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.

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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.

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        Amplexor Life Sciences Product Update Q2/2022

        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 Product Update Q2/2022

        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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        Get in touch with an expert

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        Challenges and best practices for global patient engagement

        Challenges and best practices for global patient engagement

        WEBINAR ON DEMAND

        Challenges and best practices for global patient engagement

        Global clinical trial success hinges on culturally appropriate patient engagement.

        Discover best practices to recruit and retain study patients in global clinical trials as well as delve into the biggest challenges in this area today.

         

         

         

         

        About the webinar

        Join our experts as they share their real-world experiences and successes with global and cultural adaptation for effective patient recruitment and retention.

        These experiences touch on methods to overcome geographical, financial and educational barriers. Learn how your language service provider can support culturally appropriate and medically accurate language services and partnerships between study operations.

        About the speakers
        Stéphane Millet

        Stéphane Millet

        Stéphane is responsible for developing strategic processes that will drive operational excellence within the Acolad Group and for ensuring the optimization of workflows and localized content for a highly regulated industry. Prior to joining Acolad in 2010, Millet worked as a translator and localization project manager in diverse operational functions. He is also a graduate of the faculty of translation studies, linguistics and cultural studies of the Johannes Gutenberg University in Mainz/Germersheim, Germany.

         

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        7 use cases for VR exploration of regulated life sciences data

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        Unlocking the business benefits of text mining in regulatory operations

        Unlocking the business benefits of text mining in regulatory operations

        WEBINAR ON DEMAND

        Unlocking the business benefits of text mining in regulatory operations

        Find out how companies can approach IDMP data collection and quality challenges and decrease associated costs.

        Learn how your company can reach major time and cost savings as well as other business benefits using advanced text mining in the context of regulatory information management.

        About the webinar

        With the advance of IDMP implementation, data is becoming a key asset for the life sciences industry. Pharma companies are currently focusing on the heavy burden of initial IDMP data collection, but looking ahead, data maintenance will become their prevalent issue. This can only be tackled by maintaining the quality and integrity of data at all times. Making sure your data and content are always up to date, and FHIR messages are fully aligned with the content of submitted eCTD sequences, would bring major time and cost savings as well as other business benefits for the industry.

        Advanced text mining technologies in the context of end-to-end RIM can support the current and future regulatory operations challenges alike. You are kindly invited to attend our webinar where some of those challenges, as well as their respective solutions, will be presented by Kelly Hnat from K2 Consulting, Hanno Ebsen from Averbis, and Renato Rjavec from Amplexor.

        About the experts
        Kelly Hnat

        Kelly Hnat

        Kelly is a leader in RIM and IDMP with 25 years’ experience in the biopharmaceutical industry leading IT, RIM, and Regulatory Operations organizations. Kelly is a globally recognized expert in IDMP and is a key subject matter expert supporting the EU implementation of IDMP as a member of the EMA SPOR Task Force, the SPOR PMS subteam, and the SPOR EU Implementation Guide Focus Groups. Additionally, she is a member of ISO TC215/WG6 (the ISO group responsible for the IDMP standards), is a member of the Core Research Team for the Gens & Associates World Class RIM survey, and serves as President and CEO of IRISS Forum, a global nonprofit organization that brings together industry, vendors, and health authorities to address topics related to submission standards. Kelly is the founder of K2 Consulting, a boutique consultancy that provides business process, organizational strategy, and technology strategy services for Regulatory Affairs organizations.

        Hanno Ebsen

        Hanno Ebsen

        Hanno holds a Master’s degree in Psychology and has more than 18 years of experience in the life science industry. After 15 years in management at a consulting firm, he moved into AI product development for pharma. At Averbis, he is the first point of contact for customers in the Life Sciences sector.

        Renato Rjavec

        Renato Rjavec

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        On-demand webinars

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

        Get in touch with an expert

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