Event Archives

Event Name Event Description Event Dates Event Location

SCOPE Summit Europe & Clinical Trial Innovation Summit 2020 Virtual Event

INTERACTIVE BREAKOUT DISCUSSION GROUPS
Date: November 10, 2020

Breakout 7: Implementation of Clinical Development Risk Management
Moderators:
Linda Sullivan, Executive Director, WCG-Metrics Champion Consortium LLC
Jonathan Rowe, PhD, Associate Principal, ZS Associates
Keith Dorricott, Ambassador, Metrics Champion Consortium
Dagmar Goertz, Director, External Engagement & Business Insights, BioResearch Quality & Compliance, Janssen

  • Is RBM delivering?
  • What is the role of proactively establishing QTLs
  • Any good predictive models?

 

TRACK: ICH E8 REGULATORY GUIDELINES AND RBQM STRATEGY
Date: November 11, 2020

Presentation: How Can Cost of Quality Help Us Implement Quality by Design (ICH E8 R1)?
Keith Dorricott, Ambassador, Metrics Champion Consortium

Panel: Overcoming Challenges of Advancing Risk Based Monitoring and Quality by Design
Panel Moderator: Asmaa Mrabti, Study Risks and RBM Expert, Trial Operations, Sanofi
Panelists:
Keith Dorricott, Ambassador, Metrics Champion Consortium
Marion Wolfs, Head, Senior Director, Risk Management & Central Monitoring, Janssen Pharmaceutical Companies of Johnson & Johnson

 

TRACK: RISK MANAGEMENT AND VENDOR OVERSIGHT: METRICS AND KPIS
Date: November 11, 2020

Presentation: Critical Data and Processes: How ICHE6(R2) Is Changing Vendor Management and the Data Sponsors Are Reviewing during Clinical Studies
Linda Sullivan, MBA, Executive Director, WCG-Metrics Champion Consortium
 
Panel: Risk Management and Vendor Oversight: Metrics and KPIs
Panel Moderator: Andy Lawton, Director & Consultant, Risk Based Approach Ltd.
Panelists:
Marina Malikova, PhD, Executive Director, Surgical Translational Research: Operations and Compliance, Boston University School of Medicine
Linda Sullivan, MBA, Executive Director, WCG-Metrics Champion Consortium

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11/10/2020-11/11/2020

Virtual

MCC Clinical Trial Risk and Performance Management Summit

Date:  September 8 – 10, 2020

Location:  Virtual

Please contact MCC Co-Founder and Executive Director Linda Sullivan or MCC Ambassador Keith Dorricott if there are topics you would like to see included for the 2020 Summit and if you are interested in participating as a presenter or panelist.

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07/08/2020-09/10/2020

Philadelphia, PA

DIA 2020 Global Annual Meeting

Session: How Do You Oversee and Manage New Centralized/Remote/Site Monitoring Models? What Should You Measure to Gain Insights? 

Session Date: Monday, June 15, 2020
Time: 1:30 – 2:30 pm EDT

Session Moderator:
Linda B Sullivan, MBA
Executive Director
WCG MCC

Panelists:
Jacqueline Gough, MS
Director, Central Monitoring and Data Surveillance
Astellas, United States

Joe Kunakorn, MS
Associate Director, Oncology Risk Management for CAR-T and Apulutamide
Janssen Research & Development, LLC, United States

Charles Lawrence Liss, MS
Associate Director, Global Biostatistics
CSL Behring, United States

Barbara Novak
Systems and Process Management Lead, Clinical Operations- NA/EU
Kyowa Kirin Pharmaceutical Development, Inc., United States

 

For additional information, please visit https://www.diaglobal.org/Flagship/DIA-2020

06/15/2020-06/15/2020

Clinical Trial Innovation Summit

Date:  April 6 – 8, 2020

Location:  Cambridge, MA

Track: Risk-based Monitoring

Presentation:  Is Your Centralized/Onsite Site Monitoring Program Being Implemented per ICH E6(R2)? How Do You Know?

Linda Sullivan, Co-Founder & Executive Director, WCG-Metrics Champion Consortium

 

Roundtable Discussion: Implementation of Clinical Development Risk Management

Linda Sullivan, Co-Founder & Executive Director, WCG-Metrics Champion Consortium

Jonathan Rowe, Pfizer

  • Is RBM delivering?
  • What is the role of proactively establishing QTLs
  • Any good predictive models?

