This Summit offers pharmaceutical and medical device delegates concrete examples of how to build a framework and methodology for a risk-based monitoring (RBM) program that is part of an overall risk management approach to study planning and oversight. One of the biggest challenges of implementation is overcoming resistance to change as no organization wants to be the first. For that reason, Summit faculty share change management strategies for people, processes, and technology that led to the effective implementation of their RBM programs. The Site’s perspective, assessing readiness for change and providing support during the change process must not be overlooked. Strategies to partner with Sites to achieve stronger connectivity will also be discussed.

1. S a v e u p t o $ 6 0 0 w h e n y o u r e g i s t e r b y F r i d a y, d e c e m b e r 1 2 , 2 0 1 4 !
T h e Wo r l d C o n g r e s s S u m m i t o n
Risk-Based Monitoring
and the Quality Risk Management of Clinical Trials
Assess, Control, Review, and Adjust Risk Across the Trial Lifecyle
January 27-28, 2015 | Wyndham Philadelphia Historic District | Philadelphia, PA
To p R e a s o n s to Attend
Drive your RBM strategy by benchmarking with early adopters
Maximize results through fostering collaboration between
clinical development and quality professionals
Improve connectivity between the Site and Sponsor
Negotiate a change management strategy across internal
and external stakeholders
Adapt the model and de-risk each clinical trial
Establish metrics to guide risk mitigation planning
Plus a Pre-Conference Workshop on:
Integrate, Analyze, & Plan Your QRM Strategy
Kimberly A. Wong Oleson
Senior Vice President,
Clinical Affairs
Sunshine Heart, Inc.
Christine Pierre
President
Society for Clinical
Research Sites
Mark Travers
Global Head,
Clinical Study Units
sanofi
Media Partners Organized by
Organized by:
People
Technology
Process
RBM
Featured Speakers include
Peg Connelly
Head, Portfolio Quality
Risk Management
Pfizer
Rachel Edwards, BSc, PhD
Director and
Regional Head for
Central and Emerging Europe,
Middle East and Africa,
Global Study Operations
Amgen
Margaret F. Fay, PhD, RN, CCRC
Director, Global Clinical Monitoring,
Clinical Operations
Medtronic, Inc.
David W. Fryrear
Senior Director, Clinical and
Pharmacovigilance Quality Assurance
AbbVie
Janis Little
Vice President,
Global Regulatory Quality
Allergan
To register, please visit www.worldcongress.com/rbm • Phone: 800-767-9499 • Fax: 781-939-2543 • Email: wcreg@worldcongress.com

2. T h e Wo r l d C o n g r e s s S u m m i t o n
Risk-Based Monitoring
and the Quality Risk Management of Clinical Trials
T h i s s u m m i t o ff e r s :
20 expert speakers in clinical
trial oversight and quality
risk management
14 small, mid-sized, and large
trial sponsor perspectives
4 clinical research
site leaders
4 case studies
w h o s h o u l d a tt e n d :
Pharmaceutical and
Medical Device Industries
Clinical Operations
Quality Assurance
Quality Auditing
Safety
Data Management
Study Monitoring
Biostatistics
Clinical Research Sites
Investigator
Clinical Research Coordinator
Site Director
Dear Colleague,
Clinical trials must be conducted more safely and efficiently if patients are to benefit from
new therapies in the development pipeline. Risk management throughout the product
lifecycle from the study planning phase to its conclusion enables a trial sponsor to reduce
or prevent risk or lessen the severity of a harmful event. Risk-based approaches, adapted
to each trial, allow the Sponsor to not only address cost, but better identify, manage, and
remove risk to ensure patient safety and data quality.
The World Congress Summit on Risk-Based Monitoring and the Quality Management of
Clinical Trials offers pharmaceutical and medical device professionals a forum where they
can learn from peers and experts who are taking steps to implement risk-based monitor-ing
using a quality risk management or quality by design approach to conducting clinical
trials. Specific topics on the agenda include:
• An end-to-end risk management model
• The evolving role of the clinical quality professional in risk-based approaches
• Change management strategies for people, processes and technology
• How to link your risk assessment to build better protocols
• RBM metrics
• How to create better connectivity between the Site and Sponsor
• Strategies for large, mid-sized, and small trial sponsors
• Central monitoring and key enablers
If you are open to adopting new practices and committed to improving the clinical trial
process, you don’t want to miss this Summit. I look forward to meeting you on
January 27-28, 2015 in Philadelphia.
