Welcome to the Autumn 2025 edition of the AB Cube newsletter!
We’re excited to kick off this issue with highlights from our September 16 webinar, where we were thrilled to unveil our new Medical Information Management Module (MIM). Catch our teaser video on LinkedIn to see how MIM is redefining medical information management — making it smarter, faster, and future-ready. Missed the launch? Let’s get you up to speed.
Hot on the heels of our recent rebranding and the launch of our modular approach to the SafetyEasy® Suite, we’ve released a fresh set of brochures showcasing the advanced capabilities and transformative features now available across the SafetyEasy® universe. Download the complete set directly from our website today.
In our Regulatory Update, we highlight essential news of evolving global pharmacovigilance and medical device vigilance requirements — from new submission formats and reporting deadlines to data privacy mandates and language support expansions. We also spotlight new improvements to our SafetyEasy® product suite, designed to support compliance, streamline workflows, and enhance inspection readiness.
Finally, we take a moment to reflect on a whirlwind autumn conference season and our buzzing stand presence at three of our favourite industry events – World Drug Safety Europe in Amsterdam, the ISoP 2025 Annual Meeting in Cairo, and World Drug Safety Congress Americas in Boston.
Interested in discovering how our AI-powered solutions can elevate your safety team’s efficiency? Book a meeting with us at the show or schedule a SafetyEasy® Suite demo by contacting sales@ab-cube.com.
We hope you enjoy this edition and look forward to connecting with you — whether in person, online, or at an upcoming industry event soon.
Best regards,
Matthieu Doresse
President/ CEO
AB CUBE NEWS: Medical Information Module launch
What if your medical information process could virtually run itself?
Imagine a world where every inquiry, every call is seamlessly captured, processed, and transformed into actionable insights — all within your pharmacovigilance system.
We were thrilled to unveil AB Cube’s new Medical Information Management (MIM) Module during our live webinar on September 16. A big thank you to everyone who attended and contributed to the discussion!
Watch our teaser video on LinkedIn see how MIM is changing the game and making medical information management smarter, faster, and future-ready.
So what’s inside the module?
- Fully integrated directly into SafetyEasy™ — no extra tools, no extra hassle
- Custom fields creation – tailored workflows for your team
- Zendesk as standard – or any call center via API – with flexible and seamless integration to match your setup
- AI-powered automation – transcription & smart answer generation
- From first contact to case creation — all in one flow
- Real-time efficiency – zero manual data entry, all speed
MIM marks a major step forward in simplifying and accelerating medical information management — while staying fully compliant and connected with pharmacovigilance.
If you missed the launch webinar or would like to schedule a personalized demo, feel free to reach out at sales@ab-cube.com
AB CUBE NEWS: Brochures, brochures, brochures!
Hot on the heels of our recent rebranding and the launch of our new modular approach for SafetyEasy® Suite, we’ve released a brand-new set of brochures to help you explore the advanced capabilities and transformative feature sets available within our SafetyEasy® universe.
Download the complete set now from our website:
SafetyEasy® Vigilance: Explore how our SafetyEasy® Vigilance solution helps your safety team effortlessly manage and efficiently process all of your key vigilances.
IntakeEasy Solution: Discover IntakeEasy – Your Suite of Optional Modules to automate Data Capture and Case Creation. This solution offers end-to-end automation.
Business Intelligence Solution: Harness the power of dynamic data visualization with Business Intelligence – Your SafetyEasy® Suite Data Analytics Solution.
For a refresher on our new modular approach, head to our new one-page brochure, and keep an eye on our website for an upcoming new look.
REGULATORY UPDATE: Essential PV, MD and product development news
In our regular Regulatory Update feature, we bring you an overview of the key changes and enhancements happening across the global regulatory landscape in pharmacovigilance and medical device vigilance, as well as news of the latest updates to our SafetyEasy® product suite.
