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October 10-12, 2018 | Sonesta Hotel Philadelphia | Philadelphia, PA

Ensuring Trial Integrity by Effectively Assessing, Optimizing and Managing the Quality of Clinical Vendors and Sites

FEATURED SESSIONS

Sponsors and Exhibitors

Angela Berns,Director and Head of Vendor Management, UCB BIOSCIENCES INC.

CONFERENCE CHAIR

THREE INTERACTIVE WORKSHOPS ON OCTOBER 10

BREAKFAST WORKSHOPCRO Oversight Post ICH E6 R2

LUNCH WORKSHOPMitigating Risk at the Site Level

DINNER WORKSHOPQuality Tolerance Limits

Consortium Partner Supporting Partner

CASE STUDY: INTERNAL COMMUNICATION OPTIMIZATIONOptimizing Oversight Through Effective Communication Between Clinical Quality and Clinical Operations

Christina Salerno, Executive Director, Head, Clinical Sciences and Study Management, Primary Care, Interim

Head, HQ Clinical Quality Management, MERCK

Karine Julien, Executive Director, Therapeutic Area Head, Primary Care, and Interim Pharmacovigilance Head, MRL Quality Assurance, MERCK

REAL CASE STUDIES OF AVOIDABLE FAILURES Examining Fundamental Failures by Top CROs Identified Through Audits and How Effective Oversight Would Have Prevented Them Sharon Reinhard, M.S., Clinical Compliance Solutions, Consultant on Assignment, MERCK

CASE STUDY: QUALITY TOLERANCE LIMITS Exploring the Path From Definition to Implementation of Quality Tolerance Limits at Pfizer Melissa Suprin, Head, Clinical Quality Risk Management, PFIZER

CASE STUDY: QUALITY AGREEMENTSUnderstanding the Purpose and Value of Quality Agreements and Outlining the Essential Elements JoAnna Brodie, Director, Clinical Quality Assurance — Third-Party Resourcing, GLAXOSMITHKLINE

FDA PERSPECTIVEUnderstanding Center for Drug Evaluation and Research (CDER) Bioresearch Monitoring (BIMO) Compliance and Enforcement Miah Jung, Pharm.D., M.S., Pharmacologist, Office of Scientific Investigations, Office of Compliance, CENTER FOR DRUG EVALUATION AND RESEARCH (CDER), FDA

PanelistsModeratorSENIOR LEADERS PANEL: PRIORITIZING QUALITY Driving Quality From the Top-Down to Build a Successful Quality Culture

Kira Drummond, Head, R&D Quality and Compliance, ALEXION PHARMACEUTICALS, INC.

Paul Houri, Vice President, Head of BioResearch Quality Assurance, JOHNSON & JOHNSON

Melissa Mudrick, Vice President and Global Head, R&D Quality and Compliance, BIOGEN

Greg Dombal, Chief Operating Officer, HALLORAN CONSULTING GROUP

#CQOF

Proactive GCP Compliance

Stay Connected

To register, call 866-207-6528 or visit www.exlevents.com/CQOF

To register, call 866-207-6528 or visit www.exlevents.com/CQOF

Who Should Attend?The 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/Auditor • 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

Dear Colleague

The CQOF has become THE annual event for clinical quality professionals to network with, learn from and benchmark against their peers. The CQOF provides an interactive forum for senior-level clinical quality and operations professionals to engage, discuss and share their challenges, best practices and experiences in developing effective clinical quality oversight strategies that incorporate risk-based approaches to ensure their vendors and sites are compliant and inspection ready. Participants leave with practical tools and knowledge to optimize their oversight efforts and mitigate risks in their clinical trials.

I look forward to seeing you in October. Please don’t hesitate to reach out with any questions. Sincerely,

Kristen HunterKristen Hunter Event Director khunter@exlevents.com 212-400-6241

2017 Audience Profile

10% CROs

38% Small Pharma, Biotech

or Device Companies

5% Other

70% Pharma, Biotech and

Device Companies

28% Large Pharma, Biotech

or Device Companies

15% Non-CRO Clinical Service Providers 34%

Mid-Sized Pharma, Biotech or Device Companies

Sponsorship and Exhibition Opportunities

Do you want to spread the word about your organization’s solutions to potential clients and prospects in attendance? Take advantage of the opportunity to exhibit, present an educational session, share your expertise on a panel discussion, moderate a roundtable, 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 Arthur Butler at 917-932-0429 or abutler@exlevents.com.

