2023 Europe Interchange Program
Program is subject to change.
All times in Europe Central Time
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All times in Europe Central Time
2023 Europe Interchange Program
9:00 - 10:30
Session 1: Opening Plenary and Keynote Presentation
Nick De Donder, Business & Decision Life Sciences
Vandsalen
9:00 - 9:10
CDISC Welcome
Nick De Donder, Business & Decision Life Sciences
9:10 - 9:25
State of the CDISC Union
Dave Evans, CDISC President and CEO
9:25 - 9:55
State of CDISC Standards
Bess LeRoy, CDISC
9:55 - 10:30
Keynote Presentation: How to Make the Big Data Dream Come True
Dr. Anja Schiel, Team Leader, International HTA (iHTA), Norwegian Medicines Agency (NoMA)
Anja Schiel has studied Biology at the Johannes Gutenberg-University, Mainz, Germany. She received her PhD from the Free University in Amsterdam in 2006 and worked several years as Post-Doc on a range of subjects focusing on oncology, immunology and molecular biology, first at the University of Leiden and later at the University of Oslo, before starting at the Norwegian Medicines Agency (NoMA) in 2012.>
At NoMA she is working as Special Adviser/Statistician/Methodologist both on regulatory (EMA) and HTA projects. She has been Chair of EMA’s Biostatistics Working Party 2017 - 2019 and from 2019 – 2022 she was Chair of the Scientific Advice Working Party (SAWP) at EMA. She continues currently as alternate member of the SAWP and is Member of the new Methodology Working Party (MWP) recently established at EMA.
Since it was established in 2020 she has been a member of the Big Data Steering Group, working on utilising the full potential of the vast amount of health care data for regulatory decision making.
In her role as Team-leader international HTA (iHTA) at NoMA, she has been heavily involved in EUnetHTA JA3 and its successor, EUnetHTA 21. Her particular focus is on parallel EMA-HTA scientific advices, now in the role as Vice-Chair of the JSC-CSCQ.
She is furthermore involved in several academic and PPP projects as member of Scientific Advisory boards on subjects such as RWD, Patient reported outcomes, rare diseases, paediatric drug development and decentralized trials and digital tools.
10:30 - 11:00
Morning Break
11:00 - 13:00
Session 2: Regulatory Topics
Sujit Khune, Novo Nordisk A/S
Vandsalen
11:00 - 11:30
PMDA Presentation
Dr. Yuki Ando, PMDA
11:30 - 12:00
FDA’s Study Data Policy Framework and How CDISC Properties Are Evaluated for Inclusion
Helena Sviglin, FDA-CDER
12:00 - 12:30
Data Submission and Evidence Generation in Europe - an EMA Update
Eftychia-Eirini Psarelli, EMA
12:30 - 13:00
Regulatory Panel Session
- Dr. Yuki Ando, PMDA
- Helena Sviglin, FDA-CDER
- Eftychia-Eirini Psarelli, EMA
- Dr. Lisa Lin, FDA-CBER
- Dr. Anja Schiel, NoMA
- Claus Bang Pedersen, DKMA
13:00 - 14:00
Lunch
Poster Session
14:00 - 15:30
Session 3: Track A- CDISC Foundational
Éanna Kiely, Alexion
Vandsalen
14:00 - 14:30
Special Handlings Required for Questionnaires, Ratings, and Scales
Jintao Shi, Boehringer Ingelheim
14:30 - 15:00
Proposal for New ADaM Paired Variables: PARQUAL/PARTYPE
Monika Kawohl, mainanalytics GmbH; Elizabeth Dennis, EMB Statistical Solutions, LLC; Paul Slagle, IQVIA
15:00 - 15:30
Everything you Want to Know About CTUG, CT Relationships and Other Controlled Terminology topics
Ward Puttemans, SolCur; Erin Muhlbradt, NCI-EVS; Anna Pron-Zwick, AstraZeneca
14:00 - 15:30
Session 3: Track B- Biomedical Concepts
Simon Lundberg, AstraZeneca
Ballonsalen + Blomstersalen
14:00 - 14:30
The Development of CDISC Biomedical Concepts: Update and Next Steps
Jon Neville, Bess LeRoy CDISC
14:30 - 15:00
Creating CORE Rules from Biomedical Concepts
Johannes Ulander, data4knowledge ApS
15:00 - 15:30
Extending Biomedical Concepts to Analysis
Kirsten Langendorf, data4knowledge ApS
14:00 - 15:30
Session 3: Track C- Governance
Silvia Faini, Cytel
Arkaden 8
14:00 - 14:30
To EC or not to EC, that is the Question
Caroline Francis, AstraZeneca
14:30 - 15:00
The Joy (and Pain) of Implementing a Higher SDTM and SDTM IG Version ‐ A Sponsor Story
Kathleen Hectors, Janssen
15:00 - 15:30
SDTM and define.xml Automation Made Easy
Vicky Poulsen, Hanne van Kints Novo Nordisk A/S
15:30 - 16:00
Afternoon Break
16:00 - 18:00
Session 4: Track A- Real World Data
Stijn Rogiers, argenX
Vandsalen
16:00 - 16:30
Leveraging on Real World Evidence (RWE) to Address Pitfalls in the Design and Conduct of Clinical Trials in Africa: Strategies for Optimizing Patient Recruitment and Retention.
