Amplexor Life Sciences Q4 Product Update

Amplexor Life Sciences Q4 Product Update

WEBINAR ON DEMAND

Amplexor Life Sciences Product Update: Q4/2022

Watch this customer-exclusive webinar where you’ll be able to learn about our recent product enhancements and future plans. 

The webinar will provide an in-depth view on some of the key features released in 7.0 including: 

  • Active substance registrations
    • Medical device registrations
    • Facility registrations
    • Data model updates according to IDMP IG 2.1.1
    • Advanced data impact assessment with bulk updates
    • China eCTD submisions
    • Import of EAEU submissions
    • Flexible import of digitally signed documents
    • Many other improvements
About the speaker
Renato Rjavec

Renato Rjavec

Director of Product Management

As Director of Product Management, Renato is responsible for Amplexor Life Sciences Solution Product Management. Over the last fifteen years with the company, he held several positions within the delivery and product management organization where he acquired broad experience in analyzing, designing and implementing end-to-end regulatory solutions for the global Life Sciences industry.

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Can’t Stop the Audit Trail!

Can’t Stop the Audit Trail!

WEBINAR ON DEMAND

Can’t Stop the Audit Trail!

In this webinar you will learn:

  • What is audit trail, and why would you need one?
  • Why is it important for businesses to maintain a comprehensive and complete audit trail
  • What are the audit trail benefits which go beyond compliance
  • How does audit trail look in practice

The webinar will conclude with a demonstration of the AMPLEXOR Life Sciences Suite and its audit trail capabilities.

About the speakers
Vanja Primorac

Vanja Primorac

ALSS Business Consultant

As a Life Sciences Consultant, Vanja is responsible for the contribution to the development and enhancement of the Amplexor Life Sciences Suite, as well as the provision of business process and data management expertise to Amplexor clients in the area of Quality Assurance.

Before joining Amplexor, Vanja worked in GlaxoSmithKline, where she was holding the position of Senior Quality Executive and Responsible Person.

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5 Major Efficiency Boosts for Your Regulatory Operations

5 Major Efficiency Boosts for Your Regulatory Operations

WEBINAR ON DEMAND

5 Major Efficiency Boosts for Your Regulatory Operations

One of the key goals of RegOps leaders is to constantly improve efficiency of regulatory operations. It may be through process optimizations, improved toolsets, outsourced services or other means

 

About the webinar
  • This webinar will focus on 5 capabilities that a modern holistic RIM system can provide to greatly improve efficiency of regulatory data, content and process management and consequently incur substantial cost savings while retaining same or even increase the quality of final outputs
      About the speakers
      Renato Rjavec

      Renato Rjavec

      Director of Products

      As Director of Products, Renato is responsible for Amplexor’s Life Sciences Solution Product Management. Over the last fifteen years with the company, he held several positions within the delivery and product management organization where he acquired broad experience in analyzing, designing and implementing end-to-end regulatory solutions for the global Life Sciences industry.

      Get in touch with an expert

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      Get in touch

      Want to learn more about Amplexor and our industry-leading solutions? Drop us a line!

      EU IDMP Implementation: DADI and the agile way forward ​

      EU IDMP Implementation: DADI and the agile way forward ​

      WEBINAR ON DEMAND

      EU IDMP Implementation: DADI and the agile way forward 

      Beginning of this year, European Medicines Agency (EMA) has finally broken cover and publicly confirmed the closed circle information and rumors spreading in the previous months: the DADI (Digital Application Dataset Integration) project will now serve as the ‘agile Plan’ to move forward with the implementation of regulatory data submissions as the way to achieve the planned PMS go-live.

       

      About the webinar

       In this webinar, we’ll discuss and learn about:

      • the DADI project and how it relates to the EU IDMP Implementation
      • our key takeaways – what DADI will support and won’t deliver
      • the impact of DADI on the industry 
      • how to respond to the change and adjust plans for a data-driven regulatory future if needed
        About the speakers
        Agnes Cwienczek

        Agnes Cwienczek

        ALSS Head of Product Management and Consulting

        Agnes has been in the position of ALSS Head of Product Management and Consulting since May 2017. Her main responsibilities are the contribution to the development and enhancement of the Amplexor Life Sciences Suite, supervision of the Life Sciences Consultants as well as the provision of business process and data management expertise to Amplexor clients in Regulatory Information Management, Document Management, and Submission Management.

        Before joining Amplexor, Agnes worked at Merck KGaA in Global Regulatory and Quality Assurance, where she was acting System and Process Owner for all regulatory owned systems, providing global leadership for the management of submission documents, regulatory data and archiving within the Merck Biopharma organization.

        Get in touch with an expert

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        Amplexor Life Sciences Q4 Product Update

        Amplexor Life Sciences Product Update Q2/2022

        WEBINAR ON DEMAND

        Amplexor Life Sciences Product Update: Q2/2022

         Watch this customer-exclusive webinar where you’ll be able to learn about our recent product enhancements and future plans. 

        The webinar will provide an in-depth view on some of the key features released in 7.0 including: 

        • IDMP data model with advanced data management
        • Redesigned submission planning, compilation and publishing
        About the speaker
        Renato Rjavec

        Renato Rjavec

        Director of Products

        As Director of Products, Renato is responsible for Amplexor’s Life Sciences Solution Product Management. Over the last fifteen years with the company, he held several positions within the delivery and product management organization where he acquired broad experience in analyzing, designing and implementing end-to-end regulatory solutions for the global Life Sciences industry.

        Get in touch with an expert

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        Amplexor Life Sciences Q4 Product Update

        Now that IDMP is real, is your RIM roadmap on the right track?

        WEBINAR ON DEMAND

        Now that IDMP is real, is your RIM roadmap on the right track?

        After all the preparations for IDMP, it’s here. 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.

        About the 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.

        About the speakers
        Renato Rjavec

        Renato Rjavec

        As Director of Product Management, Renato is responsible for Amplexor’s Life Sciences product portfolio, focusing on customer value, innovation, quality and compliance. He has been with the company for 14 years, previously working on analysis, design, development and delivery of end-to-end regulatory and quality solutions for the Life Sciences industry.

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        Product information in life sciences: 5 things you should know

        Get in touch with an expert

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