7th clinical quality oversight forum
TRANSCRIPT
www.exlevents.com/CQOF
Clinical Quality Oversight Forum7t
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October 17-19, 2016 | Hilton Philadelphia at Penn’s Landing | Philadelphia, PA
Sponsors and Exhibitors Association Partners
Kathy Goin, Vice President, Clinical Operations, TREVENA, INC.
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PFIZER CASE STUDY: VENDOR GCP QUALITY RISK MANAGEMENT FRAMEWORK Developing a GCP Quality Risk Management Framework for Managing Risk in Vendor EngagementsDeirdre Hall, M.S., Head, Vendor Quality Management, Clinical Development Quality (CDQ), PFIZER
INTERACTIVE SESSION: ACHIEVING A CONFIDENT STATE OF INSPECTION READINESS Outlining Effective Strategies to Ensure Your Vendors and Sites Are Inspection Ready
Facilitators:
JANSSEN CASE STUDY: BUILDING A QUALITY CULTURERecognizing the Benefits of a Culture of Quality and Strategies for ImplementationKrista Kerr, Associate Director, Team Lead Americas, R&D Quality and Compliance, JANSSEN
UCB CASE STUDY: COMMUNICATION GOVERNANCE Developing and Implementing an Effective Communication Governance Structure and Collaborative Partnership Angela Berns, Director and Head of Vendor Management, Clinical Quality Assurance, UCB BIOSCIENCES, INC.
Visionary Leaders Weigh in on the Changing Landscape of Clinical Quality and Compliance: ARE WE AT A TIPPING POINT?
EXPERT PANEL DISCUSSIONS: › What Happened to Simple Risk-Based
Monitoring? › Vendor Oversight Within Different
Outsourcing Models › Quality Management Systems› Risk-Based Auditing
Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP, Principal Specialist, Clinical Quality Assurance, BOSTON SCIENTIFIC
Michael R. Hamrell, Ph.D., RAC, FRAPS, RQAP-GCP, CCRA, President, MORIAH CONSULTANTS
Sunil Kotecha, Director, Regulatory Inspection Management, PFIZER
Cheryl McCarthy, RQAP-GCP, CQA, CBA, Associate Director, R&D Quality and Compliance, BIOGEN
Steve Whittaker, Senior Consultant, THE AVOCA GROUP; Executive Director, THE AVOCA QUALITY CONSORTIUM
Ann Meeker-O’Connell, Head, BioResearch Quality and Compliance, JOHNSON & JOHNSON
PRE-CONFERENCE DAYFULL-DAY INTERACTIVE SEMINARThe Changing GCP Regulatory Environment and the Impact on Clinical Compliance and Operations MORNING WORKSHOPAn Inspection-Ready Trial Master File AFTERNOON WORKSHOPA Streamlined Vendor Prequalification Approach
#CQOF Proactive GCP Compliance
MODERATOR SPEAKERS
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Ensuring Trial Integrity by Effectively Assessing, Optimizing and Managing the Quality of Clinical Vendors and Sites
Michele Weitz, Director, GCP Compliance Operations, CLOVIS ONCOLOGY, INC.
Matthew Krumrai, Associate Director, Clinical QA, ABBVIE
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2015 Audience ProfileClinical Quality Oversight Forum7t
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40%Clinical Quality/Compliance
Company
Function
Seniority
Who Should Attend?This event is designed for professionals from pharmaceutical, biotechnology and medical device companies; CROs; and other clinical service providers who have responsibilities in the following areas: › Quality Management/Clinical Quality Management
- Clinical Quality Assurance/QA/CQA - Clinical Quality Control/QC/CQC
› Clinical Operations/Management/Research/Development
› Compliance/Clinical Compliance/Regulatory Compliance
› Monitoring/Site Management/Study Management › Clinical Outsourcing/Vendor Management/Third-
Party Management › Good Clinical Practice/GCP › Auditing › Clinical Risk/Risk Assessment › Regulatory Affairs › Medical Affairs
The event is also of interest to:› Investigative Sites › Academic Research Organizations › Central, Imaging and ECG Labs › IVRS Companies › EDC Companies › Other Clinical Service Providers
Sponsorship and Exhibition Opportunities - Do You Want to Reach the Audience At This Event? Do you want to spread the word about your organization’s solutions for potential clients and prospects in attendance? Take advantage of the opportunity to exhibit, present an educational session, share your expertise on a panel discussion, host a networking event and/or distribute promotional materials at this conference. ExL works closely with our sponsors to create customized opportunities to fulfill your conference objectives.
