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Online Salon

ヘルスケアDXガイドでは、多様な専門家が集い、DXの取り組みを検討・深化させる“対話の場”です。

ワクチン生産ライン

Online salons for pharmaceutical companies based on their business processes

"Listening to the current state of AI and pharmaceuticals, and imagining the future."
- Supporting on-site issues from a practical and regulatory perspective -

Drug Discovery AI x Molecular Design Salon

[Category] P1: Research and Development [Summary] Introducing the cutting edge of small molecule and bio-drug discovery using generative AI and structure prediction technology [Target audience] R&D, CMC, AI strategy personnel [Benefits] Reducing the number and duration of trials, improving the success rate of new drug development

Decentralized Clinical Trials (DCT) x eConsent Salon

[Category] P2: Clinical trials
[Summary] Introducing DCT to streamline clinical trials, expand patient reach, and streamline regulatory compliance
[Target audience] Development department, CRO, monitors
[Benefits] Reduced burden on subjects, improved testing speed, reduced clinical trial costs

Regulatory Document AI Review x eCTD Automation Salon

[Category] P3: Pharmaceutical application
[Overview] Automatic document composition and review support for application documents and AI-based advance consistency checks
[Target audience] RA, QA, application department
[Benefits] Shorter application lead time and faster review process

Smart Factory x CSA Validation Salon

[Category] P4: Manufacturing/Quality Control [Summary] Introducing the use of IoT/MES in GMP sites and the transition method from CSV to CSA [Target audience] Manufacturing, QA, validation staff, IT department [Benefits] Improved efficiency in audit response, real-time quality control

GDP x IoT Cold Chain Salon

[Category] P5: Distribution and storage [Summary] Sharing examples of real-time logistics monitoring and visualization to prevent temperature deviations and delivery delays [Target audience] Logistics department, wholesale handling, quality assurance department [Benefits] Strengthening traceability, reducing risk of stable supply

MR x Generative AI Utilization Salon (Next Generation Sales Support)

[Category] P6: Sales and Support [Summary] Automatically generate product explanation materials and FAQs using AI to streamline MR activities [Target audience] Sales planning, marketing, MR training [Benefits] Improved visit efficiency, early development of young MRs

Side effect reporting x automatic evaluation AI salon

[Category] P7: Post-marketing safety [Summary] Explanation of support for automatic classification and severity assessment of adverse drug reaction cases in Japan and overseas [Target audience] PV, safety management, RA
[Benefits] Avoiding the risk of reporting delays, reducing man-hours and standardizing

AI Salon: Matching Quality Culture with CDMOs

[Category] P8: Outsourcing/Global Expansion [Summary] Sharing a method for pre-diagnosing "differences in quality culture" during technology transfer and outsourcing manufacturing [Target audience] Technology transfer, QA, outsourcing management departments [Benefits] Prevention of failure risk in transfer projects, visualization of progress

Coming soon!

Online salon for medical devices by modality

"From design to maintenance, our professionals will be there to assist you with any concerns you may have about DX."
- Practical consultation service focusing on regulations, standards, and security -

Image diagnostic AI x SaMD Salon

[Category] M1: Diagnostic medical devices [Summary] Deep dive into SaMD development and regulatory compliance for X-ray, MRI, and endoscopic AI diagnostic software [Target audience] Design and development, RA, AI engineers [Benefits] Ensuring legality of AI development, accelerating market launch

Surgical Assist Robot x UI/UX Design Salon

[Category] M2: Therapeutic medical devices [Summary] Best practices for human-centered design that considers ease of use and prevention of operational errors in the field [Target audience] Design and development, clinical engineering, marketing departments [Benefits] Product design that meets on-site needs, improved adoption rate

IoT medical device x service collaboration salon

[Category] M3: General-purpose medical equipment [Summary] Maintenance and operation monitoring is performed using IoT, and failure prediction and service support are linked. [Target audience] After-sales service, product planning, IT
[Benefits] Reduced maintenance costs and minimized downtime

DTx Approval Strategy x Clinical Evaluation Salon

[Category] M4: Digital medical devices [Summary] Sharing domestic DTx regulatory strategies and methods for building clinical evidence [Target audience] Pharmaceutical affairs, clinical development, and digital staff [Benefits] Smooth approval of innovative DTx products

DTx Approval Strategy x Clinical Evaluation Salon

[Category] M5: IVD
[Summary] Collaborative design and regulatory alignment for accumulating and utilizing test results as RWD [Target audience] Diagnostic drug development departments, RAs, data strategies [Benefits] Increased added value of tests, enhanced product differentiation

Cell products x GMP equipment maintenance salon

[Category] M6: Equipment for regenerative medicine products, etc. [Summary] Explanation of implementation examples of contamination risk reduction and quality maintenance through closed system equipment and automation [Target audience] Manufacturing, QA, equipment development departments [Benefits] Avoidance of quality issues, compliance with regulations, and improved productivity

CGT Manufacturing Support x Automation DX Salon

[Category] M7: Gene therapy product equipment [Summary] Digital control and deviation prevention for devices that support vector manufacturing and cell manipulation [Target audience] CGT manufacturing, bioengineers, QA
[Advantages] Improved scalability, guaranteed safety and reproducibility

Medical device UDI/GS1 compliant salon

[Category] M8: Common/Cross-modality [Summary] Explains everything from GS1 code design to UDI system compliance from a multinational perspective [Target audience] RA, quality assurance, product master management department [Benefits] Supports global expansion, strengthens traceability

Coming soon!
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