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Monday, June 28 • 1:00pm - 2:00pm
#118 SL: Advanced Analytics, Cross-Industry Collaboration, and Data Sharing to Change the Paradigm in Clinical Quality

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-529-L04-P; CME 1.00; IACET 1.00; RN 1.00

In this session, we will share selected use cases on our collaboration framework. We will also engage with the audience on how we (industry, regulators, patients) can all contribute to a change in paradigm for QA, i.e. where advanced analytics can help detecting and mitigating issues faster, and ultimately accelerate approval and patient access of innovative drugs.

Learning Objectives

Examine how advanced analytics are utilized throughout the development lifecycle and how this could lead to a paradigm shift in clinical quality; Describe how the inter company quality analytics (IMPALA) group members collaborate to accelerate the development of advanced analytics for clinical quality; Identify how cross-company data sharing can foster development and validation of advanced analytics.

Chair

Timothe Claude Menard, PharmD, MSc

Speaker

Industry Update
Jennifer Emerson, PhD, MPH, RN, PMP

Industry Update
David Donohue, MBA

Industry Update
Robert Studt


Speakers
avatar for Robert Studt

Robert Studt

Head of Quality Analytics, BioResearch Quality and Compliance, Janssen, United States
Rob is currently the head of Quality Analytics in Johnson & Johnson's BioResearch Quality & Compliance. He began his career as a drug discovery chemist, and has worked in leadership roles in Drug Discovery, R&D IT, and Quality & Compliance. Current interests are in applications of... Read More →
DD

David Donohue

Head, Quality Systems and Data Analytics, GlaxoSmithKline, United States
David Donohue leads Quality Systems and Data Analytics, Global Quality Assurance He is accountable for defining and delivering the data analytics program to proactively identify trends, emerging issues and shared learnings for Pharma R&D.
avatar for Timothe Menard

Timothe Menard

Global Head, Quality Excellence Digital | Bioethics Coach (Data Ethics), F. Hoffmann-La Roche Ltd, Switzerland
Started in drug safety at Merck KGaA, joined Roche as a GCP/PV auditor. Transitioned to analytics; now heads Quality Excellence Digital. Focuses on digital & analytics for core quality deliverables. Co-founded the Inter coMPany quALity Analytics consortium to drive data/quality policy... Read More →
avatar for Jennifer Emerson

Jennifer Emerson

Head Quality Analytics & Risk Management, Boehringer Ingelheim, Germany
Clinical research professional with more than 20 years' experience in Quality Management, Project Management, Monitoring & Pharmacovigilance. PhD in Public Health - Epidemiology, Project Management Professional (PMP) Certified, ISO 9001:2015 certified Auditor. Current role: Head of... Read More →

Monday June 28, 2021 1:00pm - 2:00pm EDT
TBD Virtual Event Horsham, PA 19044
  08: RD Quality-Compliance, Session |   03: Data-Data Standards, Session