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Clinical Quality Oversight Forum7t

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October 17-19, 2016 | Hilton Philadelphia at Penn’s Landing | Philadelphia, PA

Sponsors and Exhibitors

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

Ellen Kelso, Executive Director, Strategic Development, CHESAPEAKE IRB

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

#CQOFProactive 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 asiegel@exlevents.com.

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 Directorkhunter@exlevents.com 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 affected - 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 WORKSHOPS

7:45 Registration and Continental Breakfast8:30

Examining Common Trial Master File (TMF) Inspection Findings and Leveraging Metrics to Ensure an Inspection-Ready TMFLinda 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, Clinical External 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 CONSULTANTSEllen Kelso, Executive Director, Strategic Development, CHESAPEAKE IRB Sunil 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.

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Tuesday, October 18, 2016 Main Conference Day One

› 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

2:45 CASE STUDY: LEVERAGING RBM TO ACHIEVE COMPLIANCE

Examining the Journey from Early Interpretation of Incoming ICH Guidelines through to Full Compliance and the Role of Risk-Based Monitoring (RBM)Duncan Hall, Chief Executive Officer, TRIUMPH RESEARCH INTELLIGENCESarah Blondell, Vice President, Clinical Services, TMC PHARMA Gareth Ridge, Director, Clinical Services, TMC PHARMA › Evaluating the internal, regulatory and customer drivers

that initiated the process › Defining what RBM means to TMC’s customers and

what it means to TMC › Developing the RBM maturity model to outline what ‘fit

for purpose’ looks like for a SME product development organization

› Structuring an implementation roadmap that ensures a pragmatic and cost effective solution

› Assessing how quality management and RBM fit into the clinical development process and impact timelines

› Discussing the end result for TMC and how this is helping future proof their business and that of their customers

3:30 Networking and Refreshment Break

4:00 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› 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 as an oversight tool

4:45 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

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

5:30 Day Concludes

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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

overcome

Wednesday, October 19, 2016 Main Conference Day Two

VENDOR OVERSIGHT IMPLEMENTATION CASE STUDIES

BUILDING A QUALITY CULTURE

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 BreakPA

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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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TRACK A TRACK BUCB 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 INTERACTIVE POLLING SESSION: QUALITY UNIT ORGANIZATION

Comparing How the Clinical Quality Unit is Organized within the Functional Structure of the Company Crystal Mersh, Executive Partner, QUALITY EXECUTIVE PARTNERS INC.› Examining how different companies define the role and

responsibilities of the clinical quality unit› Identifying the variations in how the clinical quality unit

aligns and interacts with the other department units› Benchmarking the expected outputs of the clinical

quality unit› Assessing satisfaction with the efficiency of the

current structure

2:00 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

3:00 CHAIRPERSON’S CONCLUDING REMARKSKathy Goin, Vice President, Clinical Operations, TREVENA, INC.

3:15 Close of Conference

Wednesday, October 19, 2016 Main Conference Day Two

CASE STUDIES

CASE STUDIES

COMMUNICATION GOVERNANCE 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 asiegel@exlevents.com.

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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 khunter@exlevents.com. 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.

TERMS AND CONDITIONS: By registering for an ExL Events, Inc. (“ExL”) event, you agree to the following set of terms and conditions listed below: REGISTRATION FEE: The fee includes the conference‚ all program materials‚ and designated continental breakfasts‚ lunches and refreshments. PAYMENT: Make checks payable to ExL Events, Inc. and write C827 on your check. You may also use Visa, MasterCard, Discover or American Express. Payments must be received in full by the conference date. Any discount applied cannot be combined with any other offer and must be paid in full at the time of order. Parties must be employed by the same organization and register simultaneously to realize group discount pricing options. **Please Note: There will be an administrative charge of $300 to substitute, exchange and/or replace attendance badges with a colleague within five business days of any ExL conference.** CANCELLATION AND REFUND POLICY: If you cancel your registration for an upcoming ExL event, the following policies apply, derived from the Start Date of the event: • Four weeks or more: A full refund (minus a $295 processing

