Phlexglobal IDMP Headstart Program

Efficient, Affordable IDMP Preparation Using Your Own Data

What is IDMP Headstart?

With IDMP (Identification of Medicinal Products) compliance deadlines approaching rapidly, IDMP Headstart is designed to let you begin working today in the IDMP structured data format, using your own product data. This turnkey solution includes Phlexglobal’s PhlexIDMP software, one of the only solutions fully aligned today with the current EU Implementation Guides (v2.x).

The result? By working with you own product information in PhlexIDMP, you can pinpoint where the required data resides, identify any gaps, and accurately scope the work required – accelerating IDMP-readiness and avoiding potential registration issues.

 

 

 

 

 

 

PhlexIDMP Headstart

Key Benefits of the Phlexglobal

IDMP Headstart Program

TMF Software

Start working with your data in IDMP format today

TMF Process Optimization-01

Easily pinpoint where the data resides and scope work required to make it IDMP-ready

Reports-01

Help ensure compliance and avoid potential registration problems by identifying data gaps early

Database

PhlexIDMP software stays current with ongoing updates to the EU IDMP implementation guides

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Making the shift to IDMP structured data now will pay dividends later:

  • Improve organizational efficiency
  • Increase data accuracy and consistency
  • Gain a solid foundation for related initiatives such as DADI, CTIS, ePI and more
Infographic -  Phlexglobal IDMP Headstart Program

Want more details?

Download the Headstart Infographic

Efficiently and affordably start your IDMP preparations using your own data!

PhlexIDMP Headstart

Accelerate Your IDMP Preparation with

3 Simple Steps

  1. Contact Phlexglobal and sign up! (No Long-Term Commitment Required)

  2. Take the Online Training Course (Provides Everything You Need to Work with PhlexIDMP software)
  3. Start Getting Hands-on Experience with IDMP and Its Impact on your Regulatory Processes

 

PhlexIDMP Screen

 

 

Interested? Complete this form and we will be in touch.

Get Ready now for Upcoming IDMP Compliance Deadlines

The two-year countdown to IDMP compliance began with the release of the EU IDMP Implementation Guide v2.0 in February 2021. For all products authorized via the EU's Centralized Procedure, you will need to validate and enrich the xEVMPD data in the SPOR PMS database to ensure it is IDMP-ready for any submissions. Plus, it's expected that by 2023 all new Centralized Procedure submissions must be in the IDMP structured data format and submitted by FHIR message in the eCTD.

IDMP Time Line

 

IDMP Checklist on Table

Want to Learn More about IDMP?

Download our whitepaper "10 Key Steps to Help you Prepare for IDMP Compliance" which covers topics such as 

  • Understanding IDMP requirements
  • Analyzing organizational impact
  • Determining data governance
  • Analyzing data sources
  • Preparing data
  • Defining the data approval and submission process

Read the whitepaper

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