CONFIGURATION

Pharmacovigilancenav igating

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 EXPERIENCESUPPORTED 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 implementationto 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

QUALITYOnly the best is good enough.

PARTNERSHIPBuilding trust. Delivering

on promises.

INGENUITYA commitment to

problem resolution & resourceful thinking.

EXPERTISETime-tested knowledge

and experience.

ENERGYA passion for

pharmacovigilance.

• The FDA has inspected ouroperations in 2005, 2011, and2013 with no FD483 findings

• 12 on-site client audits per year

• Provides regulatory audit &inspection support over 10times per year for ourclients

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

Animal Health

Consumer & OTC

Med Device

CASE MANAGEMENT WITH ASHFIELD PHARMACOVIGILANCE

TECHNOLOGY EXPERIENCETECHNOLOGY EXPERIENCE

IMPLEMENTING THE RIGHT SOLUTIONIMPLEMENTING THE RIGHT SOLUTIONFULL-SERVICE & TAILORED SOLUTIONS

THE ASHFIELD PHARMACOVIGILANCE DIFFERENCE

30% INCREASE IN DEVICE RECALLS

30% INCREASEIN DEVICE RECALLS

127% IN MEDICINAL PRODUCT RECALLS

REGULATORY UNCERTAINTY

Tested SuccessA TYPICAL YEAR BY THE NUMBERS