The document discusses the challenges in pharmacovigilance and risk management, highlighting a trend towards active pharmacovigilance using intelligent intake technology to improve decision-making. It emphasizes the need for quality data collection in the evolving landscape and the importance of meeting risk management commitments through innovative processes and automation. The implementation of this technology is presented as a scalable solution that can adapt to organizational changes and reduce costs.

1. Arena 11th Annual
Pharmacovigilance, Drug Safety and
Risk Management
1-2 December, Brussels
Driving risk management through intelligent intake technology
Moving from passive to active pharmacovigilance to fuel better decision-making
Dr. Andrew Rut
Chief Executive Officer,
MyMeds&Me

2. © MyMeds&Me 2015
Focus of today’s presentation
• Pharmacovigilance and risk management challenges
• Evolving PV landscape
• Addressing the challenges:
 Quality
 Moving from passive to active PV
 Meeting your risk management commitments
• Reviewing the possible architecture
• Aglimpse of the technology
• Implementation benefits

3. © MyMeds&Me 2015
PV and Risk Management Challenges
Report Volumes increasing 20 % year on year
• Traditional routes of Spontaneous now significantly accentuated by PSPs, Market
support and growth across emerging economies
• Most reports are of listed events often non-serious
• Central teams struggle to meet resourcing requirements
RMP commitments increasing across diverse portfolios
• NCEs, Biologics, Vaccines etc
Patient expectations
• Far greater expectation of more direct relationship with patients for key brands
• Far greater expectation from patients to connect directly on their experiences

4. © MyMeds&Me 2015
What does the evolving PV landscape look like?
What are the challenges we face?
External forces
• Growing consumer awareness & advocacy
• Increasing Regulatory focus on risk management
• Increasing inspection scrutiny on non core areas
• Affiliate practices
• Patient Support Programs
• Sales Rep activities
Internal forces
• Aggressive annual growth of cases reported
• Cost containment pressure
• Varied portfolios with differing demands
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5. Addressing the challenges

6. © MyMeds&Me 2015
Quality: What form does it take and how does it
change across product portfolios?
New products
Need fast feedback as complete as possible to fuel
analytics for informed decisions in a timely & consistent
manner.
Established products
High data volumes that need to be processed in a compliant,
automated manner with an emphasis on product quality.
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7. © MyMeds&Me 2015
Moving from passive to active pharmacovigilance
Current activities
• Passive
• Rigid
• Manual
Future state
• Active
• Decision
oriented
• Automated /
Intelligent

8. © MyMeds&Me 2015
What does innovation mean in Pharmacovigilance?
Technology?
Process
improvement?

9. © MyMeds&Me 2015
Meeting your risk management commitments
1. How can we ensure that the relevant information is
requested at the initial adverse event report particularly
for Events of Special Interest (ESI)?
2. How do we route safety information rapidly to a medical
reviewer and document actions taken?
3. How do we alert other stakeholders of SAE or ESI in the
case of post-approval study etc.?

10. © MyMeds&Me 2015
How does intelligent intake technology ensure risk
management commitments are met?
Direct Reporting
Spontaneous AER
Patient Support
Programs
Indirect Reporting
Via Companies
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Dynamic workflow triggered by
product & event specific information

11. © MyMeds&Me 2015
Modular Architecture Overview
Core Interface Intelligent Triage
Algorithms
Journey Configurations
Reportum® Case Repository
ApplicationLayer
Product Lists
Label Data
MedDRA
Custom MedDRA
DataLibrariesDatabase
Metrics and Reporting
Medical
Data Submission
Standard
Triggers
Client Custom
Libraries
Standard Reportum®
Libraries
Call Centres
Direct Entry
Sales Reps
(mobile)
Clinical Trials
Patient Support

12. © MyMeds&Me 2015
Intuitive, intelligent intake technology at its best
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13. © MyMeds&Me 2015
Intuitive, intelligent intake technology at its best
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14. © MyMeds&Me 2015
Intuitive, intelligent intake technology at its best
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15. © MyMeds&Me 2015
Intelligent intake technology
Implementation benefits
• Ahighly scalable model that will evolve effectively with organisational
or environmental changes
• Asystem to ensure that only the required information is captured for
the products in question
• Amechanism to reduce costs

16. © MyMeds&Me 2015
Conclusion
A focus on intake and intelligent triage enables improved
downstream signal detection and risk management.

17. Learn more at:
www.mymedsandme.com
Follow us on:
@mymedsandme MyMeds&Me
Contact us at:
info@mymedsandme.com
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