Cambridge Healthtech Institute's 4th Annual

Implementing Risk-Based Monitoring - Part 1:
( リスクベースモニタリングの導入−パート1 )

Integrating Quality into Clinical Trials

2018年2月13-14日 | Hyatt Regency Orlando | フロリダ州オーランド


リスクベースモニタリングの導入をテーマにしたこのカンファレンスプログラムのパート1では、治験実施の国際基準であるICH-E6 R2の最新の改訂版を含む品質についての新たな基準やガイドラインを中心に、品質基準を総合的かつ積極的に構築していくための方策が示されることになっており、質の高い臨床試験を実現し、リスクベースモニタリングの手法を成功裏に導入するための基盤整備に役立てることができます。


Monday, February 12

9:00 am - 7:30 pm Registration Open

5:00 - 6:15 pm Pre-Conference Plenary Keynote Panel

6:30 - 8:30 pm SCOPE’s Kick-Off Networking Happy Hour on the Garden Terrace Hosted by CHI, DrugDev, & Praxis

8:30 Close of Day

Tuesday, February 13

7:15 am Registration Open and Morning Coffee

8:20 Opening Plenary Keynotes

9:45 Grand Opening Coffee Break in the Exhibit Hall


10:45 Chairperson’s Remarks

Janis Little, Vice President, Global R&D Quality, Allergan

10:50 PANEL DISCUSSION: The Total Cost of Quality: Finding the Balance Between Investing in Quality and the Cost of Fixing Quality Problems

Moderator: Linda_SullivanLinda Sullivan, Co-Founder & President, Metrics Champion Consortium LLC


Mayuri Trehan, Associate Director, Quality Management, Global Clinical Research and Development Organization, Celgene

Armelde_PitreArmelde Pitre, Senior Director, Quality Performance Management and Analytics, Pfizer, Inc.

Few organizations have a complete understanding of the financial impact of poor clinical trial quality. With better understanding of poor quality on an organization’s bottom line, it can improve buy-in for proactively investing in quality to avoid costly quality problems. In this panel, representatives from across pharma will come together to discuss the sources of poor clinical trial quality (ex. protocol amendments, low/non-enrolling sites, subjects dropping out, data quality issues, etc.), the challenges of estimating poor quality costs, current quality cost estimate techniques including the Cost of Poor Quality Estimator Tool developed by the MCC Study Quality Trailblazer Group, and how improved access to data about the cost of poor quality is impacting risk management and quality investment decisions.


11:40 Quality by Collaboration: Practical Applications

Jolie Weintraub, Executive Director, TA Head Oncology, MRL Quality Assurance, Merck

This presentation will discuss how quality is implemented within Merck, including the importance of collaborating with various quality functions at all levels of the organization. It will provide a holistic approach to supporting and achieving quality proactively throughout the clinical trial process. In addition, case studies will be shared on how this principle has been put into practice and steps to take to foster the collaborations.

12:05 pm Sponsored Presentation (Opportunity Available)

12:30 Session Break

12:40 Luncheon Presentation to be Announced

1:20 Coffee and Dessert Break in the Exhibit Hall


2:00 Chairperson’s Remarks

Linda Sullivan, Co-Founder & President, Metrics Champion Consortium LLC

2:05 TransCelerate’s Clinical QMS

Janis_LittleJanis Little, Vice President, Global R&D Quality, Allergan

The presentation will cover what a Clinical QMS is, and what the benefits are to sponsors in having a Clinical QMS defined and in place in alignment with ICH E6 (rev 2) requirements in Section 5. Audience will recognize and understand the flexibility of the TransCelerate Conceptual Framework for a Clinical QMS that will help sponsors design a customized CQMS for their specific needs. The presentation will dispel myths that exist on what a Clinical QMS “is” and what it is not, and it will cover what TransCelerate QMS publications and tools are currently available to industry. The presentation will also take a deep dive into a newly available tool for sponsors to assess a clinical quality management system (if they have implemented in alignment with the TransCelerate CQMS Conceptual Framework).

2:55 Envisioning a Quality Management System to Address the ICH E6 R2 Changes

Andy_LawtonAndy Lawton, Director and Consultant, Risk Based Approach Ltd.

The changes in ICH E6 R2 impact the fundamental basis of how quality should be addressed by a sponsor. This presentation will take a holistic look at the Regulatory background, and the tools that can be used to address the critical issues of Quality Tolerance Limits, Quality by Design, and Continuous Quality Improvement.