From new submission formats and reporting deadlines to data privacy mandates and language support expansions, we highlight the essential developments you need to know. Plus, we also spotlight our newest product improvements designed to support compliance, streamline workflows, and enhance inspection readiness.
Whether you’re managing drug safety, device vigilance, or system configuration, we can help you stay informed and prepared.
Regulatory Updates – Pharmacovigilance
- Case Deadline Redesign
New Drug Deadlines have been added to the standard configuration:
- 90-Day deadline for submitting non-serious ICSRs to the MHRA (UK)
- 60-Day deadline for submitting non-serious ICSRs to Swissmedic (Switzerland)
These enhancements are aimed at ensuring better alignment with national regulatory expectations and improve compliance tracking.
- E2B(R3) ICSR Submissions
- Swissmedic: Now supports E2B(R3) ICSR submission for drugs
- FDA: Extended support for E2B(R3) ICSR and SUSAR submissions for drugs and biologics (excluding vaccines)
The new submission formats streamline electronic reporting and enhance seamless integration with global health authorities.
- EMA Pseudo-Anonymization
Systematic pseudo-anonymization of XML E2B(R3) files has now been implemented for submissions to the EMA, in accordance with EU GVP Module VI Addendum II, which establishes a unified policy for masking personal data in Individual Case Safety Reports submitted to EudraVigilance, effective as of July 25, 2025. This move ensures privacy compliance and data protection in line with EU standards.
- MedDRA Language Expansion
To support broader accessibility and localization for safety data coding, MedDRA now includes two additional languages: Norwegian and Slovak.
Regulatory Updates – Medical Devices
- New MIR for UK
A new Manufacturer Incident Report (MIR) template has been introduced for the UK, following implementation of the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024, and aligning with post-Brexit regulatory frameworks and improving incident reporting clarity.
- Second Safety Report for IVDMD
The MDCG 2024-04 guidance introduces the second Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746 – April 2024). The new guidance reflects evolving EU vigilance expectations and strengthens lifecycle safety monitoring.
SafetyEasy® Suite: Product Enhancements
- IntakeEasy – Pre-Case WebForm
Our IntakeEasy solution now supports a Pre-case module and a WebForm module, enabling early intake of safety information and improving case triage efficiency.
- Case Audit Trail Redesign
The Case Audit Trail has been redesigned to offer:
- Enhanced traceability
- Improved usability for inspections and audit
This product enhancement strengthens regulatory audit preparedness and elevates internal quality assurance.
EVENT REVIEW 
Autumn Highlights: AB Cube on the road at three global pharmacovigilance Events
It’s been a whirlwind October and November for the AB Cube team, with a packed travel schedule and a strong exhibiting presence at three must-attend industry events:
- World Drug Safety Congress Europe in Amsterdam
- ISoP 2025 Annual Meeting in Cairo
- World Drug Safety Congress Americas in Boston
We extend our warm thanks to everyone who stopped by our stand to explore the SafetyEasy® Suite and experience our automated pharmacovigilance modules in action.
These events provided an invaluable forum to engage with the global drug safety community, exchange insights, and showcase how AB Cube continues to push the boundaries of pharmacovigilance innovation.
Key Takeaways from the road
Across these three events, we had the pleasure of connecting with a diverse range of stakeholders in the pharmacovigilance ecosystem:
- Academic researchers presenting cutting-edge scientific posters and exploring automation in safety data analysis
- CROs looking to streamline PV operations for their sponsors
- Pharmaceutical companies launching new PV projects and seeking scalable, compliant solutions
- Regulatory professionals interested in real-time reporting and global compliance features
These conversations reaffirmed the growing demand for intelligent automation, modular flexibility, and cloud-native platforms in pharmacovigilance workflows.
Looking Ahead
We’ve been incredibly energized by the feedback and collaborations sparked during these events and we’re looking forward to continuing the conversation. Whether you’re exploring automation, preparing for a PV system upgrade, or launching a new safety initiative, SafetyEasy® Suite is ready to support your journey.
See you at the next one!
