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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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  • Enabling efficient Submission Content Management & Publishing Oct 28 2021 12:00 pm UTC 61 mins
    Agnes Cwienczek, Head of Product Management and Consulting at Amplexor Life Sciences
    Find out how companies can improve business agility by producing and managing compliant, high-quality submissions in a cost and time-efficient manner.

    Submission Management & Publishing is a critical activity in Regulatory Operations with an ever-increasing need for cost and time efficiency while accommodating the flexibility to quickly react to changes or urgent submission needs. It became an essential part of the overall Regulatory Information Management process throughout the past years, instead of being an isolated domain in the operations space.



    Many companies succeeded in establishing well-defined Submission Content Management & Publishing processes stretching from the global to the local organisation, including many processes and content contributors and consumers like the service providers supporting the company’s delivery needs. Recently, additional attention is being paid towards automation of routine tasks within and beyond Submission Content Management & Publishing activities to further improve efficiency and reduce human errors.
  • Quality Management Crossroads Recorded: Sep 23 2021 61 mins
    Siniša Belina, Senior Life Sciences Consultant, Amplexor
    The complexity of everyday operations in the Life Sciences industry is constantly increasing. To keep up with the regulatory requirements while upkeeping quality, efficacy and safety of products in focus, companies are required to constantly re-visit their approach to processes, technology and information. Staying flexible and agile is key in obtaining success in this industry.

    In this webinar, we will take a look at new trends in the market, learn about the potential and opportunities of implementing holistic quality management platforms. We’ll take a look at those that seamlessly link not only activities within QA/QC departments, but also merge them into the comprehensive process that includes R&D, manufacturing, regulatory, labeling and other internal and external stakeholders.

    Join us to learn more about how to manage process dependencies (from a deviation, through CAPA, over change management, supplier management all the way to regulatory impact assessment and submission of variations), cope with the transition from the classic monolithic document-centric world towards the data-driven and structured environment of the future, and use the power of intelligent analytics to stay in control of your processes.
  • Now that IDMP is real, is your RIM roadmap on the right track? Recorded: Jul 29 2021 55 mins
    Renato Rjavec, Director of Products - Amplexor Life Sciences
    After all the theorizing and preparing for, IDMP is suddenly real (in Europe, at least). But compliance will be a staged, iterative affair as requirements evolve.
    The key, then, is to establish whether your organization is on the right path to ensure long-term alignment with the demands of IDMP. And for each company, the starting point will differ.
    Join our experts in this webinar, we’ll set out the most common scenarios pharma companies will typically be starting from, exploring the options in each case.

    Scenario 1: No formal RIM system currently in place
    Scenario 2: Existing RIM investment: build on it – or start afresh?
    Scenario 3: Single RIM vendor vs best-of-breed applications – can IDMP solution be implemented into the existing RIM landscape?

    In the webinar, we’ll work through each scenario, discussing the different options – and explore the merits of performing a low-risk/low-cost IDMP proof-of-concept alongside those existing RIM set-ups to check the preferred choice is fit for purpose.
  • Structured Content Authoring:​ New Long Term Solutions (Medical Device Industry) Recorded: Jul 7 2021 35 mins
    Kathleen O’Brien, Director of Business Development and Pepijn Mul, ECM Consultant
    The traditional document publishing approach most companies use for authoring and publishing is outdated and bring many challenges because they work with locked file formats.
    These tools make it hard to reuse content efficiently, make changes and updates easily, and force you to manual format each document, making you lose time and money.

    Meet our experts to discover why traditional production tools and processes come up short for content authoring and how you can combat this while keeping up with regulatory changes, increase in content volume and time-to-market acceleration.
  • Now that IDMP is real, is your RIM roadmap on the right track? Recorded: Jul 1 2021 55 mins
    Renato Rjavec, Director of Products - Amplexor Life Sciences
    After all the theorizing and preparing for, IDMP is suddenly real (in Europe, at least). But compliance will be a staged, iterative affair as requirements evolve.
    The key, then, is to establish whether your organization is on the right path to ensure long-term alignment with the demands of IDMP. And for each company, the starting point will differ.
    Join our experts in this webinar, we’ll set out the most common scenarios pharma companies will typically be starting from, exploring the options in each case.

    Scenario 1: No formal RIM system currently in place
    Scenario 2: Existing RIM investment: build on it – or start afresh?
    Scenario 3: Single RIM vendor vs best-of-breed applications – can IDMP solution be implemented into the existing RIM landscape?

    In the webinar, we’ll work through each scenario, discussing the different options – and explore the merits of performing a low-risk/low-cost IDMP proof-of-concept alongside those existing RIM set-ups to check the preferred choice is fit for purpose.
  • How Regulatory Information Management Systems can support Life Sciences Recorded: Jun 16 2021 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 Recorded: May 27 2021 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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