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ExL Events, Inc. does not and is not obligated to provide a credit voucher to registered attendee(s) who do not attend the event they registered for unless written notice of intent to cancel is received and confirmed prior to the commencement of the event. SUBSTITUTION CHARGES: There will be an administrative charge of $300 to substitute, exchange and/or replace attendee badges with a colleague occurring within five business days of the conference. ExL Events reserves the right to cancel any conference it deems necessary and will not be responsible for airfare‚ hotel or any other expenses incurred by registrants. ExL Events’ liability is limited to the conference registration fee in the event of a cancellation and does not include changes in program date‚ content‚ speakers and/or venue. *The opinions of ExL’s conference speakers do not necessarily reflect those of the companies they represent, nor ExL Events, Inc. Please Note: Speakers and agenda are subject to change without notice. In the event of a speaker cancellation, significant effort to find a suitable replacement will be made. The content in ExL slide presentations, including news, data, advertisements and other information, is provided by ExL’s designated speakers and is designed for informational purposes for its attendees. It is NOT INTENDED for purposes of copywriting or redistribution to other outlets without the express written permission of ExL’s designated speaking parties. Neither ExL nor its content providers and/or speakers and attendees shall be liable for any errors, inaccuracies or delays in content, or for any actions taken in reliance thereon. EXL EVENTS, INC. EXPRESSLY DISCLAIMS ALL WARRANTIES, EXPRESSED OR IMPLIED, AS TO THE ACCURACY OF ANY CONTENT PROVIDED, OR AS TO THE FITNESS OF THE INFORMATION FOR ANY PURPOSE. Although ExL makes reasonable efforts to obtain reliable content from third parties, ExL does not guarantee the accuracy of, or endorse the views or opinions given by any third-party content provider. ExL presentations may point to other websites that may be of interest to you, however ExL does not endorse or take responsibility for the content on such other sites.

Fax: 888-221-6750Five Ways to Register:

Email: registration@exlevents.com

Online: www.exlevents.com/cqofPhone: 866-207-6528 Mail: ExL Events, Inc.494 8th Ave, 4th FloorNew York, NY 10001

Registration Information

Venue Hilton Philadelphia at Penn’s Landing201 South Columbus Blvd.Philadelphia, PA 19106If you require overnight accommodations please contact the hotel. ExL has reserved a room block at a group rate for ExL participants. To make reservations guests can call 1-800-HILTONS (8667) and request the group rate for “ExL’s October Meetings.”The group rate is available until September 27, 2016. Please book your room early as rooms available at this rate are limited.

*ExL Events, Inc. is not affiliated with Exhibition Housing Management (EHM)/Exhibitors Housing Services (EHS) or any third-party booking agencies, housing bureaus, or travel and events companies. In the event that an outside party contacts you for any type of hotel or travel arrangements, please disregard these solicitations and kindly email us at info@exlevents.com. ExL has not authorized these companies to contact you and we do not verify the legitimacy of the services or rates offered. Please book your guest rooms through ExL’s reserved guest room block using the details provided.

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Registration Information

ExL Events, Inc.Mail: 494 8th Avenue, 4th Floor New York, NY 10001

Phone: 866-207-6528

Online: www.exlevents.com/cqof

Email: registration@exlevents.com

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:__________________

Company:________________________________________________________________

Dept.:_____________________________________________________________________

Address:__________________________________________________________________

City:_____________________________________________ State:______ Zip:_________

Email:____________________________________________________________________

Phone:_________________________________ Fax:______________________________

Clinical Quality Oversight Forum7t

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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

Ellen Kelso, CHESAPEAKE IRB

Cheryl McCarthy, RQAP-GCP, CQA, CBA,BIOGEN

Steve WhittakerTHE AVOCA GROUP; THE AVOCA QUALITY CONSORTIUM

Ann Meeker-O’ConnellJOHNSON & JOHNSON

MODERATOR SPEAKERS

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?