The story behind the revision
- Updates in the framework
- Future outlook
- Alessandra Leone - CMC Director, I&I, Pfizer
17:00 - 18:00
Looking to the Future: Regulating Pharmaceuticals in Europe
- With legislative reforms on the horizon, how does the future look for pharmaceuticals in Europe?
- Expectations on industry
- Cross-regional harmonisation
- Availability of medicines
- Future-proofing workforces
- Which skills and tools do we expect to become more prevalent in the coming years?
- Can industry and regulators alike prepare for these changes now?
- Maren von Fritschen - Head Regulatory Policy EU, Moderna
- Andrew Deavin - Senior Director, Global Regulatory Affairs, GSK
- Laurent Lefebvre - Regulatory CMC Director, Novartis Pharma AG
- Mustafa Ghafouri - Lead Data Architect, Doctor Data
16:15 - 18:00
Widen Perspectives: Reliance and the Future of Work Sharing
- How does the concept of reliance filter into work sharing and collaboration?
- Could cross-regional work sharing enhance medicine availability and reduce duplicated submission work?
- Future of the workforce
- Preparing teams for enhanced collaboration
- Organisational structuring for optimal working practices
- Lawrence Liberti - Director, The D. K. Kim International Center For Regulatory Science
- Faraat Ali - Manager, Department of Inspection and Enforcement, Laboratory Services, Botswana Medicines Regulatory Authority (BOMRA)
- Zainab Aziz - Associate Director RA Policy and Strategic Operations- SSA, Novartis
- Céline Bourguignon - Head, Greater China and Intercontinental & Emerging Markets Regulatory Policy, GSK
- Kholoud Mohamed - Clinical Technical Support Unit Manager, Egyptian Drug Authority
Showing 1 of 1 Streams
End of Day
18:00 - 18:05
End of Day 1
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