PRODUCTS

PLS PORTAL

ESM PORTAL OVERVIEW

Function

ESM Portal is currently being developed to support the European Medicines Agency's (EMA) recently announced guidance regarding electronic submission of information on medicines (ESM) by marketing-authorisation holders. The application is a web-based solution with a central repository that allows global pharmaceutical companies to manage the life-cycle associated ESM submissions.

Central Repository

XML content will be stored and versioned at the section level within the ESM Portal database. Associations will be created and maintained allowing for centralized updates. Updates to associated data will be automatically propagated to all mapped products, allowing for the most up-to-date information to be included with each subsequent submission.

Multiple Delivery Models

ESM Portal can be hosted internally by your organization or companies can subscribe to the hosted Software-as-a-Service (SaaS) application. The SaaS model provides immediate global access with no software to purchase or install.

Audit Trail

All modifications will be captured by user name and date. Additionally, ESM Portal captures content values before and after an update. This feature will provide the basis for ESM Portal’s audit trail functionality.

Statistics Dashboard

ESM Portal will provide a robust statistics dashboard that details how many submissions an organization has created by: date, submission type, labeling type, and product.

RELEASE DATE

Intagras is currently developing the ESM Portal application. The Beta application will be ready in Q1 of 2012. The production version is currently targeted to have an early Q2 of 2012 release.


The EMA announcement regarding ESM submissions was updated on September 1st 2011. Please click this link for more information on the initiative.

FEATURE LIST

Establishment Repository

  • On Demand Validation
  • Association of Data to Products
  • Dynamic Updates for Associated Data
  • Full ESM validation
  • Single location update
  • Multiple product association
  • Audit Trail

Editor

  • Version Control
  • Audit Trail
  • MS Word and PDF creation

Product Formulation Definition

  • Active Ingredients
  • Inactive Ingredients
  • Packaging
  • Administration
  • ...and more

ESM Import

  • XML validation