To learn more about your options, please contact Alex Siegel, Event Sales Director, 917-242-3893 or [email protected].
Dear Colleague,
ExL’s Clinical Quality Oversight Forum continues to live up to its reputation as an elite gathering of senior-level executives. A meaningful exchange of ideas results from the audience’s willingness to candidly share their experiences, productively discuss strategies for improving oversight, and engage with one another. This unique interactive atmosphere makes for a valuable conference experience, ensuring participants leave with new ideas, strategies and practical tools for optimizing clinical quality, and the connections necessary to execute them. I look forward to seeing you in October.
Sincerely,
Kristen HunterKristen HunterEvent [email protected] 212-400-6241
70% Trial Sponsors
17% Other Clinical
Service Providers
5% Other
8% CROs
7% Consultants/Other
14%Other
8%Audits/Inspections
8%Outsourcing/Vendor
Management
30%Clinical Operations/
Management
24%Managers
69% Represented Director-Level and Above
40%Directors
9%VPs/SVPs/EVPs
20%Presidents/CxOs/DMs
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Monday, October 17, 2016 Pre-Conference Day
7:45 Registration and Continental Breakfast8:30
Examining Global Regulatory Changes and Evaluating Their Current and Anticipated Impact on Clinical Operations and GCP Compliance Michael R. Hamrell, Ph.D., RAC, FRAPS, RQAP-GCP, CCRA, President, MORIAH CONSULTANTSCeleste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP, Principal Specialist, Clinical Quality Assurance, BOSTON SCIENTIFIC Michele Weitz, Director, GCP Compliance Operations, CLOVIS ONCOLOGY, INC.› Examining the big picture of the evolving regulatory landscape and
understanding the drivers behind these changes › Breaking down the revisions to the ICH E6 GCP Guidelines
- Laying out the timeline - Detailing the changes to GCP
• Providing an in-depth analysis of the specific changes to oversight
› Discussing the new EU Clinical Trial Regulation 536/2014 › Assessing the new BIMO requirements› Recognizing the impact of the 2015 revision of the ISO 9001
quality standard › Anticipating the impact of the upcoming revisions to medical
device standards (ISO 14155)
12:00 Lunch for Seminar Participants
1:00
Examining Global Regulatory Changes and Evaluating Their Current and Anticipated Impact on Clinical Operations and GCP Compliance Michael R. Hamrell, Ph.D., RAC, FRAPS, RQAP-GCP, CCRA, President, MORIAH CONSULTANTSCeleste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP, Principal Specialist, Clinical Quality Assurance, BOSTON SCIENTIFIC Michele Weitz, Director, GCP Compliance Operations, CLOVIS ONCOLOGY, INC. › Navigating the impact of these changing regulations
- Assessing the current effect on operations and compliance - Analyzing the intended impact and comparing to predictions
› Evaluating what actions should be taken to account for new developments - Setting a timeline for change implementation to remain
compliant - Determining which processes and people are most effected - Communicating the importance of these changes to internal
parties - Discussing where most companies are with implementing these
operational and compliance changes
4:30 Seminar Concludes
THE CHANGING GCP REGULATORY ENVIRONMENT
