Zoom Workshop
DEFINE CLINICAL RISKS AND TOLERANCE THRESHOLDS
Identify Risks Related to Critical Processes and Data and Define Tolerance Limits

Jonathan Rowe, Former Executive Director, Head of Clinical Development Quality Performance and Risk Management, PFIZER; aka The Clinical Risk Dude or The Big GCP Lebowski

Sheri Kuss, Director, Clinical Quality Lead, PFIZER


During this interactive Zoom workshop you’ll learn from and engage with your peers as you work in small groups to develop quality tolerance limits from a mock protocol. Learning objectives include:

  • Reinforcement of Quality Management guidelines
  • Understand the elements of a protocol’s processes and data that are critical to ensure human subject protection and the reliability of trial results
  • Identifying risks and what that means from a system and trial perspective
  • Evaluating risks relate to critical process and data
  • Reviewing Quality Tolerance Limits requirements and methodologies
  • Identifying and implementing Quality Tolerance Limits (QTLs) and establishing oversight during the trial
  • Modeling the components of GCP risk into an end-to-end approach
  • Learning real examples of QTL implementation during the pandemic

Registration Cost $199

Featured Speakers

Jonathan Rowe

Former Executive Director, Head of Clinical Development Quality Performance and Risk Management, PFIZER; aka The Clinical Risk Dude or The Big GCP Lebowski

Jonathan Rowe has 25 years of experience supporting pharmaceutical companies in the development of medical therapies from the clinical, operational and business perspectives. Currently, Jonathan holds the position of Head of R&D Quality and Risk Management at ZS Associates. From 2014-2019 Jonathan was the Head of Clinical Development Quality Performance and Risk Management at Pfizer, where his responsibilities included monitoring, modeling and predicting the Pfizer GCP Quality Management System, leading the analysis of Pfizer’s Clinical Trial Quality Performance and ensuring clinical trial quality risk management is built into all trials. At Pfizer he has held a number of roles including Clinical Director, with responsibility for the Phase IIIb and IV Lipitor program; Director, Intellectual Property Strategy Management; and Senior Director of Process and Performance. Jonathan spent a number of years in “small pharma” as the Head of Intellectual Property and Portfolio Strategy for both Amarin and Dignity Sciences. Jonathan earned his Ph.D. and M.S. at the Albert Einstein College of Medicine and his M.A. from Binghamton University.

Sheri Kuss

Director, Clinical Quality Lead, PFIZER

Sheri Kuss has more than 25 years of clinical research experience, with 17 of them being in a quality role. She is currently a Director, Clinical Quality Lead at Pfizer supporting the Covid Vaccine study.

Date:  Wednesday, January 27
Time:  1:00 PM ET – 3:00 PM ET

Registration is Now Closed
For questions, please email [email protected]