Cambridge Healthtech Institute’s Inaugural 

From QbD and Risk Assessment to
Risk-Based Monitoring

Laying the Foundation
February 24-25, 2015 | Hyatt Regency Orlando | Orlando, FL 

Building quality and risk management into the design and planning of clinical trials leads to earlier detection and resolution of issues and higher overall quality of clinical trials. Proactively applying Quality by Design (QbD) principles into clinical trials improves trial efficiency and ensures data quality. Cambridge Healthtech Institute’s Inaugural "From QbD and Risk Assessment to Risk-Based Monitoring” conference provides guidance on how to proactively build quality standards into clinical trial conduct with emphasis on identifying appropriate key risk indicators and critical-to-quality metrics, thereby laying the foundation for successful risk-based monitoring.

Tuesday | Wednesday | Track Brochure | Full Event Brochure
Stay on for Part 2: Implementing Risk-Based Monitoring 

Tuesday, February 24

7:30 am Registration and Morning Coffee

8:25 Opening Plenary Keynotes

9:45 Grand Opening Coffee Break in the Exhibit Hall


10:45 Chairperson’s Remarks
Gregory Moody, Executive Director, Life Science Analytics, PerkinElmer Informatics 

10:50 Quality by Design and Proactive Quality Risk Management: Planning for High-Quality Clinical Trials

David NickersonDavid Nickerson, Senior Director, Portfolio Quality & Risk Management, Pfizer

Historical approaches to quality management in clinical trials have been heavily reliant on review of documentation at sites and retrospective audits/inspections. While these techniques will undoubtedly continue to play an important role in the oversight of quality in clinical trials in the future, it has been recognized that more proactive approaches that target the prevention of quality-related issues before they occur must be a priority. This presentation will outline an approach that Pfizer has implemented with the objective to build quality into clinical trials from the beginning and to prevent issues from occurring during study conduct which may undermine trial quality.

11:15 Risk-Based Quality and Compliance Management in Clinical Trials with Combination Products

Marina MalikovaMarina Malikova, Ph.D., Executive Director, Surgical Translational Research: Operations and Compliance, Surgery, Boston University Medical Center

A risk-based approach requires not only a strategy but tools to define key indicators to measure specific risks. As reference from the recent FDA and EMA guidances, Key Risk Indicators (KRIs) and Critical to Quality (CTQ) metrics should focus on “what really matters” and safety of research subjects and data integrity should be emphasized. Combination products, due to their specific nature, can increase risks while being tested in clinical trials. These critical metrics should be linked to particular processes within development program for combination products.

11:40 QbD and Risk Management: How One Company Is Designing and Implementing a Solution

Brian NugentBrian Nugent, Associate Director, Clinical Operations & Process, Gilead Sciences

During this presentation we will look at a quality framework and how risk management and QbD fit within the design, specific aspects covered will be: 1. An example of a Quality Framework as well as sub-frameworks that address risk management and quality control 2. How the QbD system was designed including initial build and ongoing maintenance 3. Review of implementation challenges and solutions 4. The role of risk management training as a foundational element of risk management 5. Example of risk tools designed to communicate down acceptable risk tolerances and communicate up residual risk status.

Medidata12:05 pm A Comprehensive and Systematic Approach to Risk-Based Monitoring

Elashoff_BarbaraBarbara Elashoff, Product Manager, Risk-Based Monitoring, Medidata

Big data is being generated by everything around us at all times. Every digital process and social media exchange produces it, including clinical trials. Harnessing the power of big data analytics is the latest advancement in risk-based monitoring (RBM). This presentation will discuss how such information can be used for RBM to improve data quality beyond what key risk indicators (KRIs) can provide. Examples will be discussed to illustrate how the use of centralized statistical analytics enable life sciences organizations to quickly realize the quality, cost and timeline benefits of RBM using patient data in addition to operational data.

12:35 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

1:15 Session Break


1:25 Chairperson’s Remarks

Brian Nugent, Associate Director, Clinical Operations & Process, Gilead Sciences


1:30 QbD Requires Standards and Sharing of Best Practices: The Role and Contribution of ACRES

Beat WidlerBeat Widler, Ph.D., Managing Partner, Widler & Schiemann Ltd.

QbD as well as quality risk management and risk-based monitoring require eliminating uncertainties about participants or contributors to a clinical trial. This means, the goal of any sponsor – be this an academic, commercial or even a patient group that is a sponsor – must be to acquire confidence that stakeholders involved have reliable processes and are able to consistently deliver quality, i.e., ensuring patients’ safety, integrity and rights as well as data integrity. ACRES brings the shared platform to the table that is an essential enabler of QbD! 

1:55 Identifying Risk When Doing Risk-Based Monitoring

Michael HowleyMichael Howley, Ph.D., Associate Clinical Professor, College of Business, Drexel University

Risk is an increasingly important concept for the clinical trials industry, especially as applied to risk-based monitoring. Indeed, all of clinical trial oversight depends on the ability to locating the risks within a clinical trial. In this session, I will show managers how they can identify risks with clinical trials using performance measures and apply these techniques to improve their oversight of clinical trials.

