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Tuesday, June 29 • 4:00pm - 5:00pm
#261 SL: Innovative Approaches to Trial Execution, Quality, and Compliance

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-592-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will provide insight from both regulatory and industry speakers on approaches to improve quality and compliance in clinical trials. Speakers will discuss: 1. Use of inspectional findings, quality data, and continuous improvement techniques to inform ongoing development of effective GxP quality systems. 2. How the COVID-19 pandemic has created opportunities to innovate and highlighted the need for quality analytics to revolutionize risk management systems, analytic auditing, and clinical trial oversight. 3. Importance of understanding unique trial design issues and emerging digital technologies to successfully execute decentralized clinical trials.

Learning Objectives

Describe regulatory perspectives on effective GxP quality systems; Identify how the COVID-19 Pandemic has accelerated innovation and spurred firms to revolutionize risk management systems and use new technologies to improve quality and compliance in clinical trials; Discuss how new digital technologies and proactive stakeholder engagement in trial design discussions enhance the probability of success for decentralized clinical trials.

Chair

Jean M. Mulinde, MD

Speaker

Using Quality Issues to your Advantage: A Regulator Perspective
Stephen Vinter

R&D Quality: Enabling the Post COVID-19 Continuum of Clinical Trial Innovation Through Fit-for-Purpose, Data-Driven Quality
Federico Feldstein, JD

Successful Decentralized Trials: More Than Just Moving Online
Dawn Anderson, BSN


Speakers
avatar for Jean Mulinde

Jean Mulinde

Medical Officer, Policy Advisor, Division of Clinical Compliance Evaluation, OSI, FDA, United States
Dr. Mulinde is currently the Senior Policy Advisor, Division of Clinical Compliance Evaluation in the Office of Scientific Investigations, CDER, FDA. Prior to joining the Office of Scientific Investigations, she was a Clinical Team Leader in the Division of Anti-Infective Products... Read More →
avatar for Federico Feldstein

Federico Feldstein

Vice President, Global Head of R&D Quality Compliance, Johnson & Johnson, United States
Federico Feldstein is Vice President, Head of R&D Quality & Compliance at Johnson & Johnson. Over the past 6 years, Federico has led the J&J R&D quality strategy leveraging the organizations’ strengths across the sectors (Medical Devices, Consumer, Pharmaceuticals) to enhance the... Read More →
avatar for Dawn Anderson

Dawn Anderson

Managing Director, Life Sciences, Deloitte, United States
Dawn is a Managing Director in Deloitte’s Life Sciences practice, and a leader in Deloitte’s Clinical Transformation practice. She has more than 30 years of industry experience in Global Pharma and CROs across Clinical Development & Operations with an emphasis on enabling her... Read More →
avatar for Stephen Vinter

Stephen Vinter

Operations Manager GLPMA and Laboratories Group, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Stephen Vinter is Operations Manager for the GLPMA and Laboratories Group for the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Prior to joining the Agency in 2012, Stephen worked in Operations Management at a Contract Research Organisation. Stephen has also... Read More →

Tuesday June 29, 2021 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
  08: RD Quality-Compliance, Session