To make reservations, guests can call 1-800-SONESTA and request the group rate for ExL’s October Meetings or visit https://bit.ly/2GLe6ig.

The group rate is available until September 18, 2018. Please book your room early, as rooms available at this rate are limited.

*ExL Events is not affiliated with Exhibition Housing Management (EHM)/Exhibitors Housing Services (EHS) or any third-party booking agencies, housing bureaus or travel companies. ExL Events is affiliated with event company Questex, LLC. 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.

Venue

Sonesta Hotel Philadelphia 1800 Market St. / Philadelphia, PA 19103

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.

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Company Type

Company Size of Trial Sponsors

To register, call 866-207-6528 or visit www.exlevents.com/CQOF

7:30 Registration and Continental Breakfast

8:15 BREAKFAST WORKSHOP: CRO OVERSIGHT POST ICH E6 R2 Examining the Impact of ICH E6 R2 on CRO Oversight and Ensuring Compliance

Liz Wool, President, WOOL CONSULTING GROUP, INC.• Evaluating ICH E6 R2 and identifying the requirements for sponsors and CROs related to the oversight of outsourced clinical trial activities, tasks, etc.

Understanding what specific elements of R2 impact oversight Interpreting the oversight expectations and comparing them to select regulatory authorities Discussing responsibilities for the oversight of subcontractors

• Assessing adherence to ICH E6 R2 requirements and identifying any gaps Appraising your current CRO-Vendor oversight practices Conducting a gap analysis to identify areas of noncompliance Discussing methodologies for R2 adherence

• Designing/Redesigning your oversight program or compliance Walking through the critical elements of an ICH E6 R2 compliant oversight program Translating results from the gap analysis into actions Examining strategies for maintaining an effective and compliant oversight program

9:45 15-Minute Break

10:00 Breakfast Workshop Continues

11:30 Breakfast Workshop Concludes/Registration for Lunch Workshop

12:00 LUNCH WORKSHOP: MITIGATING RISK AT THE SITE LEVEL Examining Common Challenges and Obstacles From the Site’s Perspective and

Proactive Approaches the Trial Sponsor/CRO Can Take to Avoid Them Beth Harper, President, CLINICAL PERFORMANCE PARTNERS, INC.• Assessing the protocol

Understanding common risk areas for sites from the protocol Conducting protocol feasibility and optimization assessments Evaluating varying protocol optimization strategies and tools Helping sites translate the protocol into practice through effective study implementation strategies

• Training optimization Discussing where most sites lack training and the issues that result Evaluating different approaches to training and understanding what works and what doesn’t from the site’s perspective Customizing training programs for maximum impact

• Proactive approaches Identifying simple things sponsors/CROs can do to optimize site performance and mitigate risk

12:45 45-Minute Break for Lunch

1:30 Lunch Workshop Continues

3:45 Lunch Workshop Concludes/Registration for Dinner Workshop

4:30 DINNER WORKSHOP: QUALITY TOLERANCE LIMITS Understanding the Methodology for Establishing and Maintaining Appropriate Quality Tolerance Limits (QTLs)

Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP, Principal Specialist, Clinical Quality Assurance, BOSTON SCIENTIFIC • Develop

Defining QTLs and understanding their purpose Evaluating the requirements driving the development of QTLs Examining the protocol to identify the critical processes and at what stages human subject protection and/or data integrity could be impacted Examining proposed study sites to identify processes and patient flow and at what points protocol implementation could be impacted Documenting the development process

• Apply Implementing the established QTLs Tracking and assessing the data to establish whether they are within the tolerance limits Responding when things move beyond the established thresholds

• Adjust Recognizing that QTLs evolve over time and can be ramped up or ramped down depending on the circumstances Evaluating the situation to determine if the QTLs need to be adjusted Documenting to justify any changes in the QTLs

6:00 60-Minute Break for Dinner

7:00 Dinner Workshop Continues

8:30 Dinner Workshop Concludes

Wednesday, October 10, 2018 Workshop Day

To register, call 866-207-6528 or visit www.exlevents.com/CQOF

Thursday, October 11, 2018 Main Conference

7:45 Registration and Continental Breakfast

8:30 CHAIRPERSON’S WELCOME AND INDUSTRY UPDATE

Angela Berns, Director and Head of Vendor Management, Clinical Quality Assurance, UCB BIOSCIENCES INC.

