Event Archives
| Event Name | Event Description | Event Dates | Event Location |
|---|---|---|---|
Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations (public workshop) | Date: July 17, 2019 – 8:30 am to 4:00 pm FDA is seeking feedback from stakeholders on the challenges, barriers, and enablers that might be impacting the adoption of RBM, and related opportunities to improve RBM implementation. This public workshop, held under a cooperative agreement with the U.S. Food and Drug Administration, is an opportunity to capture stakeholder input on:
Session 5: Measuring the Impact of Risk-Based Monitoring Approaches Session Participant: Linda B Sullivan, Executive Director WCG-Metrics Champion Consortium | 07/17/2019-07/17/2019 | Washington, DC |
DIA Annual Meeting | Date: Tuesday, June 25 • 10:30am – 11:30am Session Title: Retooling Risk Assessment to Align with ICH-E6(R2) and Connect to Centralized Monitoring and Risk-Based Monitoring Moderator: Linda B Sullivan, MBA Executive Director, Metrics Champion Consortium Panelists: Ann McCabe Sherry Merrifield | 06/25/2019-06/25/2019 | San Diego, CA |
European Clinical Trials Inspection Readiness Summit | Date: May 16–17, 2019 Session Title: Building the Gap Between CAPA and Quality Risk Management to Prevent Systemic-Level Issues Session Information:
Session Participation: Keith Dorricott, Ambassador, Metrics Champion Consortium | 05/16/2019-05/17/2019 | London, UK |
Clinical Trial Innovation Summit | Date: May 13–15, 2019 Session Title: Connecting CAPA Preventative Actions to Quality Risk Management to Reduce Systemic-Level Risks on New and Ongoing Studies Session Information:
Session Participation: Linda B Sullivan MBA Executive Director, Metrics Champion Consortium
Session Title: Using Site Contracting Performance Metrics in Site Selection—Do You Have Access to the Right Data to Understand How the Site Performed? Session Information:
Session Participation: Linda B Sullivan MBA Executive Director, Metrics Champion Consortium | 05/13/2019-05/15/2019 | Boston, MA |
Evolution Summit Spring 2019 (Invitation only event) | The Evolution Summit is the premium forum bringing leading drug development executives and solution providers together. As an invitation-only event, taking place behind closed doors, the Summit offers an intimate environment for a focused discussion of key new drivers shaping drug development. Date: February 24–26 2019 Session Title: The A-Z of Risk-Based Monitoring (RBM): Strategies for the Future Session Information: As the clinical trials industry continuously evolves, novel strategies must be implemented in an effort to operate efficiently and ultimately accelerate drugs to market. A more centralized, risk-based approach to site monitoring has presented itself as one viable method of reducing costs. Although RBM has been buzzing in the industry for quite some time, its adaptation has been slow. This presentation will shed light on:
Session Participation: Linda B. Sullivan, Executive Director, Metrics Champion Consortium | 02/24/2019-02/26/2019 | Rancho Mirage, CA |
SCOPE – Summit for Clinical Ops Executives 2019 | Date: Tuesday, February 19, 2019 (4:15–5:00 PM) Interactive Breakout Discussions:
Participation: Moderator – Linda B. Sullivan, Executive Director, Metrics Champion Consortium
Date: Wednesday, February 20, 2019 (8:55 AM) Track: Mastering an Outsourcing Strategy Panel Discussion: Ensuring Harmony between All Stakeholders – Sponsor, CRO, and Site – When Site Sourcing Topics to be discussed: Working with stakeholders on setting appropriate site budgets, site contracting, site identification, selection of sites, and site oversight/ management Moderator: Ly Kawaguchi, Senior Director, DBO-Outsourcing, Site Budgets, and Business Analytics, MyoKardia, Inc. Panelists: Jennifer Trevor, Ph.D., Sr. Portfolio Sourcing Manager, Portfolio Sourcing and Relationship Management, Astellas Pharma | 02/19/2019-02/20/2019 | Orlando, FL |
ICH E6 GCP Interactive Workshop – How to Build A Sponsor Risk Management Program |
Presented by FDAnews and Technical Resources International Inc. For clinical trials, it’s a new ball game. The ICH E6 (R2) guidelines now require trial sponsors to institute risk assessment at both the system and clinical trial levels; and require drug and biologics makers to qualify vendors. Trial sponsors now must institute risk assessment at both the system and clinical-trial levels. Have you established your program yet? Is your maintenance program complete? If not, this hands-on, interactive workshop is just the ticket. Prepare to discover:
| 12/11/2018-12/12/2018 | Raleigh, NC |
Clinical Trial Risk and Performance Management Summit |
A Metrics Champion Consortium/CenterWatch Event Come to Princeton Nov. 14 and 15 for the first-ever Metrics Champion Consortium Summit. This will be an exclusive gathering of the top minds in trial performance metrics, spearheaded by MCC Executive Director Linda Sullivan. Our keynote speaker will be Ken Getz, Associate Professor and Director, CSDD, Tufts University and Founder and Board Chair, CISCRP, clinical trials guru, founder of CenterWatch and an MCC partner. Linda and Ken and our roster of experts will guide you through the issues that are top of mind in clinical trials metrics today:
| 11/14/2018-11/15/2018 | Princeton, NJ |
Institute of Clinical Research—Project Management Forum | Thursday October 19, 2018 • Farnborough in the UK Presenter: Keith Dorricott Presentation Topic: “Risk Assessment in the era of ICH E6 (R2): Building on the TransCelerate Risk Assessment and Categorization Tool (RACT)” | 10/19/2018-10/19/2018 | |
Retooling Risk-Based Quality Management Approaches in the Era of ICH E6(R2) | Mark your calendar for Thursday, Oct. 18, when Linda Sullivan, Co-Founder and Executive Director, Metrics Champion Consortium and Keith Dorricott, Director, Dorricott Metrics & Process Improvement Ltd, will discuss approaches sponsors are taking to align with ICH E6(R2). During 60 fast-paced minutes Linda and Keith will:
| 10/18/2018-10/18/2018 | Free Webinar |
