Webinars

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

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

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

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

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

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

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

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

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

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

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