System/Data Visuals

eCTD 3.2.2 vs. 4.0, Reference: https://www.ijdra.com/index.php/journal/article/view/788

"Use a picture. It's worth a thousand words." 1911, Arthur Brisbane
Elucidating Diagrams/Visuals for Programs/Initiatives, Systems/Data, with reference links provided below:

• eCTD 3.2.2 vs. 4.0 (A table not a visual per se!)

• ICH IDMP

• ICH IDMP, Overview of ISO data elements

• EMA Network Portfolio roadmap

• PQ/CMC FHIR resources

• PQ/CMC and IDMP High-level mapping

• Digital Data Flow (DDF), Unified Study Definitions Model (USDM), ICH M11 Timeline

• ICH M11 opportunity

• ICH M4Q(R2) to Structured Product Quality Submission (SPQS)(M16)

• ICH M4Q(R1) vs. ICH M4Q(R2)

• ISPE Pharma 4.0 ™ Operating Model (Another table, not a visual per se!)

• Pistoia Alliance IDMP-ontology

• Major initiatives overlap

ICH IDMP, Reference: https://isotc215-wg6.team/wp-content/uploads/2018/07/IDMP-flyer_final_light.pdf

IDMP: Overview of ISO IDMP data elements - for illustration purposes only, Reference: https://www.ema.europa.eu/system/files/documents/other/wc500217406_en.pdf

EMA Network Portfolio roadmap, Reference: https://www.ema.europa.eu/en/documents/other/network-portfolio-roadmap_en.pdf

PQ/CMC FHIR resources, Reference: https://hl7.org/fhir/us/pq-cmc-fda/STU2/

PQ/CMC and IDMP High-level Mapping, Reference: https://www.fda.gov/industry/pharmaceutical-quality-chemistry-manufacturing-controls-pqcmc/pqcmc-and-idmp

Digital Data Flow (DDF), Unified Study Definitions Model (USDM), ICH M11 Timeline, Reference: https://www.cdisc.org/sites/default/files/2025-05/7DE%20Digital%20Data%20Flow%20ICH%20M11%20Current%20State%20and%20Aligning%20TMF%20Standards%20Development.pdf

ICH M11 Opportunity, Reference: https://www.cdisc.org/sites/default/files/2024-10/Interchange%20-%20October%20final.pdf

ICH M4Q(R2) to Structured Product Quality Submission (SPQS)(M16), Reference: https://database.ich.org/sites/default/files/M4Q%28R2%29_Step%202_Slides%20to%20Accompany%20Consultation_2025_0624_SEC.pdf

ICH M4Q(R1) vs. ICH M4Q(R2), Reference: https://database.ich.org/sites/default/files/M4Q%28R2%29_Step%202_Slides%20to%20Accompany%20Consultation_2025_0624_SEC.pdf

ISPE Pharma 4.0 ™ Operating Model, Reference: https://ispe.org/initiatives/pharma-4.0

Pistoia Alliance IDMP-ontology, Reference: https://marketing.pistoiaalliance.org/hubfs/2023-07%20IDMP%20Ontology%20Pitch%20Deck%20%281%29.pdf

From Pharmaceutical Engineering, Major initiatives overlap, Reference: https://ispe.org/pharmaceutical-engineering/january-february-2026/cohesive-vision-single-global-cmc-dossier