Full-Day Seminar Continued
THE CHANGING GCP REGULATORY ENVIRONMENT
FULL-DAY INTERACTIVE SEMINAR HALF-DAY WORKSHOPS7:45 Registration and Continental Breakfast8:30
Examining Common Trial Master File (TMF) Inspection Findings and Leveraging Metrics to Ensure an Inspection-Ready TMFTipsuda Kongtong, MPH, Senior Associate, Clinical Quality Assurance, EISAI INC.Linda B. Sullivan, Co-Founder and President, METRICS CHAMPION CONSORTIUM LLC › Defining the Trial Master File (TMF)› Comparing paper versus electronic TMFs: the good, the bad and the ugly › Examining a case study of an MHRA inspection and the resulting TMF
process changes - Walking through the background and execution of the MHRA inspection - Evaluating the resulting major finding regarding the TMF - Developing a CAPA for programmed TMF audits- Implementing a programmed audit approach - Describing the current state of eTMF audits - Outlining challenges, best practices and lessons learned from the
experience › Gauging the expectations of different regulatory agencies by examining
types and levels of inspection findings related to the TMF › Identifying and leveraging metrics to maintain a healthy TMF
- Mapping the TMF process to be able to track metrics • Establishing who is responsible for inputting data into the TMF
and when - Determining basic metrics related to the TMF that should be tracked
• Linking metrics to certain milestones within the study- Outlining which additional metrics are valuable when utilizing an eTMF
12:00 Workshop A Concludes and Lunch for Workshop A Participants
12:30 Registration for Workshop B Participants1:00
Developing a Standardized and Streamlined Approach to Technical Service Provider Prequalification that Improves Quality and Reduces Risk Janis Hall, MBA, C.O.P., Senior Consultant, THE AVOCA GROUP Scott A. Harris, Head, Third Parties Quality Management, SANOFI Dawn M. Niccum, BSN, M.S., RN, PMP, CCRA, Associate Director, Quality, ENDOCYTEDennis Salotti, M.S., MBA, CCRA, Vice President, Operations, THE AVOCA GROUP › Assessing the challenges in the prequalification process for technical
service providers (TSPs)- Outlining current industry dysfunction with regard to TSP
prequalification - Discussing solutions to current prequalification challenge areas
› Outlining the design and development of the Avoca Quality Consortium standardized toolset for prequalifying TSPs - Walking though the elements of the toolset through interactive case
studies - Responding to pre-populated mock provider responses to the RFI
tool, and working through TSP prequalification process using the tools and data provided
› Evaluating the implications of centralized and standardized approaches on sponsors, providers and regulatory authorities
› Identifying opportunities for optimizing quality, efficiency and confidence with better prequalification procedures
4:30 Workshop B Concludes
WORKSHOP A: TRIAL MASTER FILES
WORKSHOP B: VENDOR PREQUALIFICIATION
9%VPs/SVPs/EVPs
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Tuesday, October 18, 2016 Main Conference Day One
7:45 Registration and Continental Breakfast
8:30 CHAIRPERSON’S WELCOME AND INDUSTRY UPDATE Kathy Goin, Vice President, Clinical Operations, TREVENA, INC.
9:00 THE CHANGING LANDSCAPE OF CLINICAL QUALITY AND COMPLIANCE: ARE WE AT A TIPPING POINT?
