1. CONFIGURATION
Pharmacovigilance
navigating
The path to building and monitoring the
safety profile of pharmaceutical products and
devices can be complicated. Ashfield
Pharmacovigilance ensures a smooth journey
allowing you to focus your expertise on other
crucial areas of product development.
PV REGULATORY CHANGES (2012-2015)
• EMA GVP Legislative Changes – GVP Modules Replacing
Volume 9A and 10
• EU Pharmaceutical System Master File Requirement (PSMF)
• Periodic Benefit Risk Evaluation Report (PBRER)
Implementation
• FDA PV Reporting Requirements from Social Media Sources
• FDA Clinical PV Regulatory Changes
• ICH Electronic Format Reporting Changes
• EU Local QPPV Requirements
• Risk Based Inspection Programs FDA & MHRA
• Cosmetovigilance PV Requirements
COMPLIANCE & REGULATORY SOLUTIONS
DATABASE & IT SERVICES
AUDIT SUPPORT &
STRATEGY REVIEW
PROACTIVE RISK
MITIGATION
CRISIS
MANAGEMENT
SOLUTIONS
!
SOFTWARE
LICENSES
IT INFRASTRUCTURE
ASHFIELD PHARMACOVIGILANCE EMPLOYEES ARE
TENURED LIFE SCIENCE OR HEALTHCARE
PROFESSIONALS
GREATER THAN
IMPLEMENTATION
SDLC
VALIDATION
HUMAN & ANIMAL HEALTH
in a wide range of therapeutic areas
COSMETICS
MEDICAL DEVICE
HOMEOPATHIC PRODUCTS
DIETARY SUPPLEMENTS
RX
OVER THE COUNTER
CONSUMER PRODUCTS
INTERNATIONAL EXPERIENCEINTERNATIONAL EXPERIENCE
SUPPORTED CLIENT DIRECTED PV INSPECTIONS BY
11 DIFFERENT GLOBAL REGULATORY AGENCIES
ASHFIELD PHARMACOVIGILANCE:
EXPERTS IN COMPLIANCE,
REGULATION, AND IMPLEMENTATION
CONFIGURATION & SYSTEM COMPLEXITY
• Changes configured and implemented in a
timely manner to meet government requirements
13 YEARS HOSTING PV DATABASES
• Integration yields more ownership of results
• Gold Partner of Oracle
• Experience with SDLCs from implementation
to long-term updates
DISASTER RECOVERY & BUSINESS CONTINUITY
• Argus Safety 7 Platform
- Tier 3 Data Center – SSAE16 Certified Facility
- Fully virtualized environment for enhanced
Disaster Recovery
SAFETY EXPERIENCE & EXPERTISESAFETY EXPERIENCE & EXPERTISE
REGULATORY INTELLIGENCE SUPPORT
• Routinely monitoring the regulatory and
compliance landscape
STAFFING & VALIDATION
IT & Database Hosting Services
Call Center Management
Risk Management Activities
Literature Search Services
Signal Detection and Management
Audit / Inspection Readiness & Support
Global Aggregate Reporting
Regulatory Reporting
Comprehensive Case Management
QUALITY
Only the best is
good enough.
PARTNERSHIP
Building trust. Delivering
on promises.
INGENUITY
A commitment to
problem resolution &
resourceful thinking.
EXPERTISE
Time-tested knowledge
and experience.
ENERGY
A passion for
pharmacovigilance.
• The FDA has inspected our
operations in 2005, 2011, and
2013 with no FD483 findings
• 12 on-site client audits per year
• Provides regulatory audit &
inspection support over 10
times per year for our
clients
MEDICAL DEVICE:
14,339 cases
annually
CONSUMER & OTC:
54,385 cases
annually
RX (POSTMARKETING, CLINICAL &
LITERATURE): 3,838 cases annually
ANIMAL HEALTH:
45,000 cases
annually
RX
AnimalHealth
Consumer&OTC
MedDevice
CASE MANAGEMENT WITH ASHFIELD PHARMACOVIGILANCE
TECHNOLOGY EXPERIENCETECHNOLOGY EXPERIENCE
IMPLEMENTING THE RIGHT SOLUTIONIMPLEMENTING THE RIGHT SOLUTION
FULL-SERVICE & TAILORED SOLUTIONS
THE ASHFIELD PHARMACOVIGILANCE DIFFERENCE
30% INCREASE IN DEVICE RECALLS
127% IN MEDICINAL PRODUCT RECALLS
REGULATORY UNCERTAINTY
Tested SuccessA TYPICAL YEAR BY THE NUMBERS