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Wednesday, June 29 • 4:00pm - 5:15pm
#359: Addressing Dysfunction in Provider Prequalification: A New Model to Streamline Processes, Improve Quality, and Reduce Risk

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Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

This forum will present data on industry challenges related to prequalification of technical service providers. Industry leading initiatives to standardize requirements and processes, and regulatory, sponsor and provider perspectives will be shared.

Learning Objectives

Identify risks, challenges, issues and industry dysfunction related to prequalifying technical service providers; Describe new industry standards/processes/approaches for prequalification of technical providers; Explain sponsor/provider/regulator perspectives regarding implications for standardizing and centralizing prequalification to ensure high quality, efficiency and confidence in processes and results.

Chair

Dawn M Niccum, BSN, MS, RN, PMP

Speaker

Panelist
Marta Haley Fields, MBA

Panelist
Mitchell A. Katz, PhD

Panelist
Dennis Salotti, MBA, MS

Panelist
Sean Y. Kassim, PhD



Chair
avatar for Dawn Niccum

Dawn Niccum

Associate Director, Quality, Endocyte
Dawn Niccum is the associate director of quality at Endocyte, where she is responsible for GCP compliance, SOP development, computer system validation oversight, and training. With over 20 years of pharmaceutical experience, Ms. Niccum holds a Master’s Degree in Regulatory Affairs... Read More →

Speakers
avatar for Marta Fields

Marta Fields

Senior Director, Research & Development Quality, Seattle Genetics, Inc.
Marta joined Seattle Genetics in 2008 as Sr Director of Compliance and Quality Systems after 21 years at Amgen where she served as Director of Clinical Compliance. Ms Fields has a BS in Speech from Northwestern University and an MBA in Healthcare Management from California Lutheran... Read More →
avatar for Sean Kassim

Sean Kassim

Director, Office of Study Integrity and Surveillance, OTS, CDER, FDA
Sean serves as the Director of the Office of Study Integrity and Surveillance, CDER/FDA. He oversees the bioavailability/bioequivalence (BA/BE) and GLP inspection programs that inspect and review conduct of regulated pharmaceutical premarket bioanalytical and non-clinical researc... Read More →
avatar for Mitchell Katz

Mitchell Katz

Head of Clinical Research and Drug Safety Operations, Purdue Pharma L.P.
Dr. Mitchell Katz is Head of Clinical Research and Drug Safety Operations at Purdue Pharma L.P. In this position, he is responsible for leading all operational activities across Purdue’s multinational clinical programs. Dr. Katz has 28 years’ experience in the pharmaceutical and... Read More →
avatar for Dennis Salotti

Dennis Salotti

Vice President, Operations, The Avoca Group
Dennis Salotti is Vice President of Operations at The Avoca Group and leads the strategy and execution of Avoca’s industry-leading research practice and Diligent™, the clinical research industry’s first centralized platform for clinical service provider prequalification. Mr... Read More →


Wednesday June 29, 2016 4:00pm - 5:15pm
111AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA