DHC web Session series (in German)

Implementation of IDMP with SAP (Part1)
Thursday, 21 November 2024, 3:00 - 3:45 p.m.

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: Thursday, 14 November 2024, 15:00 – 15:45
Webinar series, part 2: Thursday, 21 November 2024, 15:00 – 15:45
No time on one or both dates?Register anyway and get access to the free podcast!You will receive it automatically shortly after the webinar.

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.
Register now for free at
https://attendee.gotowebinar.com/register/2145899694586585431

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.

WEBINARs AND EVENTS

14. November
DHC web session (in German)

Webinar series: Implementing IDMP with SAP (Part 1)

Presentation of the EMA’s IDMP initiative and the SAP cloud application Gramont Polaris for regulatory dossiers.

more
15. November
DHC web session (in German)

GxP-compliant digitisation of laboratories

Discover how digital transformation is increasing the level of automation and optimising your laboratory processes in a GxP-compliant way.

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20. November
DSAG event

Focus Day “SAP Digital Manufacturing” – DSAG AK Life Sciences Processes

Look forward to exciting talks, a visit to the new S.Factory and stimulating discussions.

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21. November
DHC web session (in German)

Webinar series: Implementing IDMP with SAP (Part 2)

Presentation of Gramont Polaris, the SAP cloud application for the preparation and electronic submission of marketing authorisation dossiers.

more
21. November
DHC & LSA Web session (in German)

SAP S/4HANA Transformation and Validation with VITAL Process Model for Life Sciences

Learn everything about phases for the system transformation (system conversion) of an SAP ECC to S/4HANA with integrated validation.

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29. November
DHC & LSA Web session (in German)

SAP S/4HANA implementation and validation with the ‘VITAL’ process model for life sciences

Find out what benefits the LSA approach offers you for the optimal, validated deployment of S/4HANA.

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13. December
DHC web session (in German)

GxP-compliant validation of AI applications

We explain how the V-model for validation needs to be adapted to address AI-specific issues.

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25. January
DHC web session (in German)

Valid SAP ERP operation with DHC Managed Validation Services – a case study

Find out what customised Managed Validation Services can include and what benefits they offer.

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DHC WEB SESSIONS

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