Obiageli Onwusaka, Kena George, ClinFocus Inc
16:30 - 17:00
Heterogeneity in Data Sources: How to Deal with it?
Thierry Escudier, Manuel Neukum, EvidentIQ
17:00 - 17:30
Creation of SDTM Datasets for a Real World Study Using Electronic Medical Records
Norman Stein, John McCrae, NorthWest EHealth
17:30 - 18:00
Panel Discussion
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Dr. Anja Schiel, Team Leader, International HTA (iHTA), Norwegian Medicines Agency (NoMA)
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Dr. Juan Jose Abellan, Statistics Senior Specialist, Data Analytics and Methods Task Force, European Medicines Agency (EMA)
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Rhonda Facile, VP, Partnerships and Development, CDISC
16:00 - 18:00
Session 4: Track B- Optimization Use Cases
Johannes Ulander, data4knowledge
Ballonsalen + Blomstersalen
16:00 - 16:30
Can We Do It Better? Real-Time Validation of SDTM Mapping Is Superior to Double Programming
Daniel Rolo, Bioforum
16:30 - 17:00
All you Wanted to Know About Blood Pressure but Were Afraid to ask?
Nicolas De Saint Jorre, Novo Nordisk; Marius Conjeaud, Neo4j
17:00 - 17:30
Displaying the ODM‐XML as a CRF Rendition Using a Style Sheet
Jørgen Iversen, LEO Pharma A/S
17:30 - 18:00
A Language‐Orientated Approach to CDISC Metadata‐Driven Automation
Stuart Malcolm, Veramed
16:00 - 18:00
Session 4: Track C- Secondary Use of CDISC
Dr. Jozef Aerts, XML4Pharma
Arkaden 8
16:00 - 16:30
Clinical Data Reuse: Opportunities and Challenges
Siddhant Prabhu, Parag Limaye, Ateeq Rehman, Deloitte
16:30 - 17:00
Automatic Defining ADaM for new Clinical Studies Using Machine Learning
Thomas Rye Olsen, Sune Darkner, Henning P. Föh, Rasmus Stenholt, University of Copenhagen, Department of Computer Science
17:00 - 17:30
CDISC Paediatric User Guide: a Successful Academic Collaboration to Improve Paediatric Data Standards
Rebecca Leary, Newcastle University; and John Owen, CDISC
17:30 - 18:00
Challenges and Opportunities for CDISC at the Intersection of Observational and Intervention Research: the ECRAID‐Base Experience with CDISC Implementation.
Ankur Krishnan, Lauren Maxwell, Steve Canham, Frank Leus, Lisanne Vincent, Ellen van Deuren, Roxanne Schaaks, Heidelberg Institute of Global Health
19:00 - 21:00
Evening Networking Event
9:00 - 10:30
Session 5: Track A- Analysis Results Standard
Angelo Tinazzi, Cytel
Vandsalen
9:00 - 9:30
CDISC Analysis Results Logical Model: Background and Overview
Bhavin Busa, Richard Marshall, CDISC
9:30 - 10:00
Coming together ‐ a Journey in the Harmonisation and Modernisation of Clinical Analysis Standards
Warwick Benger, Edwin van Stein, Saqwindar Singh, GlaxoSmithKline
10:00 - 10:30
Analysis Results Standards Guidelines and Implementation Using R Shiny
Smriti Anand, Pfizer; Jayashree Vedanayagam, Princeps Technologies Inc.
9:00 - 10:30
Session 5: Track B- Core Rules Development
Nick De Donder, Business & Decision Life Sciences
Ballonsalen + Blomstersalen
9:00 - 9:30
CDISC Conformance Rules and the CORE Engine: Progress and Roadmap
Peter Van Reusel, CDISC
9:30 - 10:00
Challenges of Creating CORE Rules
Amy Palmer, CDISC
10:00 - 10:30
Developing and Implementing CDISC CORE: a Data Manager's Testimonial
Els Janssens, SGS Health Science
9:00 - 10:30
Session 5: Track C- Governance, Part II
Silvia Faini, Cytel
Arkaden 8
9:00 - 9:30
Automate Harmonization of Study Metadata for Integrated define.xml
Nynne Louise Berthou Storm and Matthew Phelps, Novo Nordisk A/S
9:30 - 10:00
Standardisation in a Fast Growing Environment; MDR, EDC and Other Abbreviations
Louella Schoemacher, OCS Life Sciences; Jasmine Kestemont, Innovion
10:00 - 10:30
E2E clinical Development Standards - Taking us Beyond the Silos
Graham Downing, UCB BioSciences GmbH; Janneke van Blijswijk, ZS Associates
10:30 - 11:00
Morning Break
11:00 - 13:00
Session 6: Track A- Updates Towards Regulatory
Eftychia-Eirini Psarelli, EMA
Vandsalen
11:00 - 11:30
International Council on Harmonization (ICH) Progress Towards and Internationally Harmonized Clinical Electronic Structured Harmonized Protocol (CESharP)
Panagiotis Telonis, EMA; Jimita Parekh, Medable Inc.
