From Fragmentation to Unification: The Netflix Moment for Regulatory Exchange

The current state of regulatory exchange is like driving to Blockbuster to rent a VHS. It’s fragmented, slow, and costly. Industry and regulators alike are forced to navigate dozens   of different formats, channels, and proprietary systems for different product lines and procedures.

APIX is the Netflix model for regulatory exchange. Built on HL7 FHIR, it provides one universal standard and one platform for all products and procedures.

• • For Regulators: A single, unified pipe to receive, validate, and manage interactions across all domains—drastically reducing IT maintenance costs and manual processing overhead.

• • For Industry: A single API to submit, track, and manage every regulatory procedure globally.

     Join us for the first public technical demonstration of the APIX standard.

     Link to the Project Implementation Guide (IG):      https://build.fhir.org/ig/HL7/APIX—API-Exchange-for-Medicinal-Products/branches/main/en/index.html

• • Date: 10th June 2026

• • Time: 11.00am EST

• • Format: Virtual

• • Register at https://wkf.ms/4ddbkVm
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     In 90 minutes, you will see:

• • Universal Submissions: Watch a filing go straight to a regulator via the universal API.

• • Instant Tracking: See “FedEx-style” live status updates across an entire portfolio.

• • Automated Q&A: Witness structured regulator questions and structured applicant responses routing machine-to-machine.
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      Agenda

1. 1. 15 min – Introduction by Rita Algorri (Amgen) and Craig Anderson (J&J)

1. 1. 60 min – Technical demonstrations
      
      1. 1. 20 min – Rita Algorri (Amgen)
      1. 1. 20 min – Kåre Hyttel (NNIT)
      1. 1. 20 min – Omar Serang (DNAnexus)

1. 1. 15 min – Q&A + Next steps 

      For: Regulators & Health Authorities · RA Leaders · IT & Digital Transformation · Solution Providers