Conceptualizing the Future State of Clinical Quality and Compliance and Evaluating the Impact on TodayModerator:Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP, Principal Specialist, Clinical Quality Assurance, BOSTON SCIENTIFIC Panelists:Michael R. Hamrell, Ph.D., RAC, FRAPS, RQAP-GCP, CCRA, President, MORIAH CONSULTANTSSunil Kotecha, Director, Regulatory Inspection Management, PFIZER Cheryl McCarthy, RQAP-GCP, CQA, CBA, Associate Director, R&D Quality and Compliance, BIOGEN Ann Meeker-O’Connell, Head, BioResearch Quality and Compliance, JOHNSON & JOHNSON Steve Whittaker, Senior Consultant, THE AVOCA GROUP; Executive Director, THE AVOCA QUALITY CONSORTIUM› Outlining current compliance needs and wants from
sponsors and CROs, and anticipating what their future needs and wants are likely to be
› Evaluating the impact of global regulatory changes on clinical quality and compliance- How do the new ICH E6 mandates impact vendor
oversight? › Examining the changing landscape of regulatory inspections
and the future of inspection management› Exploring the developing roles of auditing and quality/
compliance, and how these roles will evolve› Addressing compliance at the patient level and the future of
informed consent - Examining compliance concerns regarding wearables,
injestables and other trends› Defining data management needs and how they will
continue to change › Identifying what metrics will and will not be meaningful as
the compliance and regulatory landscape evolves › Discussing what shifts in variables mean for clinical
compliance and quality today
10:30 Networking and Refreshment Break
11:00 PANEL DISCUSSION: VENDOR OVERSIGHT WITHIN DIFFERENT OUTSOURCING MODELS
Examining the Challenges and Best Practices for Conducting Clinical Quality Oversight of Vendors Under Different Partnership Models Panelists:Angela Berns, Director and Head of Vendor Management, Clinical Quality Assurance, UCB BIOSCIENCES, INC. Deirdre Hall, M.S., Head, Vendor Quality Management, Clinical Development Quality (CDQ), PFIZER Samantha A. Vaccaro, MPH, Senior Clinical Trial Manager, ULTRAGENYX PHARMACEUTICAL INC.
› Comparing and contrasting the basics of the strategic partner, preferred provider and functional service provider models
› Detailing the challenges to oversight within each of these models - Outlining specific case studies of issues and how they
were overcome - Identifying key pieces of advice and guidance to optimize
oversight within these models › Approaching oversight challenges when working globally
within these models › Predicting what outsourcing partnerships will look like 20
years from now
12:00 HARMONIZING SOPs Developing Harmonized SOPs and Global Quality
Standards Based on a Process Gap Analysis Across All Vendors in Support of Sponsor Clinical ProgramsJohn Arditi, Executive Consultant, PHARMA COMPLIANCE CONSULTING Lynn Sutton, Vice President Clinical Operations, INSEPTION GROUP, LLC› Examining the benefits of aligned SOPs that increase
efficiencies and quality while reducing risk › Conducting a gap analysis to develop harmonized SOPs that
include sponsor and all outsourced vendors › Achieving greater efficiencies through streamlined
processes and continuous process improvement› Reducing risk through proactive process intervention of
potential problem areas› Focusing the sponsor/CRO alliance on comprehensive and
seamless global quality
12:45 Lunch
1:45 INTERACTIVE SESSION: ACHIEVING A CONFIDENT STATE OF INSPECTION READINESS
Developing Effective Strategies to Ensure Your Vendors and Sites Are Inspection ReadyFacilitators: Matthew Krumrai, Associate Director, Clinical QA, ABBVIE Michele Weitz, Director, GCP Compliance Operations, CLOVIS ONCOLOGY, INC.› Discussing the critical components of an inspection
readiness plan for vendors and sites - Understanding which areas of a plan are of highest
importance and require the most review › Defining the role of the sponsor and the CRO during an
inspection › Utilizing audits and mock inspections to verify inspection
readiness state › Examining training and preparation strategies when faced
with staff turnover › Analyzing what inspections will look like five, 10 and even
25 years from now › Engaging with the audience to share their experiences, best
practices and challenges
3:00 Networking and Refreshment Break
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“The conference and speakers were all excellent. This was a very valuable conference and input from the participants will improve our quality oversight of vendors.”
—Brandy Schenck, Auditor, Quality Assurance, Infinity Pharmaceuticals
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Tuesday, October 18, 2016 Main Conference Day One
3:30 PANEL DISCUSSION: QUALITY MANAGEMENT SYSTEMS
Leveraging a Quality Management System (QMS) to Oversee Clinical Partners and Mitigate Risk Panelists: Tammy Clark, Director, Clinical Development Quality, PFIZERKaren Conway, Associate Director, Clinical Quality Assurance, MARATHON PHARMACEUTICALS Calvin H. Kim, Senior GxP IT Auditor, R&D Quality, BAYER
8:00 Continental Breakfast
8:30 CHAIRPERSON’S OPENING AND RECAP OF PREVIOUS DAYKathy Goin, Vice President, Clinical Operations, TREVENA, INC.
