SafetyCall International

© 2004 SafetyCall International PLLC. All rights reserved. All trademarks herein are property of SafetyCall, PLLC. All rights, title, and interest in and to all specifications, ideas and concepts contained herein shall at all times be and remain vested in SafetyCall. Any persons with access to this document shall not retain, use or disclose any of such work product without SafetyCall’s prior written consent.

SafetyCall International, PLLC

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Our mission is to provide our clients and their customers immediate access to clear and trusted health, safety, and medical information 24/7. As the market leader in adverse event management and post-market surveillance services, we actively enhance and promote product safety and facilitate complete and accurate regulatory reporting.

Mission Statement

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• Over 25 years of experience in Adverse Event Management and product safety

• World largest provider of Adverse Event Management services to Industry

• Nearly 2 million consumer/institutional product incidents managed

• Nationally recognized as authoritative and credible experts in the area of Adverse Event Management, post-market surveillance, and product stewardship

Our Professional Experience

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Three Core Services:• 24/7 Human and Animal Adverse Event Management• SafetyCall Consulting Group• 24/7 Pet Poison Helpline™

Services

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• Animal Health and Veterinary Products• Ag-Chem• Cosmetics and Beauty Aids• Food Products• Household Consumer Products • Industrial Chemicals • Institutional Products • Nutritional and Dietary Supplements• Pharmaceuticals (OTC and Rx)

Markets Served

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Formal affiliation with the University of Minnesota• Teaching• Service• Research• Policy Development• Advocates for Sound Science in Regulatory Decision Making

Academic & Scholarly Activities

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Entire senior management team comprised of experts with front line experience in patient care and direct client service

Executive Management

Leo Sioris, PharmDCEO & Sr. Clinical Toxicologist

Rick Kingston, PharmDPresident, Regulatory/Scientific Affairs &

Sr. Clinical Toxicologist

Dean Filandrinos, PharmDVP, Operations & Sr. Clinical Toxicologist

John Gualtieri, PharmD, CSPI, MT(ASCP)VP, Informations Systems and

Pharmacovigilance & Sr. Clinical Toxicologist

Lynn Hovda, BS, RPh, DVM, MS, ACVIMVeterinary Medical Director

Steve Borron, MD, MS, FACEP, FACMTMedical Director

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Case Management• A single source health care provider for managing both animal and human

allegations or reports of product related adverse events• Highly trained professional staff providing case management and advice 24/7

to consumers or their health care providers on behalf of our corporate clients• Front line toxicologists 24/7• On-Call back-up senior clinicians across all medical disciplines• Primary “Client Liaison” facilitating communications between our respective

organizations• High level case reviews

24/7 Adverse Event Management Service

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Regulatory Reporting• Provide timely and complete adverse event regulatory reports

involving EPA registered products, drugs regulated by the FDA, or products regulated under TSCA

• FIFRA 6(a)2 Single Incident Reports and Quarterly Aggregated Data

• PMRA Reporting

• Dietary Supplement FDA Reporting

24/7 Adverse Event Management Service

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• Regulatory compliance• Industry to government interface• Product risk assessment, management• Risk communication to your stakeholders including,

consumers, NGO’s, regulators, suppliers and legislators

SafetyCall Consulting

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A division of SafetyCall, Pet Poison Helpline (PPH) is an international, 24-hour service available to pet owners and veterinary professionals requiring assistance with a potentially poisoned pet.

Pet Poison Helpline™

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• We recently ranked #3 in the small business category by the Star Tribune as a Top Workplace in the Twin Cities metro.

• The Star Tribune’s Top Workplaces recognizes the most progressive companies in the Twin Cities metro based on employee opinions about company leadership, career opportunities, workplace flexibility, compensation and benefits.

SafetyCall International & Pet Poison Helpline™Awarded Top Workplaces 2010

© 2004 SafetyCall International PLLC. All rights reserved. All trademarks herein are property of SafetyCall, PLLC. All rights, title, and interest in and to all specifications, ideas and concepts contained herein shall at all times be and remain vested in SafetyCall. Any persons with access to this document shall not retain, use or disclose any of such work product without SafetyCall’s prior written consent.

SafetyCall International, PLLC

Please contact [email protected]

866-327-7282

www.safetycall.com