With the publication of the ISO IDMP EU Implementation Guide V2.0, the actual implementation clock becomes a reality. The published guidance should give sufficient instructions to all involved parties: Regulators, Industry and Vendors to prepare. As IDMP has a significant impact on the organization and V2.0 provides more insights in the to-be established processes of submission of structured data with the regulatory activities (the Target Operating Model: TOM)
Date: 1 March 2021
Time: 4 PM CET / 10 AM ET
Presenter(s): Remco Munnik
Together with our strategic partner, Gens and Associates, Inc., we will share the critical learnings to improve the performance of your RIM program from the recent 2020 World Class RIM℠ – Study. We will dive into RIM base capabilities, degree of experimentation with emerging technology, and how successfully connect RIM to the Enterprise. We will also share the latest data on the journey of Structured Data Submission requirements.
Date: 9 July 2020
Time: 4 PM CEST / 10 AM EST
Presenter(s): Remco Munnik and Steve Gens
Webinar IDMP Implementation in Europe: Time to Act
There are many reasons why life sciences companies should not delay their data-driven regulatory information management initiatives. At his session during Amplexor’s BE THE EXPERT on 28 May, Frits Stulp of Iperion Life Sciences Consultancy spelled out the accelerating urgency around data-driven transformation of regulated information processes, provided an update on the latest status of IDMP, and explored the shift towards electronic product information as one of the latest use cases that will invite change.
Date: 28 May 2020
Presenter(s): Frits Stulp
Webinar Substance Management
Substance management is about the identification of substances within pharmaceutical products and the consistent use of the same information throughout the life cycle of your products. This includes but is not limited to regulatory processes, research and manufacturing and control processes.
Date: 25 May 2020
Presenter(s): Frits Stulp and Camiel Hoogendoorn
Webinar ISO IDMP Implementation Guide
In February 2020, EMA published Iteration 1 of the EU ISO IDMP Implementation Guide. The EU IG provides detailed guidance on how ISO IDMP data fields should be interpreted, submitted and maintained within the EU regulatory framework supported by SPOR (Substances, Products, Organisations and Referentials Management Services).
Date: 30 March 2020
Presenter(s): Remco Munnik
Webinar Structured Content Authoring
In this webinar, we have illustrated Structured Content Authoring (SCA) as a use case for process improvements and data interoperability. Through practical examples, we have outlined the role SCA can play in the pharma industry. The webinar also emphasizes the key steps required for a successful implementation of SCA.
Date: 16 January 2018
Presenter(s): Frits Stulp, Sara Berdajs and Lunyan Zhu
Webinar ERP-RIM Integration
In this webinar we looked into the integration of ERP with RIMs and how that can help improve the supply chain oversight.
Date: 7 December 2017
Presenter(s): Frits Stulp, Duncan van Rijsbergen and Sara Berdajs
Webinar RIM Business Implementation
In this webinar we introduced ways to optimize the use of your RIM system.
Date: 17 October 2017
Presenter(s): Frits Stulp and Lunyan Zhu