| PharmaSUG CN |
2026 |
Modernizing the Vaccine TAUG: An End-to-End, Output-Driven Framework for Reactogenicity, Immunogenicity, Efficacy, and Reviewer-Ready Submissions |
Lin Chen,
Jialiang Liu |
source |
18 |
| PharmaSUG CN |
2026 |
When Data Capture Becomes Data: How ePRO and e-Diary Systems Reshape CDISC Standards, Statistical Programming, and Endpoint Analysis in Vaccine Studies |
Jialiang Liu,
Lin Chen |
source |
16 |
| MWSUG |
2025 |
Prompt, Program, Submit: Generative AI for Faster SDTM, ADaM, and TLFs |
Matthew J. Becker,
Pankaj Attri |
source |
7 |
| WUSS |
2025 |
Prompt, Program, Submit: Generative AI for Faster SDTM, ADaM, and TLFs |
Matthew J. Becker |
source |
7 |
| PHUSE US |
2025 |
Management of Regulatory Submissions Using eCTD Sequences and Life Cycle Operators: Lessons from Real-Time Oncology Review (RTOR) and Regular Submissions |
Madhusudhan Reddy Papasani,
Elisabeth Pyle,
Mary N. Varughese |
source
presentation source |
8 |
| PharmaSUG |
2023 |
Consistency Checks Automation across Regulatory Submission Documents in the eCTD M5 folder |
Majdoub Haloui,
Loganathan Ramasamy,
Hemu Shere |
source |
8 |
| PHUSE US |
2023 |
Shiny for Submissions [presentation] |
Philip Bowsher,
Eric Nantz |
source |
22 |
| PHUSE EU |
2022 |
The Integration Dilemma |
Angelo Tinazzi |
source
video
presentation source |
15 |
| PHUSE EU |
2021 |
F3: Fitness, FAIR & Filing [presentation] |
Bhupendra Mistry,
Nigel Montgomery |
source
video |
19 |
| PHUSE EU |
2021 |
How to Be Traceable in ADaM |
Angelo Tinazzi |
source
video
presentation source |
9 |
| PHUSE EU |
2021 |
New Starters Session: The Secret Sauce to Start in Our Industry [presentation] |
Amritpal Singh,
Lucie Bowden |
source |
10 |
| PHUSE US |
2021 |
China Center for Drug Evaluation, NMPA Electronic Study Data Submission Requirements [presentation] |
Majdoub Haloui,
Yanhong Li |
source
video |
16 |
| PHUSE US |
2021 |
Pinnacle 21: Improving the Data Fitness Score for eSubmission |
Renu Motwani |
source
video
presentation source |
9 |
| PharmaSUG |
2021 |
SEND for CBER |
Lisa Lin |
source |
26 |
| PHUSE EU |
2020 |
Please Take Care of Your Metadata |
Angelo Tinazzi |
source
video
poster source |
5 |
| PHUSE US |
2020 |
Handling Duplicate Records in SDTM for Effective Resolution and Explanation in Data Submission |
Varun Debbeti |
source
presentation source |
8 |
| PharmaSUG |
2019 |
The Need for Therapeutic Area User Guide Implementation |
Michael Beers |
source |
8 |
| PHUSE US |
2019 |
DR3 - A Tool to Create Define-XML (SDTM/ADaM with ARM) [presentation] |
Eric Weising |
source |
7 |
| PHUSE US |
2019 |
Ensuring Consistent and Supported Standards Across Data and Metadata in a Large Regulatory Filing is Tricky Business |
Lisa Kaye Brooks |
source
presentation source |
10 |
| PHUSE US |
2019 |
High-quality Study Data Standards for Submission |
Majdoub Haloui,
Ellen L. Asam |
source
presentation source |
9 |
| PHUSE US |
2019 |
The Need for Therapeutic Area User Guide Implementation |
Michael Beers |
source
presentation source |
7 |
| PHUSE EU |
2018 |
How to Easily Generate Define.pdf from Define-XML - Submission Request |
Ralf Goetzelmann,
Endri Elnadav |
source
presentation source |
5 |
| PHUSE EU |
2018 |
The "CDISC Stupidario" (the CDISC Nonsense) |
Angelo Pinazzi |
source
poster source |
11 |
| PHUSE US |
2018 |
ADaM Intermediate Dataset: How to Improve Your Analysis Traceability |
Angelo Tinazzi,
Ashish Aggarwal |
source
presentation source |
12 |
| PHUSE EU |
2017 |
An FDA Submission Experience Using the CDISC Standards |
Angelo Tinazzi,
Cédric Marchand |
source
presentation source |
15 |
| PharmaSUG CN |
2017 |
Assigning VISITNUM and EPOCH [presentation] |
Na Duan,
Ru He |
|
32 |
| PHUSE EU |
2016 |
What is high quality study metadata? |
Sergiy Sirichenko,
Max Kanevsky |
source
presentation source |
9 |
| WUSS |
2016 |
Are you ready for Dec 17th, 2016 - CDISC compliant data submission? |
Kevin Lee |
source |
6 |
| PharmaSUG |
2016 |
Importance of Niche Provider for Successful NDA Submission: Rescue Case Study |
Aparna Poona,
Bhavin Busa,
Tim Southwick |
source |
9 |
| PharmaSUG |
2016 |
What is high quality study metadata? |
Sergiy Sirichenko,
Max Kanevsky |
source |
9 |
| PHUSE EU |
2014 |
Looking for SDTM Migration Specialist |
Angelo Tinazzi |
source
presentation source |
12 |
| PHUSE EU |
2014 |
Traceability: Plan Ahead for Future Needs |
Sandra Minjoe |
source
presentation source |
8 |
| PHUSE EU |
2013 |
Evolving Regulatory Guidance on the Submission of Standardised Data [presentation] |
James R. Johnson |
source |
25 |
| PharmaSUG |
2012 |
An Innovative ADaM Programming Tool for FDA Submission |
Xiangchen (Bob) Cui,
Min Chen,
Tathabbai Pakalapati |
source |
25 |
| PharmaSUG |
2011 |
A Cost-Effective SDTM Conversion for NDA Electronic Submission |
Xiangchen (Bob) Cui,
Scott E. Moseley,
Min Chen |
source |
12 |
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