8:45 PFIZER CASE STUDY: VENDOR GCP QUALITY RISK MANAGEMENT FRAMEWORK
Developing a GCP Quality Risk Management Framework for Managing Risk in Vendor Engagements Deirdre Hall, M.S., Head, Vendor Quality Management, Clinical Development Quality (CDQ), PFIZER › Evaluating the need for the framework and the anticipated
outcome › Navigating the framework principles, critical-to-success
factors and barriers to implementation› Adapting vendor oversight for different risk levels › Integrating the vendor GCP quality risk management
framework into the QMS
9:30 PANEL DISCUSSION: RISK-BASED AUDITING Discussing the Pros and Cons of Varying Vendor
Auditing Strategies that Effectively Assess Risk and Optimize Resources Panelists:Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP, Principal Specialist, Clinical Quality Assurance, BOSTON SCIENTIFIC Cheri Wilczek, President, CLINAUDITS, LLCADDITIONAL PANELISTS TBD› Evaluating the different risk-based auditing approaches
used by panelists for vendors › Sharing effective tools and valuable case study examples
- How do you assess risk and determine an audit is needed?- Are you executing remote audits?
› Outlining when a risk-based auditing approach may NOT make the most sense
› Analyzing lessons learned and best practices from risk-based auditing experiences
10:30 Networking and Refreshment Break
Wednesday, October 19, 2016 Main Conference Day Two
› Defining what QMS means to you and within your company› Determining whether there is a need for industry
standardization regarding clinical QMS› Implementing a top-down approach when developing a QMS › Mitigating and troubleshooting data integrity issues and
identifying common problem areas › Addressing nonconformance and CAPA management as
part of the QMS› Utilizing the QMS to ensure quality and leveraging the QMS
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4:30 ROUNDTABLE DISCUSSIONS Each conference participant selects one topic from the following list to discuss in an intimate setting.
1. RESOURCE OPTIMIZATION AT SMALL COMPANIES: Evaluating Resource Issues and Operational Concerns Unique to Smaller Companies
2. INFORMED CONSENT: Discussing GCP Requirements and the Idea of Electronic Informed Consent
3. QUALITY OVERSIGHT OF LATE PHASE RESEARCH: Developing a Quality Oversight and Compliance Strategy for Registries and Late Phase Studies
4. EDUCATION AND TRAINING: Examining the Evolving Training and Education Needs and Developing an Effective Risk-Based Strategy
5. QUALITY BY DESIGN: Recognizing the Trial Protocol as a Critical Quality Management Tool
6. CLINICAL CAPAs: Examining Proper Development and Execution of Corrective and Preventive Actions (CAPAs)
7. QUALITY AGREEMENTS: Evaluating the Use and Effectiveness of Quality Agreements with Clinical Vendors
8. WAYS TO PREPARE FOR CHANGE: Managing Staff Turnover, M&As, and Other Abrupt and Unanticipated Changes that Impact Clinical Quality and Compliance
5:15 Day Concludes
9. RESPONSIBLE PARTIES FOR ENSURING CLINICAL COMPLIANCE AND QUALITY: Discussing Clinical Compliance and Quality Management Responsibilities Among Internal Teams
10. GLOBAL INSPECTION PREPARATION: Comparing Inspections from Different Agencies to Know How to Be Prepared and Manage Expectations
11. DATA QUALITY OPTIMIZATION: Ensuring Data Integrity When Executing Risk-Based Management and Oversight Approaches
12. EFFECTIVE INDICATORS OF VENDOR PERFORMANCE: Measuring the Performance of Vendors Utilizing Key Predictive and Ongoing Indicators to Mitigate Risk and Optimize Compliance
13. TRIAL MASTER FILE (TMF): Working with Partners to Maintain a Compliant and Complete TMF and Leveraging the TMF as an Oversight Tool
14. STREAMLINING INTERNAL OPERATIONS: Defining the Roles of QA and Clinical Teams and Recognizing When Collaboration is Productive or Independence Must be Maintained
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TRACK A TRACK BTAKEDA CASE STUDY: JANSSEN CASE STUDY:
11:00
