IDMP CEE 2nd workshop: IDMP CEE Progress and Plans by Sabina Bokal
40% 4 of Top 10 · Management Health Authority interactions Obligations & Commitments Data...
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THE FUTURE OF REGULATORY INFORMATION MANAGEMENT “RIM is being viewed as an Enterprise Asset and RIM systems must be able to exchange information with other critical enterprise capabilities (e.g., ERP) real time.” “…As companies connect to other functional areas and apply artificial intelligence and predictive analytics methods, we should witness growing strategic value, operating efficiency and reduced compliance risk as a natural outcome.” - GENS & Associates* LifeSphere ® Regulatory Integrating Compliance with Regulatory Processes Over the Entire Product Lifecycle Performance metrics, KPIs, reports and analyses for improved efficiency Streamlined publishing and content management Global data standards compliance (xEVMPD, IDMP, UDI and beyond) Intuitive, end-to-end handling of all regulatory affairs processes by headquarters, regulatory operations, regional managers and local affiliates LifeSphere RIMS LifeSphere IDMP LifeSphere Publishing LifeSphere Analytics Increasing Compliance Audits Planning & Tracking Inefficiencies Low Affiliate RIM Adoption Obsolete Software & Costly Upgrades Complex Global Regulatory Requirements Lack of Cross-Department Visibility Low Data Quality Confidence Limited, Real-Time Submissions Visibility 1 2 3 4 Current Challenges Based on 4 Key Tenets: Open Architecture – Multi-Tenant Cloud – Cognitive Computing & Automation – Industry Standard Practices Current Challenges Delivering Powerful Benefits Provides real-time visibility of regulatory activity Strengthens data quality with reduced workload Enhances demand forecasting, submission planning & performance tracking Improves cross-department integration efficiencies Increases affiliates participation for global RIM rollouts Lowers total cost of ownership & avoids upgrade headaches Product & Clinical Trial Registrations Submissions Planning & Tracking Global Change Management Health Authority interactions Obligations & Commitments Data Stanndards Compliance xEVMPD, IDMP, UDI Document & Dossier Management Publishing Business Analytics Regulatory Intelligence* Label Management* Cloud-Based SaaS Learn how leading pharmaceutical, biotech, contract research organizations and health authorities are transforming Regulatory Affairs with LifeSphere Regulatory. www.arisglobal.com/products/lifesphere-regulatory/ USED BY Customer Successes 30+ Pharmas and CROs worldwide 10 of Top 50 5 of Top 20 4 of Top 10 40% 25% 20% *World Class Regulatory Information Management Whitepaper; Connections to Supply Release, Product Change and QMS - 2018 Fall Edition *Upcoming modules © 2019 ArisGlobal LLC. All rights reserved. All trademarks are the property of their respective owners and are acknowledged as such.
Transcript of 40% 4 of Top 10 · Management Health Authority interactions Obligations & Commitments Data...
THE FUTURE OF REGULATORYINFORMATION MANAGEMENT
“RIM is being viewed as an Enterprise Asset and RIM systems must be able to exchange information with other critical enterprise capabilities (e.g., ERP) real time.”
“…As companies connect to other functional areas and apply artificial intelligence and predictive analytics methods, we should witness growing strategic value, operating efficiency and reduced compliance risk as a natural outcome.”
- GENS & Associates*
LifeSphere® Regulatory
Integrating Compliance with Regulatory Processes Over the Entire Product Lifecycle
Performance metrics, KPIs, reports and analyses for improved e�ciency
Streamlined publishing and content management
Global data standards compliance (xEVMPD, IDMP, UDI and beyond)
Intuitive, end-to-end handling of all regulatory a�airs processes by headquarters, regulatory operations, regional managers and local a�liates
LifeSphere RIMS
LifeSphere IDMP LifeSphere Publishing
LifeSphere Analytics
Increasing Compliance Audits
Planning &Tracking Ine�ciencies
Low A�liate RIM Adoption
Obsolete Software & Costly Upgrades
Complex Global Regulatory Requirements
Lack of Cross-Department Visibility
Low DataQuality Confidence
Limited, Real-Time Submissions Visibility
1
2 3
4Current Challenges
Based on 4 Key Tenets: Open Architecture –
Multi-Tenant Cloud – Cognitive Computing & Automation – Industry Standard Practices
Current Challenges
Delivering Powerful Benefits
Provides real-time visibility of regulatory activity
Strengthens data quality with reduced workload
Enhances demand forecasting, submission planning & performance tracking
Improves cross-department integration e�ciencies
Increases a�liates participation for global RIM rollouts
Lowers total cost of ownership & avoids upgrade headaches
Product & Clinical Trial Registrations
Submissions Planning & Tracking
Global Change Management
Health Authority interactions
Obligations & Commitments
Data Stanndards Compliance xEVMPD, IDMP, UDI
Document & Dossier Management
Publishing
Business Analytics
Regulatory Intelligence*
Label Management*
Cloud-Based SaaS
Learn how leading pharmaceutical, biotech, contract research organizations and health authorities are transforming Regulatory Affairs with LifeSphere Regulatory.
www.arisglobal.com/products/lifesphere-regulatory/
USED BY
Customer Successes
30+ Pharmas and CROs worldwide
10 of Top 50
5 of Top 20
4 of Top 1040%
25%
20%
*World Class Regulatory Information Management Whitepaper; Connections to Supply Release, Product Change and QMS - 2018 Fall Edition *Upcoming modules © 2019 ArisGlobal LLC. All rights reserved. All trademarks are the property of their respective owners and are acknowledged as such.