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04/06/2020-04/08/2020

Cambridge, MA

SCOPE

Track:  Implementing Risk-Based Monitoring – Part 1

Date:  February 19, 2020

Location:  Orlando, FL

Risk-based Quality Management Strategy

10:40 – 10:45 am Chairperson’s Remarks

Linda Sullivan, Co-Founder & Executive Director, WCG-Metrics Champion Consortium

 

11:10 -11:35 am Co-Presentation:  Bridging the Gap between Issue Management and Risk-based Quality Management

Linda Sullivan, Co-Founder & Executive Director, WCG-Metrics Champion Consortium

Ann McCabe, Director, Process Excellence & Risk Management, Daiichi Sankyo, Inc.

 

2020 Interactive Breakout Discussions

OUTSOURCING, STRATEGIC PARTNERSHIPS, AND KPIS

Date:  February 19, 2020 from 4:20 – 5:10 pm

Table 22:  Vendor Performance Metrics and KPIs

  • How effective are your KPIs for measuring vendor performance and quality?
  • What is your stategy for establishing KPIs and metrics?
  • What are the key areas that should be evaluated for vendor performance and quality?

Moderators:  Keith Dorricott, Ambassador, Metrics Champion Consortium; Director, DMPI Ltd.
Caro Unger, Senior Clinical Operations Standards and Innovation Manager, Clovis Oncology

 

Track: Managing Outsourced Clinical Trials

Date: February 21, 2020

Vendor Oversight: Metrics, KPIs and ICH E6 R2

8:25 – 8:55 am Presentation:  Defining Metrics for Quality Vendor Oversight

Keith Dorricott, Ambassador, WCG-Metrics Champion Consortium

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02/18/2020-02/21/2020

Orlando, FL

The Drug Development Workforce in the Age of Digital Transformation

Date:  December 4, 2019 from 9:30am – 3:30pm

Location:  Pfizer, New York, NY

Panelist:  Linda Sullivan, Co-Founder & Executive Director, WCG-Metrics Champion Consortium

12/04/2019-12/04/2019

Pfizer - NewYork, NY

Clinical Trials Europe

Date: November 21, 2019
Location: Barcelona, Spain

Session Title: “The Impact of Risk-based Quality Management on Vendor Oversight”

Session Participant: Keith Dorricott, Contractor for Metrics Champion Consortium (MCC)

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11/21/2019-11/21/2019

Barcelona, Spain

MAGI’s Clinical Research Conference – 2019 West

Date:   October 27, 2019
Location:  Las Vegas, Nevada

Session Title:  Sponsors of Choice/Sites of Choice: Measuring What Matters

Session Information:

In this working group, we will employ a structured process for defining the key attributes, metrics and performance levels that make a sponsor or site a great partner. This working group is open to people who want to participate, not just observe.

  • Cerdi Beltre – Senior Vice President, Strategic Site Services – WCG
  • Linda Sullivan, MBA – Co-founder and Executive Director, Metrics Champion Consortium

 

Session Title:  Site, Sponsor and CRO Metrics and Benchmarking

Session Information:

Measure the performance of your partners and your own organization.

  • Bishoy Anastasi, MPH MBA CCRP – Director, Clinical Research Finance – University of California, Los Angeles
  • Cindy Carter – President – CenterWatch
  • Michael Farley, BS MBA PMP – Associate Director, Quality and Compliance – Alexion USA
  • Linda Sullivan, MBA – Co-Founder and Executive Director, Metrics Champion Consortium

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10/27/2019-10/27/2019

Las Vegas, Nevada

Risky Business Forum

Date: September 20, 2019
Location: Gilead Sciences, Uxbridge, UK

Session Title: “Risk Evaluation and Control – Meeting the Requirements of ICH E6 (R2) A worked example with Keith Dorricott, Metrics Champion Consortium Ambassador”

Session Participant: Keith Dorricott, Contractor for Metrics Champion Consortium (MCC)

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09/20/2019-09/20/2019

Uxbridge, UK

Workshop: Building Capacity for Patient-Centered R&D

Date:  September 16, 2019
Location:  Milken Institute School of Public Health at George Washington University, Washington D.C.

Session Title: Measuring Success—What does it look like?

Session Information:

Moderator: Roslyn Schneider

Session objective: Discuss how we can measure outcomes and effectiveness of patient capacity-building efforts and identify what aspects of capacity-building programs contribute to achieving success (e.g., clear focus on target audience, purpose/desired outcomes, method for deploying training, cost/sustainability, multi-stakeholder participation).

  • Matthew May, Programme Coordinator, EUPATI
  • Linda Sullivan, Co-founder and Executive Director, Metrics Champion Consortium

09/16/2019-09/16/2019

Washington D.C.

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