Sincerely,
P.S. Don’t forget about
the team discount. Find
out more about special
group package discounts
by calling 800-767-9499
or emailing wcreg@
worldcongress.com
Brett Wilson
Associate Director, Global Business Development, Operations, Brist ol-Myers Squibb
TransCelerate RBM Workstream Co-Lead
Chairperson, World Congress Summit on
Risk-Based Monitoring and the Quality Risk Management of Clinical Trials
CONSIDER A SPONSORSHIP PACKAGE
• Present to Key Players in Your Target Market • Take Advantage of 1-on-1 Sponsor/Attendee Meetings Facilitated On-Site
CAPTURE A TRUE ROI Throu gh Spo nsors hip of the Following:
Agenda Thought Leadership • Networking Cocktail Reception • Breakfast Symposia • Luncheon • Executive Networking Breaks
To inquire about Sponsorship, Exhibit, Branding, and Executive Networking Opportunities, Contact:
Suzanne Caroll, Manager, Business Development, World Congress • Call 781-939-2648 or email suzanne.caroll@worldcongress.com
To register, please visit www.worldcongress.com/rbm • Phone: 800-767-9499 • Fax: 781-939-2543 • Email: wcreg@worldcongress.com

3. DAY ONE – Tuesday, January 27, 2015 • Pre-Summit Workshop
7:30 am –
8:30 am Workshop Registration and Morning Coffee
8:30 am –
11:45 am INTERACTIVE Workshop: Integrate, Analyze,
& Plan Your Quality Risk Management (QRM) Strategy
An educational, skill building workshop that offers attendees examples, and an opportunity
to engage in case study group exercises, designed to enhance their capabilities to develop
integrated QRM processes and assess and manage risk utilizing these principles.
I. Recognize How to Integrate QRM within Clinical Quality Systems
• Develop strategies to successfully integrate QRM in GCP
• Apply QRM to study site management and to optimize performance
• Learn how to promote QRM at the research sites
• Case study group exercise
II. Utilize QRM to Analyze Risk and for Action Planning
• Adapt various risk assessment models to GCP
• Assign risk thresholds based on systems and project specific needs
• Identify effective tools to grade and score areas of risk
• Build a QRM plan linked to safety, data, and monitoring study plans
• Case study group exercise
Interactive Session:
Breakout group discussions!
Sandra “SAM” Sather, MS, BS, CCRC, CCRA, Member, ACRP Academy Boar d of Trust ees a nd Regulatory Affairs Comm itt ee
Ms. Sather is an industry veteran whose mission is to promote clinical quality systems worldwide for investigational sites, sponsors/ CROs
and ethics committees. She has over 25 years of clinical experience with a Master of Science in Education with a specialization in Training
and Performance Management. In 2002, Ms. Sather co-founded Clinical Pathways, a clinical research consulting firm located in the Research
Triangle Park area in North Carolina, USA, and works with sponsors, vendors, and sites relating to drug and device trial execution. She is dual
certified by the Association for Clinical Research Professionals (ACRP), serves on the ACRP Academy Board of Trustees and Regulatory Affairs
Committee (RAC). She is a frequent facilitator and speaker for industry projects and events.
There is a 15 minute coffee and networking
break from 10:00 am – 10:15 am
11:45 am –
1:00 pm Lunch on Your Own/Main Summit Registration
DAY ONE – Tuesday, January 27, 2015 • main Summit
1:00 pm –
1:15 pm Chairperson’s Welcome
Brett Wilson
Associate Director, Global Business Development, Operations
Brist ol-Myers Squibb
TransCelerate RBM Workstream Co-Lead
1:15 pm –
2:00 pm Is Risk-Based Truly Risky? An Industry Perspective on Risk Based Approaches
for Clinical Trial Conduct
• Examine the external factors in our landscape that drive change in the way that clinical trials are conducted
• Analyze the common myths about risk-based monitoring
• Determine the business value of risk-based trial conduct
Kimberly A. Wong O leson
Senior Vice President, Clinical Affairs
Sunsh ine Heart , I nc.
