Ashfield Pharmacovigilance is a global leader in safety and risk management services supporting pharmaceutical, biotech, medical device, consumer health and animal health organizations. Uniquely focused on pharmacovigilance, we provide outsourced solutions and modified services to augment existing safety departments. Ashfield Pharmacovigilance has a unique advantage in drug safety and pharmacovigilance due to the high level of expertise across our case managers, project managers, quality and regulatory staff and database administrators. We allow you to focus on your core business, while we partner with you to promote patient safety and product longevity. We achieve this by fostering the open exchange of ideas among organizations throughout the pharmacovigilance community. By delivering innovative approaches to global case management, aggregate report development, literature search services, signal detection and surveillance, risk management services, safety system implementation, and medical information and call center services, Ashfield Pharmacovigilance is helping to advance the practice of pharmacovigilance on a global scale. Founded in 2000, we were acquired by UDG Healthcare in 2012 and are proud to be part of its Ashfield division. Ashfield Pharmacovigilance is headquartered in Research Triangle Park, North Carolina. Learn more about us at www.ashfieldhealthcare.com and follow us on Twitter, @DSA_PV and LinkedIn. About Ashfield Healthcare Ashfield Commercial & Medical Services is the sales, marketing and medical arm of UDG Healthcare plc. Established in the UK in 1997, the division is comprised of eight areas of expertise with a history of providing outstanding, client-focused services. These eight areas of expertise include medical information, pharmacovigilance, healthcare communications, contract sales, market research, leadership training, market access strategy and meeting and event planning. The division consists of more than 5,500 staff in 20 countries. About UDG Healthcare Headquartered in Dublin, Ireland, UDG Healthcare plc is a diverse, global healthcare solutions company with interests in healthcare supply chain management, special packaging, sales and marketing and medical services for life science companies. Find out more http://www.ashfieldhealthcare.com

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