2:20 Q&A with Session Speakers on Building Quality into Clinical Trials & Monitoring

Beat Widler, Ph.D., Managing Partner, Widler & Schiemann Ltd.

Michael Howley, Ph.D., Associate Clinical Professor, College of Business, Drexel University


3:00 Refreshment Break in the Exhibit Hall

4:00 Find Your Table and Meet Your Moderator

4:05 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.

View Detailed Interactive Breakout Discussion Groups 

5:00 Welcome Reception in the Exhibit Hall

6:15 Close of Day

Tuesday | Wednesday | Track Brochure | Full Event Brochure
Stay on for Part 2: Implementing Risk-Based Monitoring 

Wednesday, February 25

7:30 am Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee

8:25 Plenary Keynote Session

9:45 Coffee Break in the Exhibit Hall


10:45 Chairperson’s Remarks

Given_KyleKyle Given, Principal Consultant, Risk-Based Monitoring, Medidata Solutions


10:50 FEATURED CO-PRESENTATION: Implementing RBM at Boehringer Ingelheim – The Quality by Design Aspects

Andy LawtonAndy Lawton, Global Head, Data Management, Biometrics & Data Management, Boehringer Ingelheim Ltd.


Mary MillsMary Mills, President, CRA Consultant, Mary Mills, LLC

The Quality by Design aspects are critical to RBM, this presentation will cover the essential QbD aspects of early Risk Assessment with feedback into Protocol design, Data Categorisation to clearly identify where to focus activity and in the umbrella document – the Integrated Quality and Risk Management Plan (IQRMP). This provide a robust building block to the RBM activities. Andy Lawton co-authored an article in the journal, Therapeutic Innovation & Regulatory Science: Defining a Central Monitoring Capability: Sharing the Experience of TransCelerate Biopharma's Approach, Part I. 

11:40 Risk-Based Monitoring Implementation Tips

ClaudiaLopezClaudia Lopez, DVM, MSc, Associate Scientific Director, Takeda Pharmaceuticals

Sponsors are tasked with the responsibility of maintaining patient protection during a clinical study, and risk-based models in the monitoring of clinical trial quality allow study monitors to focus on central site activities, such as ensuring human protection, identifying areas of needed improvement, and training team members on established or amended protocols. RBM provides tools to monitor quality of clinical trials, in this session attendees will be provided insight into experiences with risk-based monitoring as a strategy for improved quality of clinical trials. Topics covered include: 1. Employment of centralized & off-site technologies to support site, processes, subject safety, & data quality; 2. Risk-based monitoring (RBM) as it positively impacts quality of clinical trials; 3. Tips for easy transition to risk-based monitoring

12:05 pm Systematic Risk Assessment as the Blueprint for Quality Clinical Studies and Risk-Based Monitoring – An Update

Sun_StephenStephen Sun, CMO, M.D., MPH, ParagonRx, an inVentiv Health Company

Methods from FDA/ICH Q9 Quality Risk Management (QRM) Guidance for Industry serve as the foundation for providing a comprehensive approach for developing quality-by-design studies and risk-based monitoring strategies.  The Systematic Risk Assessment, using industry standard risk management tools, e.g., Root Cause Analysis (RCA), Failure Mode and Effects Analysis (FMEA), and Hazard Analysis and Critical Control Points (HACCP), methodically assesses, prioritizes and controls each of the risks identified in a clinical study. QRM offers a methodical and accepted roadmap from protocol development to ensuring the correct indicators are included in the central monitoring dashboard. 

  • Successful risk management requires QRM expertise, functional subject matter expertise, and a specified project scope
  • A case study with a large pharmaceutical company is presented to show how the findings from a “Systematic Risk Assessment” thread the identification of risks all the way to how risks are controlled and communicated as a defensible body of evidence
  • Outputs of Systematic Risk Assessments identify interventions for fixed risks and risk indicators, thresholds and corrective actions for dynamic risks that are tailored for each clinical study

12:35 BRIDGING LUNCHEON PRESENTATION: Implementing a Risk-Based Monitoring Approach: A CRO Perspective

Alexander ArtyomenkoAlexander Artyomenko, Ph.D., M.D., Global Director Late Phase, Medpace

Realizing the potential of Risk-Based Monitoring (RBM) requires coordination and collaboration across functions within both the Sponsor and CRO organizations. Working on RBM implementation with various sponsors presents puts a partner CRO into the unique perspective. The attendees will learn about the main challenges and solutions when taking a holistic approach to build a customized adaptive monitoring program, while working with the medical, operational and technology teams.

1:15 Session Break/Close of Conference

Tuesday | Wednesday | Track Brochure | Full Event Brochure
Stay on for Part 2: Implementing Risk-Based Monitoring 

Japan-Flag Korea-Flag China-Simplified-Flag China-Traditional-Flag  


2015 Final Agenda Image 

> Premier Sponsors 


Bio Clinica Logo 


Drug Dev 


IMS Health  




Oracle Health Sciences(1) 

PRA Health Sciences 


> View All Sponsors 

> View Media Partners 

> View Attendee List 

> Attendee Profile