2:00 pm –
2:45 pm Link Your Risk Assessment to Your Study Protocol – Better Identify, Manage,
and Remove Risk
• Discuss the importance of having a cross-functional team
• Gain insights on where the risk assessment process best benefits protocol development
• Perform the risk assessment concurrent with study protocol development
• Hear the latest refinements on the RACT tool and examples of how it’s been working in practice
Jessica Holthuizen
Clinical Operations Head
Johnson & Johnson
To register, please visit www.worldcongress.com/rbm • Phone: 800-767-9499 • Fax: 781-939-2543 • Email: wcreg@worldcongress.com

4. DAY ONE – Tuesday, January 27, 2015 (continued)
2:45 pm –
3:15 pm Networking and Refreshment Break
3:15 pm –
4:00 pm Lessons Learned on RBM Metrics — Results from the TransCelerate Pilots
• Examine lessons learned from TransCelerate pilots including measures that were developed around quality, efficiency, and cycle time
• Evaluate the contribution that Source Data Verification (SDV) and review makes to clinical trial safety and data quality
• Hear case examples:
– metrics – SDV – Change management support
Brett Wilson
Associate Director, Global Business Development, Operations
Brist ol-Myers Squibb
TransCelerate RBM Workstream Co-Lead
Case Study
4:00 pm –
4:45 pm Enhance Connectivity between the Site and Sponsor for Effective Implementation
• Hear results from a Linking Leaders and SCRS survey on perceptions of the impact of RBM
• Discuss the importance of transparency, education, tools, and other resources in communicating an RBM approach and methodology
• Identify ways for the site and sponsor to become proactive partners to implement change
Janis L ittle
Vice President, Global Regulatory Quality
Allergan
Christine Pierre
President
Society for Clinical Research Sites
Case Study
4:45 pm –
5:45 pm
Panel
Dual Perspectives — Sites and Sponsors on Achieving Alignment
• Evaluate and adapt organizational structure and culture to support RBM
• Negotiate a management strategy and influence change at the Sites
• Address the issue of the patient’s perception and the impact of ‘risk’ versus ‘adaptive’ monitoring terminology
Moderator:
Christine Pierre
President
Society for Clinical Research Sites
Panelists:
Rachel E dwards, BSc, PhD
Director and Regional Head
for Central and Emerging Europe,
Middle East and Africa, Global
Study Operations
Amgen
Vince G illen
Director, Lehigh Center
for Clinical Research
Yvonne McCracken
Vice President, Operations
and Compliance, RxTrials
Jane M. Shen, PharmD
Director, Strategic Relationships
PMG Research , I nc.
Craig Wozniak
Head, Americas Clinical Operations, Therapy
Area Delivery, GlaxoSmith Kline
5:45 pm –
6:45 pm Cocktail and Networking Reception
DAY two – Wednesday, January 28, 2015
7:30 am –
8:30 am Morning Coffee
8:30 am –
8:45 am Chairperson’s Welcome and Review of Day One
Brett Wilson
Associate Director, Global Business Development, Operations
Brist ol-Myers Squibb
TransCelerate RBM Workstream Co-Lead
8:45 am –
9:30 am Medtronic’s Innovative End-to-End Quality Risk Management Model
• Learn how quality risk management can be engineered for a successful program through the total lifecycle of trial conduct
• Identify the main deliverables, processes, and systems
• Hear Medtronic’s experience with implementation of QRM processes and tools
Margaret F . F ay, PhD, RN, CCRC
Director, Global Clinical Monitoring, Clinical Operations
Medtr onic, I nc.
Case Study
To register, please visit www.worldcongress.com/rbm • Phone: 800-767-9499 • Fax: 781-939-2543 • Email: wcreg@worldcongress.com

5. DAY two – Wednesday, January 28, 2015 (continued)
9:30 am –
10:15 am
Panel
Break Down the Silos between Clinical Quality and Operations Professionals
for Improved Trial Execution
• Outline steps to embed quality-by-design and continuous quality improvement
• Define the roles between clinical and quality team members
• Collectively determine areas of risk to develop an RBM strategy
• Establish “quality as a culture” within the organization
Moderator:
Arti Bajpai
President, Comp liance
Quality I ntegrat ion
(CQI ) Consulting
Panelists:
David W. F ryrear
Senior Director, Clinical
and Pharmacovigilance
Quality Assurance, Abb Vie
Kevin Douglass
Associate Director,
Data Management
Daiich i Sankyo
Peg Connelly
Head, Portfolio Quality
Risk Management
Pfizer
10:15 am –
10:45 am Networking and Refreshment Break in the Executive Networking Lounge
10:45 am –
11:30 am How We Did It — A Site, Trial Sponsor, and CRO RBM Pilot Study
• Discuss how implementation of RBM allows a site, trial sponsor, and CRO to share accountability for integrated quality and risk management
• Identify criteria and outline a plan for partnering on the right trial and processes
• Evaluate lessons learned and results to-date
Thought Leaders TBA
Case Study
11:30 am –
12:30 pm
Panel
Meet the Challenges of RBM Implementation for Small to Mid-Sized
Trial Sponsors
• Discuss the advantages and disadvantages of utilizing a risk-based monitoring strategy
• Address the cost of RBM implementation in accordance with the investors’ expectations
• Analyze alternative models through CRO partnerships with clinical operations
Moderator:
Deven V. Parmar, MD, F CP
Director - Clinical Development
Prolong Pharmac euticals
Panelists:
Jessica L ee, MS, MPH
Vice President,
Clinical Operations
Inovio Pharmac euticals
Shailesh Chavan, MD
Senior Director, Clinical Development,
Drug Safety and Medical Affairs
Biotest Pharmac euticals
12:30 pm –
1:30 pm Luncheon in the Executive Networking Lounge
1:30 pm –
2:15 pm Facilitate Central Monitoring Methodology to Cost Effectively Prevent Risk
• Evaluate technology requirements to do effective central monitoring
• Hear examples of the various models that TransCelerate member companies are piloting
• Learn critical people, process, and technology enablers
Mark Travers
Global Head, Clinical Study Units
sa nofi
2:15 pm –
3:00 pm
Interactive
Q&A
Moving the Needle on RBM — Ask the Experts
Get your most pressing questions answered by a panel of experts and leave with an action plan.
