Event Archives
| Event Name | Event Description | Event Dates | Event Location |
|---|---|---|---|
Risky Business Forum | Date: September 20, 2019 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) | 09/20/2019-09/20/2019 | Uxbridge, UK |
Workshop: Building Capacity for Patient-Centered R&D | Date: September 16, 2019 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).
| 09/16/2019-09/16/2019 | Washington D.C. |
MCC Clinical Trial Risk and Performance Management Summit | Date: September 4-5, 2019
Come to the Clinical Trial Risk and Performance Management Summit and discover the secrets to implementing a successful metrics program. You’ll unlock the secrets to deciding what to measure; establishing your data requirements; aggregating reliable data; designing easy to understand metric reports; and using metrics to identify areas of concern and conduct root cause analysis. Check out this sampling of what you’ll explore over the course of an information-packed day-and-a-half:
| 09/04/2019-09/05/2019 | Philadelphia, PA |
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 |