9:00 INDUSTRY SURVEY RESULTS: CRO OVERSIGHT EFFECTIVENESS AND IMPACT

Benchmarking and Understanding the Industry’s CRO Oversight Practices, Their Impact and Effectiveness With New Industry Research Results Beth Harper, President, CLINICAL PERFORMANCE PARTNERS, INC.Michael Wilkinson, Senior Research Analyst, TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT• Analyzing the types of CRO oversight models used for a

variety of outsourcing approaches • Identifying common oversight challenges and areas for

improvement • Determining the effectiveness of various oversight processes,

including management structures, performance metrics monitoring and more

10:00 Networking and Refreshment Break

10:30 SENIOR LEADERS PANEL: PRIORITIZING QUALITY Driving Quality From the Top Down to Build a

Successful Quality Culture ModeratorGreg Dombal, Chief Operating Officer, HALLORAN CONSULTING GROUP Panelists Kira Drummond, Head, R&D Quality and Compliance, ALEXION PHARMACEUTICALS, INC.Paul Houri, Vice President, Head of BioResearch Quality Assurance, JOHNSON & JOHNSONMelissa Mudrick, Vice President and Global Head, R&D Quality and Compliance, BIOGEN • Defining the purpose and goal of a quality culture • Identifying the critical success factors • Examining best practices for initiating the shift from a

reactive issue-based focus to a proactive risk-based focus • Determining the organization’s risk tolerance level • Driving quality as a priority among all stakeholders

11:30 REAL CASE STUDIES OF AVOIDABLE FAILURES

Examining Fundamental Failures by Top CROs Identified Through Audits and How Effective Oversight Would Have Prevented Them Sharon Reinhard, M.S., Clinical Compliance Solutions, Consultant on Assignment, MERCK • Examining detailed accounts of failures in quality standards

in areas of critical impact • Asking the right questions to uncover execution errors in

real time • Discussing how these issues could have been avoided with

effective oversight and performance metrics • Outlining proactive measures to perform in real-time to avoid

retrospective reactions following audits

12:30 Lunch

TRACK A TRACK B1:30 CRITICAL PROCESSES AND DATA IDENTIFICATION

Examining the Protocol to Identify Those Processes and Data That Are Critical and Impact the Oversight Approach Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP, Principal Specialist, Clinical Quality Assurance, BOSTON SCIENTIFIC • Understanding the elements of the protocol that are critical and impact

subject safety and/or data integrity - Breaking down a mock protocol into the critical elements

• Evaluating the risks related to those identified critical processes and data - Identifying risks on both the system and trial levels

• Assessing how these high-risk areas should impact your oversight approach

• Describing how to effectively document this identification process

QUALITY CULTURE IMPLEMENTATION

Executing and Effective Change Management Approach to Build and Sustain a Quality Culture Dawn M. Niccum, M.S., RN, PMP, CCRA, RQAP-GCP, Director, Quality Assurance, INSEPTION GROUP Karin Rezzonico, Associate Director, Clinical Quality Compliance, INSEPTION GROUP• Understanding the importance of change management when it comes to

initiating and sustaining a cultural shift • Examining both the “process” and “human” sides of change and how they

should be addressed • Preparing for change by defining a clear outcome, conducting

assessments to determine the degree of change needed, and identifying change leaders

• Developing a transitional plan to communicate, implement and train • Evaluating the result, addressing gaps and determining next steps for

sustainability

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"The Clinical Quality Oversight Forum in October was EXCELLENT! This was my first time attending an ExL event and I was very happy with my experience. The content was well presented, the presenters were engaging and everything was just so organized and well done. What I liked most was that the level of the content was meant for moderate to highly experienced individuals in QA — it's often hard to find something that isn't just an 'intro to QA.' . I am looking forward to attending more ExL events in the future.”

—Senior Associate, Clinical Quality Assurance, EISAI INC.

