DHC web session (in German)

Identification of medicinal products (IDMP)
with SAP Cloud App Polaris
July 12, 2024

IDMP with SAP Cloud App Polaris

Topic

The harmonisation of standards is being driven forward by the EU with great effort. One area for harmonisation is the identification of medicinal products (IDMP) on the European market.

he core idea behind the IDMP is an in-depth knowledge of the medicinal products on the market with a special focus on their composition and their pharmacovigilance. This is achieved by consolidating and centrally filing the data. For the implementation of this IDMP initiative, the EU is consolidating five ISO standards. It is mandatory that the IDMP initiative be implemented by the pharmaceutical companies concerned by the deadline. In addition to the EU, other authorities such as the FDA and local authorities also demand corresponding information.

This means that in future all MAHs (Marketing Authorisation Holders) will have to transmit considerably more structured data (IDMP or for the EU then SPOR-compatible data) to the authorities. SPOR stands for the 4 EMA databases SMS (Substance Management System), PMS (Product), OMS (Organisations) and RMS (Referentials). SMS, OMS and RMS are productive. The PMS is scheduled for completion next year. The PMS will replace the EMA database SIAMED and XEVMPD.

The SAP cloud app “Polaris” from the company Gramont can be used to support the tasks involved. Gramont Polaris is an SAP cloud application from the SAP Industry Cloud Life Sciences with integration to SAP S/4HANA and SAP ECC for the consolidation of structured and unstructured data for the preparation of electronic submission of marketing authorisation dossiers. It enables the integration, aggregation and standardisation of this data and its conversion to ISO IDMP standards, terminology and formats. The software offers a flexible architecture that helps companies meet additional requirements as they arise.

The IDMP App offers the following functions:

  • Management of product information on medicines and medical devices.
  • Regulatory content preparation, submission and marketing authorisation tracking
  • Management of structured and unstructured data
  • Management of controlled vocabularies
  • Product change planning, tracking and integration
  • Integrated data quality and consistency checks
  • A flexible framework that supports current and future data exchange procedures worldwide

It is an integrated extension of SAP ECC and S/4HANA products and is SAP’s standard way of managing this part of the business process for product data submission/registration.

The web session presents the concept and the software including an update on the IDMP roadmap of the EMA.

Date

Friday, 12. July 2024, 10:00 – 10:45 a.m. (CET) => You missed the web session? Then request the podcast now!
No time on this date? Then simply register anyway and secure your access data for the free podcast! You will receive them automatically shortly after the web session.

Target group of the web session

This webinar is aimed at specialists and managers from the pharmaceutical industry who are concerned with the optimisation of processes in the regulatory area – especially due to the increasing requirements such as IDMP.

Content of the websession

  • Introduction to IDMP
  • Presentation of the SAP Cloud IDMP App Polaris
  • Live demo of the system
  • Procedure for the introduction

Your benefits

  • Understanding of the challenges of IDMP regulations
  • Overview of the SAP Cloud IDMP App Polaris as an integrated SAP solution
  • Overview of the upcoming tasks and efforts for the IDMP implementation

TECHNICAL REQUIREMENTS

The web sessions are online seminars. To participate, all you need is a PC with an internet connection and loudspeakers. Alternatively, audio can be transmitted via telephone, while you can follow the image presentation via your browser. The web sessions are interactive, i.e. you can ask questions at any time.

PARTICIPATION AND REGISTRATION

The web session will be held in German. If you only speak English, please contact us via email for a personal online appointment (consulting@dhc-gmbh.com). We are looking forward to meeting you!

Register now: https://attendee.gotowebinar.com/register/2110168862229394528 

=> You missed the web session? Then request the podcast now!

Polaris is a registered trademark of Gramont GmbH, Pfäffikon, Switzerland; SAP and other SAP products and services mentioned as well as their respective logos are trademarks or registered trademarks of SAP SE in Germany and other countries.

DHC WEB SESSIONS

Our web sessions are provided as a free service for DHC customers and potential customers.