webinar: is your safety inbox a black hole?
DESCRIPTION
Webinar: Is Your Safety Inbox a Black Hole? Life science companies struggle to receive and manage product safety related information through their safety email inbox. The lack of audited tracking and the inability to control the entire intake process present risks to safety departments. Most often, safety email inboxes are described as "black holes" where all information comes in but is difficult to manage. This webinar showed you how November Research Group can solve your common pharmacovigilance challenges with a simple and effective solution. The purpose of this webinar is to empower you with more control over your case intake process. In this best practice-filled session, you will discover: - Common challenges pharmacovigilance departments face in the safety email inbox process - A systematic approach to better manage the intake and review of potentially reportable adverse events and complaints - An easy and efficient way to communicate with reporters through correspondence management - Industry best practices to prepare for intake process audits and inspectionsTRANSCRIPT
Is Your Safety Inbox a Black Hole?September 25, 2014
Presenter:Brad Gallien VP, Product DevelopmentNovember Research Group
2NOVEMBERRESEARCH GROUP Dedicated Leader in Pharmacovigilance Solutions
This document is proprietary to November Research Group. It is supplied in confidence and, except for evaluation purposes, cannot be disclosed, duplicated or otherwise used in whole or in part without the prior written consent of November Research Group.
The content of this document is subject to formal contract negotiations. Nothing in this document shall form the basis for any contract and nothing contained in this document will be binding against November Research Group unless expressly agreed to by November Research Group under a formal contract. All representations and warranties whether express or implied by statute, law or otherwise, are hereby excluded. This document was prepared on the instructions and information and accordingly no responsibility is accepted for any inaccuracy or error or any action taken or not taken in reliance on this document. This document makes reference to trademarks that may be owned by others. The use of such trademarks is not an assertion of ownership of such trademarks by November Research Group and is not intended to represent or imply the existence of an association between November Research Group and the lawful owners of such trademarks.
Safe Harbor
SummaryA quick look into the presentation
NOVEMBERRESEARCH GROUP Dedicated Leader in Pharmacovigilance Solutions
• About November Research Group• Collection of Adverse Events• Challenges• Business Impact• PRIMO Overview• Demo• Wrap-Up
4NOVEMBERRESEARCH GROUP Dedicated Leader in Pharmacovigilance Solutions
About November Research Group• November Research Group (NRG) provides global drug safety system
implementation services and software solutions for pharmaceutical and life science organizations– 70 consultants specializing in Oracle Argus, Oracle AERS, Empirica Trace– Experts in product safety regulations and pharmacovigilance systems– Global projects in the US, Europe and Japan– Dedicated Japanese practice area
• What we do?– Argus Safety implementation– Software tools such as PRIMO– AERS support– Complex data migration projects– EQMS, BPM projects– Custom reporting– Business Transformation
Who are our partners?
GoldPartne
rSpecializedOracle Argus Safety
5NOVEMBERRESEARCH GROUP Dedicated Leader in Pharmacovigilance Solutions
Our Capabilities
Services Software Evaluation
& Vendor Management
PV Process Optimization
Platform Upgrade/ Implementation
Migration Training Validation Support
Products PRIMO Platform
Family PRIMO
Manufacturer PRIMO Regulatory PRIMO MR iPRIMO Reporting Tool:
WebReports E2B Viewer
Incorporating lessons learned from previous projects
Strong knowledge of global requirements: U.S., EU & Japan
Experts in Argus implementations
PMP certified project managers
Risk based approach mitigating compliance risk
Successful track record for extending the capabilities of commercial-off-the-shelf (COTS)
safety systems
20+ years of product development experience in Life Sciences
Senior management experience in safety software development
Robust system development lifecycle
Maintenance includes enhancements & updates
English/Japanese speaking senior consultants drive project deliverables & communication transparency
Validation best practices compliant with CFR Part 11, EMA and PMDA regulations
6NOVEMBERRESEARCH GROUP Dedicated Leader in Pharmacovigilance Solutions
Collection of Adverse Events
Adverse events are collected from multiple sources including:• Spontaneous• Literature• Social Media• Partners• Sales representatives• Clinical Trials
Typically, adverse events are forwarded to a company’s Safety Group Inbox. This can lead to many challenges posing risks to the safety profile of products.
7NOVEMBERRESEARCH GROUP Dedicated Leader in Pharmacovigilance Solutions
Challenges
Lost Emails
Data QualityIssues
Manual Communication
Disconnected workflow
Limited Audit Controls
8NOVEMBERRESEARCH GROUP Dedicated Leader in Pharmacovigilance Solutions
How Does This Impact Your Business Process?
PV departments struggle with intake and find themselves
spinning their wheels to address challenges.
9NOVEMBERRESEARCH GROUP Dedicated Leader in Pharmacovigilance Solutions
PRIMO
High-Level Workflow – PRIMO Overlay
Sources
Intake Review
Triage
12
3
4
5
① Emails directly pulled and stored in PRIMO
② Automated letter generation and follow-up tracking
③ Full lifecycle of correspondence tracked
④ Report exchange with external systems
⑤ Fully audited and compliant process
All sources of potential AEs
Commercials systems such as Oracle Argus, ARISg, Sparta Trackwise or Pilgrim
PV/EQMS
10NOVEMBERRESEARCH GROUP Dedicated Leader in Pharmacovigilance Solutions
PRIMO BenefitsFeatures Benefits
Light-weight and easy to use Decrease data entry errors
Support all intake streams Instant metrics
Management of complete intake lifecycle Improved efficiency with a single intake solution
Correspondence Management Decrease follow-up response time
PV System integration Process ICSRs faster and boost your customers’ reporting timeliness
PRIMO is designed to make your intake process more transparent and more compliant
11NOVEMBERRESEARCH GROUP Dedicated Leader in Pharmacovigilance Solutions
Demo
• Demo slides are not available at SlideShare• If you want a demo, please contact [email protected]
12NOVEMBERRESEARCH GROUP Dedicated Leader in Pharmacovigilance Solutions
• Visit our website http://www.novemberresearch.com/
• Download PRIMO Datasheethttp://www.novemberresearch.com/files/PRIMODataSheetEnglish.pdf
• Brad Gallien – VP, Product [email protected](415)279-9107
• Seth Warhaftig – [email protected](415) 987-3313
Next Steps