3:20 Risk-Based Monitoring Strategies for Improved Clinical Trial Performance

Henry_GalioHenry Galio, Senior Director, Vault CTMS, Veeva Systems

A strategic, risk-based approach to clinical trial management can aid sponsors and CROs in early detection and mitigation of risks that could affect the quality and safety of a study and its subjects. However, risk mitigation strategies have little value unless they are executed, monitored, and analyzed continuously throughout the trial’s lifecycle. This session explores how cloud-enabled solutions can be leveraged to gain real-time insights and actionable analytics to improve clinical trial safety and performance.


3:50 Find Your Table and Meet Your Moderator

4:00 Interactive Breakout Discussion Groups

Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the key issues presented earlier in the day’s sessions. Delegates will join a table of interest and become an active part of the discussion at hand. To get the most out of this interactive session and format please come prepared to share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing.

5:00 Welcome Reception in the Exhibit Hall

6:30 Close of Day

Wednesday, February 14

7:15 am Registration Open

7:45 Breakfast Presentation: A New Way to Pay: SaaS Technology and Outsourcing How You Need It

Stuart Thiede, President, Payments, DrugDev

8:15 Session Break


8:25 Chairperson’s Remarks

Rob Nichols, CCO, Algorics

8:30 An Overview of Today’s Guidelines for Clinical Quality Risk Management

David_NickersonDavid Nickerson, Head, Clinical Quality Management, EMD Serono

In today’s clinical trial landscape, there are several guidelines in place regarding clinical risk management. An overview of the latest regulatory updates such as the EMA guidelines and the ICH E6 addendum will be provided.

8:55 CO-PRESENTATION: The Impact of Technology on Clinical Trial Oversight to Ensure Quality and Meeting ICH E6 R2 Requirements

Brian_NugentBrian Nugent, Executive Director, Clinical Solutions and Compliance, Ultragenyx

Angie_MaurerAngie Maurer, RN, BSN, MBA, Clinical Operations Consultant, PALM/Clinical Operations, Gilead Sciences

Today there is an array of technological solutions bringing change to the processes involved in conducting clinical trials. This change is impacting everything from study start-up activities, data collection, and analysis of clinical trial data, to the monitoring of clinical trials. The big question is how is this technology really ensuring quality in clinical trials. During this presentation, we will be discussing the following:

  • What is Quality Management, and how can we ensure quality in clinical trials?
  • What are the specific Quality Management requirements in ICH E6 R2 that sponsor companies should pay close attention to when evaluating technologies for use in a clinical trial?
  • How has E6 impacted the use of homegrown risk systems?
  • Has technology increased the overall operational complexity and cost, or has it enabled us to provide cost effective trial management and oversight?

9:45 Talk Title to be Announced

Masha Hoffey, MS, Director, Clinical Analytics, Informatics, PerkinElmer

10:10 Coffee Break in the Exhibit Hall


11:10 Chairperson’s Remarks

11:15 PANEL DISCUSSION: ICH E6 and How the Industry Is Tackling Things Head On

David_NickersonDavid Nickerson, Head, Clinical Quality Management, EMD Serono


Jonathan_RoweJonathan Rowe, Ph.D., Executive Director & Head, Quality Performance and Risk Management, Pfizer

Eva Bush, Senior Director, QA Lead, Americas Audit Excellence Quality Assurance Team (AEQAT), Global Clinical Quality Assurance, QuintilesIMS

With the passage of ICH E6 (R2) addendum, the pharma industry is taking a closer look at how they approach clinical trial quality and oversight with their partners. This panel will cover how individual organizations are approaching ICH E6 R2 addendum changes, the struggles and challenges they faced or continue to face, and how they are working with other stakeholders (their CRO partners, stakeholders across different departments, etc.).

12:05 pm Session Break

12:10 Bridging Luncheon Presentation: Extracting Data from the EHR Dramatically Reduces the Need for Manual Monitoring. New Standards Make This Possible

Keith Howells, CTO, Omnicomm

12:50 Coffee and Dessert Break in the Exhibit Hall

1:30 Close of Conference

Melissa DolenGroup Discounts Are Available! Special rates are available for multiple attendees from the same organization. For more information on group discounts, contact us.


2018 SCOPE Conference at a Glance

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In Memory of Gerald "Jerry" Matczak
Matczak Jerry

Gerald "Jerry" Matczak, lead consultant in clinical innovation at Eli Lilly & Co., was a rare breed in the pharmaceutical world, someone who not only embraced social media, but also listened to activist patients. He has been a part of the SCOPE conference since its inception and won the Patient Engagement Award on Wednesday, the day before his passing. Matczak died suddenly on Feb. 2 at age 54. We will all miss him.

- Cambridge Healthtech Institute (CHI)