CONFIGURATION

Pharmacovigilancenav igating

The path to building and monitoring the safety profile of pharmaceutical products and devices can be complicated. DSA 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 & REGULATION SOLUTIONS

DATABASE & IT SERVICES

AUDIT SUPPORT &

STRATEGY REVIEW

PROACTIVE RISK

MITIGATION

CRISIS

MANAGEMENT

SOLUTIONS

!

SOFTWARE

LICENSES

IT INFRASTRUCTURE

DSA 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

DSA: 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

Small: $500k – $1.3MMid-Large: $1.5M - $10M+

TRAININGSystem Administrator Training (6-12months)

COMPLIANCEAnnual MedDRA & WHODrug updates

STAFFINGIT Professionals

COSTS

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 DSA’s 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 annuallyRX

Animal Health

Consumer & OTC

Med Device

CASE MANAGEMENT WITH DSACASE MANAGEMENT WITH DSA

TECHNOLOGY EXPERIENCETECHNOLOGY EXPERIENCE

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

THE DSA DIFFERENCE

30% INCREASE IN DEVICE RECALLS

30% INCREASE IN DEVICE RECALLS

127% IN MEDICINAL PRODUCT RECALLS

REGULATORY UNCERTAINTY

Tested SuccessA TYPICAL YEAR BY THE NUMBERS