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CONFIGURATION
Pharmacovigilance
navigating
The path to building and monitoring the
safety profile of pharmaceutical produc...
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Ashfield Pharmacovigilance

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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

Published in: Healthcare
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Ashfield Pharmacovigilance

  1. 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

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