Cambridge Healthtech Institute's 4th Annual

Implementing Risk-Based Monitoring - Part 2:
( リスクベースモニタリングの導入−パート2 )

Ensuring Effective and Efficient Monitoring and Data Quality

2018年2月14-15日 | Hyatt Regency Orlando | フロリダ州オーランド




Wednesday, February 14

11:30 am Registration Open

12:10 pm 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 Plenary Keynotes

3:00 Valentine's Day Celebration in the Exhibit Hall, Last Chance for Exhibit Viewing


4:00 Chairperson's Remarks

4:05 PANEL DISCUSSION: A Cross-Functional Look at RBM from Abbott Nutrition's RBM Task Force

Sonya_VerrillSonya Verrill, Manager, Clinical Projects, Clinical Operations, Abbott Nutrition


Geraldine_BaggsGeraldine Baggs, Ph.D., Principal Research Statistician, Statistical Sciences, ANRD Scientific and Medical Affairs, Abbott Nutrition

Dione_SmartDione Smart, Research Data Coordinator, Clinical Data Management, Abbott Nutrition

Sue_ZhangXiaosong (Sue) Zhang, MS, MAS, Staff Statistical Analyst, Clinical Program & System Support, Abbott Nutrition

Abbott Nutrition has established a cross-functional RBM task force to address changes brought about by implementing RBM. Members from the following groups: Stats, ClinOps, Programming, and CDM will discuss change management, their successes and challenges, refinements and tools in their journey to implementing RBM.

4:55 Sponsored Presentation (Opportunity Available)

5:25 RBM Journey: RBM 1.0 to RBM 2.0 with Case Study on a Pilot

Nurcan_CoskunNurcan Coskun, Ph.D., Global Risk Based Monitoring Program and Technology Solutions Manager, Medtronic

This presentation will discuss: 1. Harmonization of two organizations RBM methodology in Medical Device setting, 2. Future state process development with tools and transition to system and technology solutions, 3. Sharing a case study of RBM 2.0 pilot implementation, and 4. The challenges around change management and getting everyone aligned to the same direction in a multi-BU company like ours as part of the journey.

5:50 Close of Day

5:50-7:00 pm Track Reception (Sponsorship Opportunity Available)

Thursday, February 15

7:15 am Registration Open

Accenture7:45 Breakfast Presentation to be Announced


8:30 Chairperson's Remarks

Andy Lawton, Director & Consultant, Risk Based Approach Ltd.

8:35 Best Practices and Observations from Implementing TransCelerate's Risk-Based Monitoring Model Framework

Suzanne Lukac, Director, Risk-Based Monitoring Implementation, Merck

Although Regulators were urging companies to move to a risk-based approach, no model framework existed to enable organizations to successfully deploy and scale risk-based monitoring. To address this, a collaboration of 18+ Sponsor Companies worked in an unprecedented way to develop a model approach for risk-based monitoring. This session will share the latest work of this initiative, including new tools to assist implementation, best practices for adoption, and post-adoption metrics and observations.

9:00 Developing a Risk Repository

Adrienne Strickler, Associate Director, Risk Management-Central Monitoring, Janssen

What comes next after your Risk-Based Monitoring process is established? Process improvement! After 4 years of RBM at Janssen R&D, our portfolio has grown to include well over 150 trials and we are now able to gain efficiencies by applying lessons learned across similar studies. One key way to do so is through a central risk repository that can be used to streamline RBM set-up and implementation for new trials.

9:25 CO-PRESENTATION: The Quality Journey - A Small Companies Approach to the Implementation of ICH E6 and RBM

Yiwen_SunYiwen Sun, Senior Clinical Research Associate, Samumed, LLC

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

This presentation will be in two parts, firstly examining the overall quality imperative within the clinical trial arena and the second part will focus on Samumed's ICH E6 and RBM journey to current status and future direction. Key points: 1. Understand the quality requirement expected of sponsors, 2. What can be achieved by a small company, current status, and 3. Future direction.

10:15 Networking Coffee Break


10:30 Chairperson's Remarks

Andy Lawton, Director & Consultant, Risk Based Approach Ltd.

10:35 RBM: A Larger Sponsor's Approach

Taras_CarpiacTaras Carpiac, Director, Global Development Operations, Amgen

Amgen began its RBM journey in 2012. In the years since, Amgen has continued to make investments in its RBM process and tools in order to align with regulations and in response to industry developments. This presentation will examine the principles of Amgen's RBM model and highlight areas of new focus.

11:00 Presentation to be Announced

11:25 Brief Session Break

Bioclinica_new11:35 Presentation to be Announced

12:00 pm PANEL DISCUSSION: What Lies in the Future for RBM?

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


Yiwen_SunYiwen Sun, Senior Clinical Research Associate, Samumed, LLC

Taras_CarpiacTaras Carpiac, Director, Global Development Operations, Amgen

As the biopharma industry perfects the process of RBM, we will discuss the possibilities that lie ahead for RBM and its resulting data: In what capacity will onsite monitoring continue? Can onsite monitoring ever be eliminated? What are some possible uses for the data generated from RBM? Are there data patterns and predictive markers seen in the data?

12:50 Closing Remarks

1:00 SCOPE Summit 2018 Adjourns

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)