Upcoming webinars and workshops
At this moment we don’t have any upcoming webinars.
Previous webinars and workshops
Webinar CTIS: ready or not, here it comes
The EU Clinical Trial Regulation (CTR) will introduce a new Clinical Trial Information System (CTIS) that provides a collaborative platform for Sponsors and Regulators to manage trials across the EU. It promotes patient safety, supporting cross border trials and increased transparency. Sponsors will be required to undertake organizational transformation to ensure compliance with CTR.
Date: 20 September 2021
Host(s): Sebastian Payne & Duncan van Rijsbergen
More informationWebinar CTIS: ready or not, here it comes
20 September 2021
Sebastian Payne & Duncan van Rijsbergen
Live update ISO IDMP EU Implementation Guide v2.1
On Wednesday, 30 June 2021 EMA has released version 2.1 of the ISO IDMP EU Implementation Guide. This release of this version is a steppingstone towards the implementation of ISO IDMP in Europe and initially for the Centralised Procedure.
Date: 5 July 2021
Host(s): Remco Munnik
More informationLive update ISO IDMP EU Implementation Guide v2.1
5 July 2021
Remco Munnik
Webinar The IDMP roadmap: current EMA needs and longer term telematics
On May 26th, Frits Stulp joined Amplexor’s Life Sciences’ Be The Expert 2021 to talk about how you make sure your IDMP approach for the first EMA step is compatible with upcoming releases, the longer term telematics implementation and with your own master data strategy.
Date: 26 May 2021
Host(s): Frits Stulp
More informationWebinar The IDMP roadmap: current EMA needs and longer term telematics
26 May 2021
Frits Stulp
Webinar ISO IDMP EU Implementation Guide V2.0
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). We are extremely proud with the support that our team provided in the draft and review of the EU IG to bring ISO IDMP closer towards reality. We strongly believe in the value of ISO IDMP and look forward in taking the next steps with regards to implementation in Europe.
Date: 1 March 2021
Host(s): Remco Munnik
More informationWebinar ISO IDMP EU Implementation Guide V2.0
1 March 2021
Remco Munnik
Webinar Elevating your RIM Program
Lessons from World Class RIM Benchmark Top Performers
Lessons from World Class RIM Benchmark Top Performers. 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 of 66 companies during this webinar. 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
Host(s): Remco Munnik and Steve Gens
More informationWebinar Elevating your RIM Program
9 July 2020
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
Host(s): Frits Stulp
More informationWebinar IDMP Implementation in Europe: Time to Act
28 May 2020
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
Host(s): Frits Stulp and Camiel Hoogendoorn
More informationWebinar Substance Management
25 May 2020
Frits Stulp and Camiel Hoogendoorn
Webinar EU 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
Host(s): Remco Munnik
More informationWebinar EU Implementation Guide
30 March 2020
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
Host(s): Frits Stulp, Sara Berdajs and Lunyan Zhu
More informationWebinar Structured Content Authoring
16 January 2018
Frits Stulp, Sara Berdajs and Lunyan Zhu
Webinar ERP-RIM Integration
In this third webinar of our webinar series, we looked into the integration of ERP with RIMs and how that can help improve the supply chain oversight.
Date: 7 December 2017
Host(s): Frits Stulp, Duncan van Rijsbergen and Lunyan Zhu
More informationWebinar ERP-RIM Integration
7 December 2017
Frits Stulp, Duncan van Rijsbergen and Lunyan Zhu
Webinar RIM Business Implementation
In this webinar we introduced ways to optimize the use of your RIM system.
Date: 17 October 2017
Host(s): Frits Stulp and Lunyan Zhu
More informationWebinar RIM Business Implementation
17 October 2017
Frits Stulp and Lunyan Zhu