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PhUSE Metadata Repositories

B2ap3 Large Phuse


Metadata Repositories – Promises and Realities


The Pharmaceutical industry recognises the value of metadata but has been slow to develop Metadata Repositories (MDRs). The technology has taken time to develop. Fortunately, we now have better tools to automate and manage metadata. Metadata that has historically been saved in excel spreadsheets can now be moved into metadata repository applications. As more MDRs are adopted, the usefulness of metadata is becoming more apparent. This SDE will focus on learning from those that have or are about to implement MDRs.


AstraZeneca – MedImmune,
Gaithersburg, MD


8.30 - 9.00 Presentation Speaker
9.00 - 9.15 Welcome Keynote Speech Frank Senk &
Thejo Annareddy, AstraZeneca &
Alex Batkhan, MedImmuneNevine Zariffa, AstraZeneca VP Biostatistics
9.15 - 9.55 Metadata-driven, Standards-based Clinical Analysis and Reporting Environment Alex Hromcenco &
James Miller, AstraZeneca
9.55 - 10.30 Metadata-driven Analysis – How Users Can Benefit from Metadata Peter Schaefer,
Validated Cloud Applications
10.30 - 10.45 Morning Break  
10.45 - 11.15 How to Find the Best MDR Solution for Your Organisation Kevin Lee,
Clindata Insight
11.15 - 11.45 The Chicken and the Egg Dilemma: Why Metadata Solutions have Struggled Chris Decker &
Scott Bahlavooni,
11.45 - 12.00 PhUSE Future Forum Update Chris Hurley,
PhUSE US Events Director
12.00 - 1.00 Lunch  
1.00 - 1.30 Automating CDISC Deliverables through Processing Metadata Paul Slagle &
Eric Larson,
inVentiv Health
1.30 - 2.00 Moving from Data Collection to Data Visualisation Analytics: Leveraging CDISC SDTM Standards to Support Data Marts Steve Kirby &
Terek Peterson,
2.00 - 2.30 CDER, Regulatory Science Informatics and Metadata: What We've Learnt Salvatore Pepe,
2.30 - 2.45 Afternoon Break  
2.45 - 3.15 Implementing End-to-End Data Standards from a Metadata and Technology Perspective Michael Goedde,
3.15 - 3.45 CDISC Share: The Road Ahead Sam Hume,
3.45 - 4.30          Panel Discussion & Closing Remarks All Speakers

Catering and refreshments will be provided throughout the day.

SDE Chairs:

If you have any questions, or require any information, please contact the SDE Co-Chair.

Frank Senk, AstraZeneca

Thejo Annareddy, AstraZeneca

//">Alex Batkhan, MedImmune

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