11:30 - 12:00
FDA‐CTP and CDISC Project to Develop Tobacco Related Standards to Achieve Efficiencies for All Stakeholders
Chris Connolly, CDISC; Chrissie Cai, FDA-CTP
12:00 - 12:30
Raising Awareness for Additional FDA Data Standards Submission Recommendations
Angelo Tinazzi, Cytel
12:30 - 13:00
Adapting and Evolving with OVRR Requirements
Sarah McLaughlin and Jenn Mastri, MSD
11:00 - 13:00
Session 6: Track B- CORE Implementation
Peter Van Reusel, CDISC CSO
Ballonsalen + Blomstersalen
11:00 - 11:20
How to Extend and Run CORE
Sam Hume, CDISC
11:20 - 11:40
Tales from the Journey of a CORE Developer
Jozef Aerts, XML4Pharma
11:40 - 12:00
How we Achieved Real Time Validation by Integrating CORE into our Django (Python) Clinical Trial Platform
Madeleine De Forest‐Brown, Amiel Kollek, Lindus Health
12:00 - 12:20
How the new CDISC Open Rules Engine (CORE) can Improve the Speed and Quality of Dataset Deliverables in Clinical Trials
Kevin Burges and James Conway, Formedix
12:20 - 12:40
Leveraging CORE for Real Time Validation – No More Endless Iterations
Eyal Wultz, Bioforum
12:40 - 13:00
Panel Discussion
- Mark Wheeldon, Formedix
- Sam Hume, CDISC
- Eyal Wultz, Bioforum
- Jozef Aerts, XML4Pharma
- Madeline De Forest-Brown, Lindus Health
11:00 - 13:00
Session 6: Track C- Submission Experience
Simon Lundberg, AstraZeneca
Arkaden 8
11:00 - 11:30
Balancing Quality and Efficiency - a Novo Nordisk Submission Example
Adrian Czaban, Novo Nordisk A/S
11:30 - 12:00
Ensuring That a Define-XML is Submission Ready
Caro Sluijter, OCS Life Sciences
12:00 - 12:30
The Journey of a 100 Million Records Submission
Sandeep Muttanna, Vicky Poulson, Novo Nordisk A/S
13:00 - 14:00
Lunch
Poster Session
14:00 - 16:00
Session 7: Track A- Regulatory Topics, Part II
Eftychia-Eirini Psarelli, EMA
Vandsalen
14:00 - 14:45
PDUFAVII Updates: Data and Statistical Considerations when Submitting Analysis Data for DHT-Derived Endpoints
Dr. Matilde Kam, Division Director, Division of Analytics and Informatics (DAI), Office of Biostatistics (OB), OTS/ CDER, US Food and Drug Administration (FDA)
14:45 - 15:30
Advancing Premarket Safety Analytics
Dr. Y. Veronica Pei, MD, MPH, MEd; Lieutenant Commander, U.S. Public Health Service; Associate Director of Biomedical Informatics, Office of New Drugs (OND), CDER, US Food and Drug Administration (FDA)
14:00 - 16:00
Session 7: Track B- Digital Data Flow
Stijn Rogiers, argenX
Ballonsalen + Blomstersalen
14:00 - 14:30
CDISCs Activities on DDF, Benefits for the Community and Looking Ahead
Dave Iberson-Hurst, CDISC
14:30 - 14:50
Protocol Optimization with DDF
Siddarth Shah, ZS Associates
14:50 - 15:10
Using DDF to Drive Clinical Data Automation
Suman Kumar, Deloitte
15:10 - 15:30
Automating the Digital Data Flow with a Standards Foundation
Jason Konn, eClinical Solutions
15:30 - 16:00
Panel Discussion
- Dave Iberson Hurst, CDISC
- Siddarth Shah, ZS
- Suman Kumar, Deloitte
- Jason Konn, eClinical Solutions
- Mikkel Traun, Novo-Nordisk
14:00 - 15:30
Session 7: Track C- CDISC Foundational, Part II
Éanna Kiely, Alexion
Arkaden 8
14:00 - 14:30
Infant Safety Data (Associated Persons data) Collection in HIV Study
Kai Zhao, MSD
14:30 - 15:00
DHT Data Standard Subteam: A Path to Data Standardization of DHTs
Zahra Karimaddini, Roche
15:00 - 15:30
Lessons Learned with the SENDIG-DART FDA Fit-For-Use Pilot
Gitte Frausing, Data Standards Decisions Aps
16:00 - 16:15
Short Break
16:15 - 16:45
Session 8: Closing Plenary
Sujit Khune, Novo Nordisk A/S; CDISC E3C Co-Chair
Vandsalen
16:15 - 16:35
TMF Presentation
Karen Roy and Paul Fenton; TMF Reference Model
16:35 - 16:45
Closing Remarks
Sujit Khune, Novo Nordisk A/S; CDISC E3C Co-Chair