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RIM – Is data-driven Regulatory Information Management your reality?

Many life science companies have undertaken a long journey to establish, expand, and improve their Regulatory Information Management system landscape throughout the past years.
Although much progress has been made and a well-established baseline is observed across the entire industry, there is still a journey ahead of us when it comes to the management of regulatory content. How far have companies managed to transition from content to a data-centric approach and how well are they prepared to do so in the future? What can we learn from those who have achieved this next level of maturity and which system capabilities should we consider key to supporting such a transformation?

In this webinar Steve Gens, Founder and Managing Partner of Gens & Associates will share a new perspective from the Gens & Associates 2020 World Class RIM benchmark that focuses on those companies who are much further ahead in realizing the promise of a data-driven approach. In their research, they segmented “content” and “data” related RIM capabilities and took just the top performers to understand their journey and how they are investing. Steve will provide a viewpoint to where progressive organizations will be with their RIM programs in the next 3 – 5 years, the path to high performance based on 100 + companies analysis, and a governance model for data quality sustainability.
Agnes Cwienczek, Amplexor's Head of Product Management and Consulting, will elaborate further on the shift from a content/document-focused towards a data-centric approach and the triggers facilitating the move. She will discuss the key capabilities of a data-driven solution and highlight the benefits to put data first. At the end of the presentation, Agnes will conclude with a demonstration of practical examples of how the Amplexor Life Sciences Suite is addressing the arising data-centric requirements of the industry.
Recorded Apr 7 2021 68 mins
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Presented by
Steve Gens (Gens & Associates) & Agnes Cwienczek (Amplexor)
Presentation preview: RIM – Is data-driven Regulatory Information Management your reality?

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  • How Regulatory Information Management Systems can support Life Sciences Jun 16 2021 1:00 pm UTC 59 mins
    David Gwyn, Vice President for Life Sciences, Amplexor
    Covid-19 has triggered unprecedented disruption to global life sciences and public health, exposing some gaping holes in drug companies’ product insights and regulatory responsiveness. In this webinar, David Gwyn will explore some of the lessons learnt in 2020 to assess how companies might transform their regulatory operations in 2021, improve their adaptability and become better equipped for continued uncertainty.

    He will demonstrate how pharmaceutical companies must get their global operations in order and render their regulatory information more tightly interwoven. Whatever organizations’ immediate agenda, an effective plan for 2021 in relation to RIM transformation must be put in place.
  • IDMP from two perspectives: theory and practice May 27 2021 1:00 pm UTC 59 mins
    Frits Stulp, Managing Director, Iperion Life Sciences Consultancy / Siniša Belina, Amplexor's Senior Life Sciences Consultant
    The second version of the EU IDMP Implementation Guide is expected to be published in December this year. This new release contains updates on the Medicinal Product Information data model and the process of how the product data should be submitted as part of the Target Operating Model (TOM). This publication will be the start of the 24-month period before IDMP becomes mandatory for the industry.

    In this webinar Frits Stulp, Managing Director of Iperion Life Sciences Consultancy and IDMP expert will give a general status update on IDMP. He will cover data model updates as well as the future data submission process according to the proposed TOM, including insights on how the current 3rd acknowledgement process will be addressed.

    Siniša Belina, Amplexor's Senior Life Sciences Consultant, will present the impact of the EU IDMP Implementation Guide on the AMPLEXOR Life Sciences Suite. He will demonstrate the implementation of the required IDMP data fields as part of the ProductExpert solution as well as discuss what processes need to be in place to comply with the TOM within the RIMExpert solution.
  • RIM – Is data-driven Regulatory Information Management your reality? Recorded: Apr 7 2021 68 mins
    Steve Gens (Gens & Associates) & Agnes Cwienczek (Amplexor)
    Many life science companies have undertaken a long journey to establish, expand, and improve their Regulatory Information Management system landscape throughout the past years.
    Although much progress has been made and a well-established baseline is observed across the entire industry, there is still a journey ahead of us when it comes to the management of regulatory content. How far have companies managed to transition from content to a data-centric approach and how well are they prepared to do so in the future? What can we learn from those who have achieved this next level of maturity and which system capabilities should we consider key to supporting such a transformation?

    In this webinar Steve Gens, Founder and Managing Partner of Gens & Associates will share a new perspective from the Gens & Associates 2020 World Class RIM benchmark that focuses on those companies who are much further ahead in realizing the promise of a data-driven approach. In their research, they segmented “content” and “data” related RIM capabilities and took just the top performers to understand their journey and how they are investing. Steve will provide a viewpoint to where progressive organizations will be with their RIM programs in the next 3 – 5 years, the path to high performance based on 100 + companies analysis, and a governance model for data quality sustainability.
    Agnes Cwienczek, Amplexor's Head of Product Management and Consulting, will elaborate further on the shift from a content/document-focused towards a data-centric approach and the triggers facilitating the move. She will discuss the key capabilities of a data-driven solution and highlight the benefits to put data first. At the end of the presentation, Agnes will conclude with a demonstration of practical examples of how the Amplexor Life Sciences Suite is addressing the arising data-centric requirements of the industry.
  • Amplexor Life Sciences: Achieving global data, content and process harmonization Recorded: Feb 25 2021 47 mins
    Renato Rjavec, Director of Products - Amplexor Life Sciences
    Prioritizing both quality and efficiency can be a challenge when it comes to being compliant throughout processes.

    Watch Amplexor Life Sciences webinar and find out more about best practices regarding the drug product lifecycle through content management, by prioritizing regulation and productivity.

    In this session, you'll learn:
    - How to improve your decision making;
    - How to support the drug product lifecycle;
    - How to harmonize content and process management;
    …and more.
Amplexor Life Sciences
Amplexor Life Sciences

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  • Title: RIM – Is data-driven Regulatory Information Management your reality?
  • Live at: Apr 7 2021 12:00 pm
  • Presented by: Steve Gens (Gens & Associates) & Agnes Cwienczek (Amplexor)
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