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#402: Quality Risk Management for a Decentralized/Hybrid Clinical Trial: A Role Play by Representatives of Key Stakeholders
Thursday June 19, 2025 9:00am - 10:00am EDT
145AB
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-669-L04-P; CME 1.00; RN 1.00

A cross-functional panel of experts will role-play a risk review meeting discussion to identify, assess, categorize, and prioritize risks of a mock protocol decentralized clinical trial (DCT) and outline potential mitigation activities.

Learning Objectives

Outline why risk identification is a fundamental consideration when planning a Decentralized/Hybrid Clinical trial; Define roles and responsibilities for key stakeholders to identify risks for Decentralized/Hybrid Clinical Trial; Identify who are the key stakeholders for a decentralized/Hybrid Clinical trial; Discuss developing fit-for-purpose Oversight Plans.

Chair

Paula Horowitz

Speaker

Panelist
Gina Lisette Williamson, BSN, MBA

Quality Risk Management for a Decentralized/Hybrid Clinical Trial: A Role Play by Representatives of Key Stakeholders
Maryrose Petrizzo, MS

Panelist
Terry Katz, MS


Speakers
avatar for Paula Horowitz

Paula Horowitz

Program Manager, QA, GCP Software Validation, AbbVie, United States
Paula Horowitz is a Quality, Project and Data Management professional with 25+ years experience in Biopharmaceutical, CRO and academic environments. Currently, at AbbVie, Ms. Horowitz is a Program Manager, Software Validation within the QA organization. She provides QA risk-based... Read More →
avatar for Terry Katz

Terry Katz

Senior Director, Biostatistics and DM Planning and Functional Excellence, Daiichi Sankyo, United States
Terry Katz is Sr Dir of Biostatistics and DM Planning and Functional Excellence at Daiichi Sankyo. Previously he was Head of Global Data Management and Statistics at Merck Animal Health, Head of Biometrics at ImClone Systems, Senior Manager of Analysis & Reporting for PRA, and a Statistician... Read More →
avatar for Maryrose Petrizzo

Maryrose Petrizzo

President and Consultant, Clinical Quality Assured,LLC, United States
Maryrose has over 25years of GCP experience in Clinical Quality Assurance and Quality Systems for the pharmaceutical, biologics and medical device industries including: site and process auditing, inspection readiness, due diligence, risk management, acquisition integrations, and clinical... Read More →
avatar for Gina Williamson

Gina Williamson

Associate Director Site solutions, Illingworth, A Syneos Health Company, Spain
A seasoned professional with over 19 years of experience in the Contract Research Organization (CRO) and pharmaceutical industry. Demonstrated expertise in leading and managing clinical trials, with hand on experience from both site and industry perspectives. Proficiency in overseeing... Read More →
Thursday June 19, 2025 9:00am - 10:00am EDT
145AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Forum
  • Level Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Tags Forum

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