A warm welcome to the Autumn edition of our AB Cube newsletter.
In this issue, we lead with the exciting news that Morten Kjær has joined the AB Cube executive team as our new Chief Commercial Officer. As former CEO of BaseCon, Morten brings vast commercial and leadership experience in the PV space, and we’re thrilled to welcome him on board as we expand our mission to deliver transformative vigilance solutions to the global safety industry.
Our latest customer success stories explore how our customers Air Liquide and Septodont are gaining from SafetyEasy® Suite’s scalable, automated efficiency – achieving effortless pharmacovigilance compliance thanks to our best-in-class, single-platform PV safety database with intelligent automation features.
We also highlight the latest key regulatory developments in North America and Europe, plus spotlight two new downloads that are available from our website: our brand-new Galaxy next-gen AI modules overview and Medical Device Safety Database brochure.
Finally, we review three key industry events that we were delighted to have a presence at this autumn conference season – Pharmacovigilance World in London, ISoP in Montréal and World Drug Safety Congress Europe in Amsterdam.
If you missed us at the recent shows and you’re keen to get up to speed on how our solutions are leading the way in automation, integration and ease of use, simply email [email protected] today to schedule a SafetyEasy® Suite demo for your safety team.
We hope you enjoy reading this edition, and we look forward to connecting with you very soon.
Best regards,
Matthieu Doresse
Founder & CEO, AB Cube
+33 185 34 94 79
[email protected]
Follow us on X: @abcube1
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AB CUBE NEWS: Introducing our new Chief Commercial Officer
We are thrilled to announce that Morten Kjær has joined AB Cube as our new Chief Commercial Officer (CCO). Morten will oversee all client relations, new business ventures, and general commercial activities. He will spearhead our global Business Development and Key Account Management efforts.
Morten brings a wealth of experience to our team, having previously served as the CEO of BaseCon, a leading Danish PV software provider. With over 17 years in the PV industry, Morten possesses exceptional leadership skills and extensive knowledge in managing PV clients across Europe.
Please join us in welcoming Morten to the AB Cube family!
Regulatory update – North America: US FDA heads to E2B(R3) format for Combination Products Submissions
The US regulatory landscape for Combination Products e-submissions is changing.
Currently, e-submissions can be made using the eMDR (XML HL7) format, with paper submissions possible through MedWatch. The FDA has adopted the International Medical Device Regulators Forum (IMDRF) dictionary but still accepts the respective FDA MDR AE codes in the eMDR or MedWatch.
In 2021, the FDA introduced guidelines on Combination Products to enable a single submission of cases involving products combining two or more vigilances – Pharmacovigilance, Biovigilance and Medical Devices Vigilance. This new regulation had an impact on the XML E2B (R2) submission file formats.
The new E2B(R3) format for FDA Combination Products will be implemented in AB Cube’s SafetyEasy® Suite in 2025 – ahead of estimated mandatory application in March 2026. If you have any questions about medical device vigilance or Combination Products e-submissions, just get in touch with your AB Cube support team – we’re here to help.
Regulatory update – Europe: Swissmedic migrates ICSR submission system to E2B(R3)
Swissmedic – Switzerland’s national authorisation and supervisory authority for drugs and medical products – recently informed MAHs about plans to migrate its ICSR submission systems from E2B(R2) to E2B(R3) format. The transition to the new reporting process is expected to begin by the end of September 2024.
The Electronic Vigilance System (ElViS) cannot be adapted to the R3 format, so all MAHs currently using ElViS and able to exchange ICSRs in E2B(R3) are being recommended to migrate to the Swiss B2B Gateway.
AB Cube continues to support our customers through the changing regulatory environment, with our first customer user of the Swiss Gateway smoothly moved to production in May 2024. If your organization is looking to implement a gateway connection with Swissmedic, our expert team is ready to support you.
New resource! Download our next-AI gen Galaxy modules brochure
Our new AB Cube Galaxy brochure is now live.
Discover how your organization can reduce manual processes and enhance efficiency, compliance and signal detection with our next-AI gen Galaxy modules – available as add-ons to our industry-leading SafetyEasy® multivigilance suite.
SafetyEasy® Suite empowers your safety team to:
🔹Simplify & speed up case intake
🔹Gain case creation efficiency
🔹Enhance case analytics
🔹Improve signal detection
🔹Automate ICSR processing
🔹Seamless system connectivity
🔹Boost compliance
Download our new brochure and find out how our new Galaxy modules can enrich your SafetyEasy® multivigilance platform with enhanced efficiency and compliance.
Book a demo now!
New resource! Download our Medical Device Safety Database brochure
Our new Medical Device Safety Database brochure is now available.
