IDMP Readiness

Meet IDMP requirements with software and services from Phlexglobal. 

IDMP Ramp-Up Program

Due to its complexity, IDMP (Identification of Medicinal Products) readiness is one of the greatest concerns among regulatory affairs. Phlexglobal has designed an IDMP Ramp-Up Program to facilitate a smooth transition from xEVMPD to IDMP.

 

 

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Step 01

Data Source Analysis

 1 - 3 Weeks

  1. IDMP Data Source Analysis Tool
  2. Delta Data Workshop (xEVMPD versus IDMP)
  3. Analyse Data Sources
    • xEVMPD
    • Pharmaceutical Product
    • Manufacturing
    • Packaged Product                   

RESULT:

Data Analysis Summary

Step 02

Data Collection & Entry

 1 - 2 Weeks

  1. IDMP Test System Access
  2. Data Assembly
    • GiNAS, UCUM, EDQM
    • External: CMO, CRO, API etc.
    • Internal Submission Import
    • Internal Legacy Import (Excel)
    • Internal Paper Based Data
    • Internal Manual Data Entry

RESULT:

min. 3 products IDMP ready

Step 03

IDMP Submission Preparation

Unlimited 

  1. Data System Rollout
    • Configuration
    • API connections
    • Validation
    • User Training
  2. CC'd Data Collection & Entry
  3. Regulatory Reporting                                                                                                

RESULT:

IDMP Submission

More Details...

The gradual ramp up program facilitates a smooth migration from xEVMPD to IDMP. Each step contains a specific scope, time line, deliverable and cost structure.

Step 1 starts with a review of the complete data requirements as per the ISO IDMP guidelines. A data checklist with pre-categorized data types will be provided. The checklist will be the base for the xEVMPD versus ISO IDMP data gap analysis. Web meetings are being used to effectively agree on interpretations. Remote support will be provided during the entire program.

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Advantages of the Ramp-up Program

  • Secure transition from xEVMPD to IDMP
  • Personalized to your corporate needs
  • Supported by a smart IDMP software
  • Data pull from MedDRA, GInAS, UCUM, EDQM
  • Guaranteed 100% IDMP compliance
  • Cost effective

Step 2 and Step 3 are building on the results of step 1. Both steps are being individualized depending on the corporate needs of your organization. Step 1 will result in IDMP reports with correct IDMP data. Step 2 will provide a complete electronically created compliant IDMP submission, ready to be submitted.

The entire program is supported and accompanied with the use of Phlexglobal's IDMP software. Results created and date entered can be exported at any point in time.

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IDMP Readiness Graph

 

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