Examining the Foundation Principals of Vendor Oversight that Produce QualitySarah Jane Constantine, Associate Director, Clinical Operations, TAKEDA PHARMACEUTICALS INTERNATIONAL CO. › Defining vendor oversight within the strategic partnership
model › Leveraging effective vendor oversight to identify and resolve
study issues › Outlining workable pathways of escalation that result in
improved performance
Recognizing the Benefits of a Culture of Quality and Strategies for ImplementationKrista Kerr, Associate Director, Team Lead Americas, R&D Quality and Compliance, JANSSEN › Defining the culture of quality at your company › Describing the benefits of this foundation › Assessing the impact of the culture on vendors and sites› Gaining corporate buy-in for building this foundation › Examining implementation hurdles and how they were
overcomeUCB CASE STUDY: LILLY CASE STUDY:
11:45
Developing and Implementing an Effective Communication Governance Structure and Collaborative PartnershipAngela Berns, Director and Head of Vendor Management, Clinical Quality Assurance, UCB BIOSCIENCES, INC. › Building a culture internally and with your vendors based on
transparency and acceptance, not fear and blame - Cultivating a partnership where all possible issues are
brought to the table early, not hidden › Establishing formalized steering committees and
cross-functional teams that work together to oversee partnerships and identify, discuss, escalate and resolve issues
› Predefining a detailed escalation process and identifying points of contact should an issue arise
Examining the Drivers, Development and Implementation of a Proactive Inspection Readiness ApproachNathalie Riebel, Director, Medical Quality – Oncology, ELI LILLY› Outlining the original approach for inspection readiness › Reviewing the past three-year inspection schedule from
varying regulatory authorities and outlining the related challenges
› Examining the shortfalls of the original inspection readiness approach
› Revamping the inspection readiness plan to be more proactive and better ensure inspection readiness
› Discussing implementation hurdles and results to date of the new approach
12:30 Lunch
1:30 DOCUMENTING VENDOR OVERSIGHT Effectively Documenting the Oversight Process to
Ensure Inspection Readiness › Knowing what processes and actions should be
documented to demonstrate that you are conducting effective oversight
› Explaining how to record oversight processes and actions› Integrating the appropriate documentation actions into your
oversight processes from the start of the trial so you are always inspection ready
› Utilizing tools to visualize the documentation and ensure compliance
2:15 PANEL DISCUSSION: WHAT HAPPENED TO SIMPLE RISK-BASED MONITORING?
Is Today’s Complex and Growing RBM Model Really What the Initial Regulations Intended It to Be? Panelists:Patricia Green-Amsler, CCRC, CCRA, Director, Clinical Compliance, INOVIO PHARMACEUTICALS, INC.Dan Walsh, Director, Clinical Oversight, MYLAN ADDITIONAL PANELISTS TBD
› Discussing the initial drivers for RBM and the anticipated outcome
› Comparing that outcome to the complex, systemic process revamp into which RBM has evolved - Is this what the FDA intended? Did they want us to be
looking at all these signals and noise? - Does the complexity lie in the RBM process or the
change management that is necessary for effective implementation?
- Have we as an industry gone too far?› Evaluating whether it is possible to execute RBM on a basic
and simple level in the present environment
3:15 CHAIRPERSON’S CONCLUDING REMARKSKathy Goin, Vice President, Clinical Operations, TREVENA, INC.
3:30 Close of Conference
Wednesday, October 19, 2016 Main Conference Day Two
VENDOR OVERSIGHT IMPLEMENTATION
CASE STUDIES
COMMUNICATION GOVERNANCE
BUILDING A QUALITY CULTURE
PROACTIVE INSPECTION READINESS APPROACH
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Demonstrate your industry expertise as a service provider by presenting a session or joining a panel discussion.