AB Cube is trusted by industry leaders to deliver a total medical device vigilance solution spanning:
🔹Vigilance across all 3 classes of Medical Devices
🔹Integration of IMDRF & FDA MDR AE Codes within single coder
🔹Generation of MedWatch PDF or eMDR (XML HL7) for US cases
🔹Generation of MIR PDF or XML for post-market cases in EU
🔹Generation of MDCG 2020-10/2 for EU Clinical Investigation cases
🔹FDA Combination products
Download our new brochure today and explore how SafetyEasy® Suite can support your organization’s medical device safety needs.
NEW customer case study: Air Liquide
“SafetyEasy® Suite is a robust system that is always evolving to meet our needs. With AB Cube, we are saving time.”
For more than a decade, Air Liquide Healthcare has relied on AB Cube’s SafetyEasy® Suite and its scalable, automated efficiency to ensure effortless pharmacovigilance compliance across its global health activities.
Discover how Air Liquide Healthcare’s safety team is gaining from intelligent automation features and a best-in-class, single-platform PV safety database that is adapted to its organizational needs, delivering key business benefits:
🔹Intuitive and easy to use system
🔹Custom data extraction
🔹Simplifies PV operations
🔹Streamlines day-to-day PV operations
🔹Accelerates reporting
🔹Reduces manual effort and resources
Download the full case study to find out more.
NEW customer case study: Septodont
“We always feel important as a customer. If AB Cube does not have a solution, they will find a solution.”
Read our latest customer success story spotlighting our intuitive vigilance solution implemented for Septodont – a world leader in dental pain management and a pioneer of innovative biomaterials.
Discover how our SafetyEasy® Suite is providing a flexible, evolutive and responsive pharmacovigilance management solution for Septodont’s PV team, offering key business benefits:
🔹Logical and easy to use system
🔹Seamless data integration
🔹Simplifies PV operations
🔹Speeds case processing
🔹Saves valuable time
Download the case study now.
INDUSTRY NEWS: Qlik recognized in Gartner Magic Quadrant™
Congratulations to Qlik on its latest recognition in the Gartner Magic Quadrant™ for Analytics and Business Intelligence Platforms.
For the 14th consecutive year, the data visualization and discovery technology provider has been named as a Leader by Gartner in this key quadrant, with continuous innovation and AI advancements across its data and analytics solutions at the core of its success.
Commenting on the achievement, Qlik CEO Mike Capone said: “Our consistent recognition as a Leader by Gartner highlights our relentless dedication to innovation, helping our customers to capture the opportunity that AI presents. We equip businesses with the analytics tools they need to harness AI effectively, transforming data into competitive advantage.”
AB Cube is leveraging the company’s Qlik Sense® technology to drive our Business Intelligence (BI) module – one of the newest additions to our extended AB Cube Galaxy. Our powerful BI solution helps you enhance your company efficiency and increase compliance by visualizing your scientific data, thanks to advanced dashboards. For more information, check out our AB Cube Galaxy brochure.
AUTUMN CONFERENCES: EVENT REVIEWS
Pharmacovigilance World, London, 11-12 September 2024
Our team headed to London in September to attend UK drug safety conference Pharmacovigilance World. The conference presentations throughout the two-day event were high-value and informative, with a clear focus on how to optimize PV and risk management strategy in an evolving drug safety environment. Key PV streams included Global PV & Methodologies, PV Automation, AI & Machine Learning, and Data Management & Analytics in PV.
It was fantastic to catch up with many of our associates, and to make new connections within the pharmaceutical, biotechnology and devices industries who are actively looking for advanced vigilance solutions to optimize compliance and growth.
ISoP, Montréal, Canada, October 1-5 2024
Earlier this month we were in Montréal, Canada for another highlight event of the PV calendar – the 23rd International Society of Pharmacovigilance (ISoP) Annual Meeting 2024.
The theme of this year’s meeting was “Global Perspectives on Pharmacovigilance in the Digital Age and Advanced Therapeutics”. For 2024, the ISoP Scientific Committee placed the application of new technologies and the safe use of advanced therapeutics right at the heart of the scientific program – inviting regulators, ISoP SIGs, world-leading academic and global pharmacovigilance leaders from the pharmaceutical Industry to contribute their insights to this timely focus.
AB Cube exhibited at the event as a main sponsor, and we were very pleased to unveil to attendees our new brochure for our next-gen AI Galaxy modules, which add enhanced capabilities to our SafetyEasy® Suite solution. Thanks to the organizers for an excellent event, with an insightful and wide-ranging conference program. We’re looking forward to returning next year!
World Drug Safety Congress Europe, Amsterdam, October 9-10 2024
WDSC Europe is always a must-attend event, and our booth at the show was consistently busy and bustling as the industry’s safety professionals came together to discuss solutions to the key challenges in PV. Interest was high in our innovative pharmacovigilance software and AI-driven modules that are transforming the daily workflows of our users, and we’ll be following up on a number of exciting opportunities.
If you missed us at any of our recent events, just get in touch and let’s arrange a time to talk about how AB Cube can enhance your processes and make your work smoother!
