This event has ended. Visit the official site or create your own event on Sched.

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

Sign up or log in to save this to your schedule and see who's attending!

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.


Dawn M Niccum, BSN, MS, RN, PMP


Marta Haley Fields, MBA

Mitchell A. Katz, PhD

Dennis Salotti, MBA, MS

Sean Y. Kassim, PhD

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 →

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

Chief Operating Officer, The Avoca Group
With over 18 years in the pharmaceutical industry as a sponsor, provider, and consultant, Dennis Salotti's experience spans preclinical research, clinical operations, data management, quality assurance, eClinical, business operations, and strategic management. Prior to Avoca, he was... Read More →

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