Webinar series: Implementing IDMP with SAP (Part 1)

The EU is making great efforts to harmonise standards. One area of alignment is the Identification of Medicines in the European Market (IDMP). The core idea behind IDMP is to improve knowledge of medicines on the market, with a particular focus on their composition and pharmacovigilance. This will be achieved by pooling and centrally storing data. To implement this IDMP initiative, the EU is consolidating five ISO standards. The IDMP initiative must be implemented by the pharmaceutical companies concerned by the deadline. In addition to the EU, other authorities such as the FDA and local authorities are also requesting this information. This means that in future all MAHs (Marketing Authorisation Holders) will have to submit significantly more structured data (IDMP or SPOR-compliant data for the EU) to the authorities. In order to prepare the submission of product information, a large amount of data has to be collected throughout the company (RA, R&D, production, QM, supply chain, etc.). To do this, companies need to have the right IT systems and processes in place. Gramont’s SAP Cloud solution Polaris can be used to support these tasks. Gramont Polaris is an SAP cloud application that integrates with SAP S/4HANA and SAP ECC to consolidate structured and unstructured data in preparation for electronic submission of regulatory dossiers. It enables the integration, aggregation and standardisation of this data, as well as its transformation into ISO IDMP standards, terminology and formats. It offers a flexible architecture to help companies meet additional requirements as they arise.

The IDMP solution provides the following functionality:

• Management of product information for medicines and medical devices
• Regulatory content preparation, submission and tracking
• Manage structured and unstructured data
• Controlled vocabulary management
• Planning, tracking and integration of product changes
• Integrated data quality and consistency checks
• A flexible framework that supports current and future global data exchange practices

It is an integrated extension to the SAP ECC and S/4HANA products and is SAP’s standard method for managing this part of the business process for submission/registration of product data.
The first part of the webinar series introduces the EMA’s IDMP programme and explains how the IDMP regulations are structured.The second part will introduce the SAP Cloud IDMP solution Polaris.

Webinar dates

Webinar series, part 1: Wednesday, September 3, 2025, 2:00 p.m. – 2:45 p.m.

Webinar series, part 2: Tuesday, September 23, 2025, 10:15 a.m. – 11:00 a.m.

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

Webinar Audience

This webinar is aimed at professionals and managers in the pharmaceutical industry who are concerned with optimising processes in the area of regulatory affairs, particularly in the context of increasing requirements such as IDMP.

Content of the webinars

Webinar 1:

• Management of product information for medicines and medical devices
• Regulatory content preparation, submission and tracking
• Manage structured and unstructured data
• Controlled vocabulary management
• Planning, tracking and integration

Webinar 2:

• Brief summary of IDMP from Webinar 1
• Introduction to SAP Cloud IDMP solution Polaris
• Live system demo
• Approach to implementing the SAP IDMP solution

Your benefit

• Understand the challenges of IDMP regulations
• Overview of the SAP Cloud IDMP solution Polaris as an integrated SAP solution
• Overview of IDMP implementation tasks and efforts

TECHNICAL REQUIREMENTS

The web sessions are online seminars. All you need to participate is a PC with an internet connection and speakers. Alternatively, the sound can be transmitted via telephone while you follow the presentation via your browser. The web sessions are interactive, so you can ask questions at any time.

ATTENDANCE AND REGISTRATION

This web session is a free service for Life Sciences Alliance customers and prospects.
IT service providers and consultants are not eligible to attend.
Attendance is limited.

=> 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 logos are trademarks or registered trademarks of SAP SE in Germany and other countries.