Menu
VIPGroup

Lean, Six Sigma Consulting

Lean Enterprise | Lean Manufacturing | Lean Supply Chain | Lean Regulatory Compliance
  • Home
  • Services
    • Lean System for Management
    • Lean Retail
    • Lean Enterprise
    • Lean For Manufacturing
    • Digital Factory
    • Lean Supply Chain
    • Six Sigma
    • Regulatory & Compliance
    • Lean Healthcare
    • Pharmacovigilance
  • Expertise
    • VIP Lean Manufacturing Key Elements
    • Pharmacovigilance Approach
    • Lean And Six Sigma Approach
    • Lean Consultants
    • Contact VIPGroup
  • Articles
    • Leading in New Ways
    • The Isolated Executive
    • Where Leaders Prevail and Managers Fail
    • Quality Part 1
      • Quality Part 2
    • Supply Chain
    • Maintenance Versus Production
    • Project Management
      • Project Management Page 2
    • Lean Transformation
      • Employee Engagement
    • Lean Enterprise
      • Lean Enterprise Part 2
    • Lean Performance Measurement Systems
      • Lean Performance Measurement Systems Part 2
    • Lean Pharmacovigilance
      • Compliant Operations
    • Lean Leadership
  • Training & Workshops
    • Lean Six Sigma Training
    • Training Events US & China
  • Our Clients
    • Client Testimonials
  • Case Studies
  • About
    • Our Code of Ethics
  • Contact
    • Employment Opportunites
  • Home
  • Services
    • Lean System for Management
    • Lean Retail
    • Lean Enterprise
    • Lean For Manufacturing
    • Digital Factory
    • Lean Supply Chain
    • Six Sigma
    • Regulatory & Compliance
    • Lean Healthcare
    • Pharmacovigilance
  • Expertise
    • VIP Lean Manufacturing Key Elements
    • Pharmacovigilance Approach
    • Lean And Six Sigma Approach
    • Lean Consultants
    • Contact VIPGroup
  • Articles
    • Leading in New Ways
    • The Isolated Executive
    • Where Leaders Prevail and Managers Fail
    • Quality Part 1
      • Quality Part 2
    • Supply Chain
    • Maintenance Versus Production
    • Project Management
      • Project Management Page 2
    • Lean Transformation
      • Employee Engagement
    • Lean Enterprise
      • Lean Enterprise Part 2
    • Lean Performance Measurement Systems
      • Lean Performance Measurement Systems Part 2
    • Lean Pharmacovigilance
      • Compliant Operations
    • Lean Leadership
  • Training & Workshops
    • Lean Six Sigma Training
    • Training Events US & China
  • Our Clients
    • Client Testimonials
  • Case Studies
  • About
    • Our Code of Ethics
  • Contact
    • Employment Opportunites

​Pharmacovigilance

Pharmacovigilance Methodology

An ongoing assessment of the benefit-risk profile of products based on the collection and collation of reports of adverse events, from whatever the source.

Adverse Event (AE)

Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a casual relationship with its treatment. An AE can therefore be any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.

Serious Adverse Event (SAE)

Any untoward medicinal occurrence that at any dose:  
  • Results in death
  • Is life threatening
  • Requires hospitalization
  • or prolongation of existing hospitalization
  • Results in persistent or significant disability, incapacity 

Pharmacovigilance ​Process Flow

  • Collect and collate AE reports from clinical trials
  • Collect and collate Spontaneous AE reports from consumers and health professionals
  • Collect and collate AE reports from literature sources and regulatory authorities
  • Assess the seriousness and expectations of the reports
  • Enter the data into a suitable central databaseProvide a medical evaluation of the report
  • Provide an analysis of similar events for expedited reports
  • Ensure that reporting timelines for expedited reports are met

Adverse Events Include

  • Exacerbation of a preexisting illness
  • Increased frequency or severity of a pre-existing condition
  • Condition diagnosed after study drug initiated
  • Continuous or persistent symptom or disease present at baseline which worsens

FDA Reporting Requirements

  • Serious: 15-day written IND Safety Report: Unexpected - Drug related
  • Serious-Fatal: 7-day Phone or Fax Report: Unexpected-Drug related-Life threatening or Fatal

Lean Principles for Case Handling

Lean Process Case Handling Pharmacovigilance Methodology

Process

​Efficient & Streamlined
Simple & Visible
Harmonized Across Departments
Right First Time Approach
Agreed Business Rules

Standards

​Consistent
Simple & Readable
Understood by All

External

​Compliance
Quality Assessments
Gain Regulators Confidence

Pharmacovigilance

​Proactive
Active Communications
Best Methods Used
Involvement of All Units
Signals Detected & Evaluated 

Systems

​One Global Database
Transparent Tracking
Reduction of Duplication

People

​Correct Number
Training on the Process
Orientation in Lean 

Organizational Structure

​Process Aligned
Aligned Priorities, Roles and Responsibilities
Communication, Co-operation, Co-ordination and Empowerment

Performance Measurement

​Focused on Thoroughness, Integrity, Timely
Simple and Visible 
Aligned Targets, Rewords and Recognition

Chicago​

1537 Hazelnut Crossing
Mundelein, IL 60060
​USA

 847-566-7740

plucansky@vipgroup.us

Europe

12 Monti Di Villa
Riolo
Lucca, Italy

001 847-566-7740

plucansky@vipgroup.us

Boston

14 Willowdale Dr
Merrimac, MA 01860
USA

617-803-1325

rburke@vipgroup.us 

Singapore

28 Simei Street 1
#01-13 Singapore
​Republic of Singapore

001 847-566-7740

plucansky@vipgroup.us

Ready to Talk?

For information about how the VIPGroup can assist your program call 847.566.7740 or Contact Us directly.
Picture
Picture
Picture
Picture
© Value Innovation Partners LTD. 2017 All Rights Reserved