For more information contact Alex Siegel at 917-242-3893 or [email protected].
www.exlevents.com/CQOF 7
Questions? Comments? • Do you have questions or comments on the agenda? • Is there a specific topic missing that you would like to
see addressed? • Would you like to get involved as a speaker, panelist or
roundtable moderator?
Please contact Event Director Kristen Hunter at 212-400-6241 or [email protected]. She’d be happy to discuss any of the above with you, or any other questions that you have about this program.
Registration Fees for Attending ExL’s 7th Clinical Quality Oversight Forum:
Early Bird Pricing – Register by September 9, 2016 Conference and Full-Day Seminar . . . . . . . $2,395 Conference and Two Workshops . . . . . . . . $2,395 Conference and One Workshop . . . . . . . . . $2,095Conference Only. . . . . . . . . . . . . . . . . . . . . . $1,795
Standard Pricing – Register After September 9, 2016 Conference and Full-Day Seminar . . . . . . . $2,595 Conference and Two Workshops . . . . . . . . $2,595 Conference and One Workshop . . . . . . . . . $2,295Conference Only. . . . . . . . . . . . . . . . . . . . . . $1,995
Onsite Pricing Conference and Full-Day Seminar . . . . . . . $2,695 Conference and Two Workshops . . . . . . . . $2,695 Conference and One Workshop . . . . . . . . . $2,395Conference Only. . . . . . . . . . . . . . . . . . . . . . $2,095
To inquire about full-time academic and government rates, call 866-207-6528.
GROUP DISCOUNT PROGRAMDiscount offers may not be combined. Early bird rates do not apply. To find out more about how you can take advantage of these group discounts, please call 866-207-6528.
Save 25% Per Person when Registering Four For every three simultaneous registrations from your company, you will receive a fourth complimentary registration to the program (must register four at one time). This is a savings of 25% per person.
Save 15% Per Person when Registering Three Can only send three? You can still save 15% off of every registration.
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ExL Events, Inc.Mail: 494 8th Avenue, 4th Floor New York, NY 10001
Phone: 866-207-6528
Online: www.exlevents.com/cqof
Email: [email protected]
Fax: 888-221-6750
Five Ways to Register:Method of Payment: q Check q Credit Card
Make checks payable to: ExL Events, Inc.
Card Type: q MasterCard q Visa q Discover q AMEX
Card Number: _________________________________________________________
Exp. Date:_______________________________ CVV:__________________________
Name on Card: _______________________________________________________________
Signature: ____________________________________________________________________
Please contact me:
q I’m interested in marketing opportunities at this event.
q I wish to receive email updates on ExL Pharma’s upcoming events.
CONFERENCE CODE: C827q Yes! Register me for the conference and full-day seminar.
q Yes! Register me for the conference and both workshops.
q Yes! Register me for the conference and TMF workshop.
q Yes! Register me for the conference and vendor prequalification workshop.
q Yes! Register me for the conference only.
Name:____________________________________________ Title:__________________
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Clinical Quality Oversight Forum7t
h An
nual
October 17-19, 2016 | Hilton Philadelphia at Penn’s Landing | Philadelphia, PA
www.exlevents.com/CQOF
Sponsors and Exhibitors#CQOF
Proactive GCP Compliance
Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRPBOSTON SCIENTIFIC
Michael R. Hamrell, Ph.D., RAC, FRAPS, RQAP-GCP, CCRA, MORIAH CONSULTANTS
Sunil KotechaPFIZER
Cheryl McCarthy, RQAP-GCP, CQA, CBA,BIOGEN
Steve WhittakerTHE AVOCA GROUP; THE AVOCA QUALITY CONSORTIUM
Ann Meeker-O’ConnellJOHNSON & JOHNSON
MODERATOR SPEAKERS
Association Partners
Ensuring Trial Integrity by Effectively Assessing, Optimizing and Managing the Quality of Clinical Vendors and Sites
Visionary Leaders Weigh in on the Changing Landscape of Clinical Quality and Compliance: ARE WE AT A TIPPING POINT?