• Learn how to take your RBM pilot to the next level
• Gain practical advice for overcoming internal hurdles in adopting a risk-based approach
• Hear perspectives on what the future of risk-based trials could look like and how we should begin to prepare for the future now
Moderator:
Mark Travers
Global Head,
Clinical Study Units
sa nofi
Panelists:
Deven V. Parmar, MD, F CP
Director, Clinical
Development, Prolong
Pharmac euticals
Additional Panelists TBA
3:00 pm Chairperson’s Closing Remarks, Close of Summit
To register, please visit www.worldcongress.com/rbm • Phone: 800-767-9499 • Fax: 781-939-2543 • Email: wcreg@worldcongress.com

6. S a v e u p t o $ 6 0 0 w h e n y o u r e g i s t e r b y F r i d a y, d e c e m b e r 1 2 , 2 0 1 4 !
Registration Fee: Register By
12/12/2014
Register By
1/09/2015
Register By
Standard 01/27/2015
Conference $ 1795.00 $ 2095.00 $ 2395.00
Conference Plus 1 Workshop $ 1995.00 $ 2295.00 $ 2595.00
pharma & biotech
Conference $ 1195.00 $ 1495.00 $ 1795.00
Conference Plus 1 Workshop $ 1395.00 $ 1695.00 $ 1995.00
Fee for conference includes welcome coffee, lunch, reception,
refreshments, and web-based conference documentation available
pre- and post-event, accessible through password-protected website.
Checks in U.S. funds drawn from U.S. bank payable to: WC Research Inc.
No personal checks accepted. Verification may be required for rate
approvals. Please contact us should you have any special needs.
SPECIAL TEAM DISCOUNTS: Your organization may
send ONE executive FREE for every three delegates
registered. All registrations must be made at the same
time to qualify. To register your team, contact us at 800-767-9499.
Participant Substitution and Cancellations:
Your registration may be transferred to a member of your organization
up to 24 hours in advance of the conference. Cancellations received
in writing on or before 30 days prior to the start of the event will be
refunded, less a $395 administrative charge. No refunds will be
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administrative charge can be credited to another World Congress
conference if you register within 6 months from the date of this
conference. In case of conference cancellation, World Congress’
liability is limited to refund of the conference registration fee only.
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a comparable World Congress conference of your choice.
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T h e Wo r l d C o n g r e s s S u m m i t o n
Risk-Based Monitoring
and the Quality Risk Management of Clinical Trials
Assess, Control, Review, and Adjust Risk Across the Trial Lifecyle
January 27-28, 2015 | Wyndham Philadelphia Historic District | Philadelphia, PA
Featured Speakers include
Janis Little
Vice President,
Global Regulatory Quality
Allergan
Jessica Holthuizen
Clinical Operations Head
Johnson & Johnson
Peg Connelly
Head, Portfolio Quality
Risk Management
Pfizer
Craig Wozniak
Head, Americas Clinical Operations,
Therapy Area Delivery
GlaxoSmithKline
• QbD Protocol Design
and Conduct
• Quality Risk Management
• Risk-Based Monitoring
• Risk-Based Auditing
• Sponsor-Site Alignment
To register, please visit www.worldcongress.com/contactcenters • Phone: 800-767-9499 • Fax: 781-939-2543 • Email: wcreg@worldcongress.com
To register, please visit www.worldcongress.com/rbm • Phone: 800-767-9499 • Fax: 781-939-2543 • Email: wcreg@worldcongress.com