To register, call 866-207-6528 or visit www.exlevents.com/CQOF

Thursday, October 11, 2018 Main Conference

2:15 CASE STUDY: QUALITY TOLERANCE LIMITS

Exploring the Path From Definition to Implementation of Quality Tolerance Limits at Pfizer Melissa Suprin, Head, Clinical Quality Risk Management, PFIZER • Defining quality and risk in the quality management system • Establishing risk management fundamentals by identifying,

evaluating and controlling risks• Evaluating the characteristics of the identified risks and the design

of t he trial to determine quality tolerance limits • Meeting ICH E6 R2 requirements by measuring performance,

implementing remediations and including in the CSR• Overseeing and monitoring the performance of QTLs across the trial

portfolio

CASE STUDY: VENDOR AND SITE SELECTION

Identifying a Complementary Quality Culture Among Vendors and Sites to Mitigate Risk Donna-Lee Destouche, M.Sc., CCRP, Senior Clinical Trial Manager, Clinical Development, IMMUNOGEN, INC.• Conceptualizing what you are looking for in a partner and

prioritizing attributes • Evaluating their quality culture to determine if it’s in line with

your own • Determining which predictive metrics matter the most for identifying

potential risk areas • Conducting audits to ensure their quality standards and culture are

in line with your expectations

3:00 Networking and Refreshment Break

3:30 MONITORING POST-R2

Evaluating Systemic Changes to Monitoring That Must Occur As a Result of ICH E6 R2Steve Young, Chief Operations Officer, CLUEPOINTS• Identifying the elements of ICH E6 R2 that relate to monitoring• Evaluating those elements and their impact on monitoring – including

on-site, remote and centralized • Translating those elements into a risk-based methodology for monitoring • Understanding and addressing the perspective of sites with respect to

risk-based monitoring • Assessing the impact of risk-based monitoring on the relationship

between sponsor and CRO

CASE STUDY: QUALITY AGREEMENTS

Understanding the Purpose and Value of Quality Agreements and Outlining the Essential Elements JoAnna Brodie, Director, Clinical Quality Assurance — Third-Party Resourcing, GLAXOSMITHKLINE • Defining the purpose of quality agreements and recognizing

the need • Understanding the differences between the quality agreement, the

contract and other documents and how they should relate • Evaluating who should develop and enforce the quality agreement• Outlining how the quality agreement should be structured and the

essential elements

4:15 ROUNDTABLE DISCUSSIONS

Each conference participant selects one topic from the following list to discuss in an intimate setting.You’ll be asked for your topic selections via email a few weeks out from the conference and will also have the opportunity to sign up on site.

1. CLINICAL STUDY REPORTS (CSRs): Understanding What Should and Should Not Be Included in the CSRs 2. CLINICAL CAPAs: Sharing Best Practices for Defining, Communicating, Tracking and Managing CAPAs 3. WEARABLE DEVICES IN TRIALS: Discussing the Use of Wearables (e.g., Fitbits) to Collect Trial Data and How That Data Is Validated

and Handled During Inspections 4. OVERSIGHT OF THIRD-PARTY CONTRACTORS: Evaluating Regulations and Best Practices for Oversight of Third-Party

Contractors/Vendors Hired by the CRO 5. VIRTUAL TRIALS: Discussing the Quality Issues Related to Virtual Clinical Trials 6. CHINA INSPECTIONS: Sharing Experiences With Inspections in China and How to Prepare 7. TRAINING OPTIMIZATION: Examining Different Training Methodologies and Discussing Their Effectiveness 8. VENDOR AND SITE SELECTION: Identifying a Complementary Quality Culture Among Vendors and Sites to Mitigate Risk 9. KNOWLEDGE MANAGEMENT: Discussing Knowledge Management As a Critical Success Factor for Effective Oversight 10. QUALITY BY DESIGN: Building Quality Into Trial Operations at the Onset to Ensure Quality Is the Priority and Streamline Oversight 11. TRIAL MASTER FILE (TMF): Leveraging the TMF As an Oversight Tool to Ensure Data Integrity and Maintain an Inspection-Ready State12: DOCUMENTING VENDOR OVERSIGHT: Achieving Compliant Documentation of Proper Ongoing Engagement and Evaluation of

Clinical Vendors

5:00 Networking Reception

6:00 Day Concludes

Media Partners

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Friday, October 12, 2018 Main Conference

8:00 Registration and Continental Breakfast

8:30 CHAIRPERSON’S WELCOME AND KEY LEARNING POINTS FROM PREVIOUS DAY

Angela Berns, Director and Head of Vendor Management, UCB BIOSCIENCES INC.

8:45 REGULATORY UPDATE: FDA INSPECTIONS

Understanding Center for Drug Evaluation and Research (CDER) Bioresearch Monitoring (BIMO) Compliance and Enforcement Miah Jung, Pharm.D., M.S., Pharmacologist, Office of Scientific Investigations, Office of Compliance, CENTER FOR DRUG EVALUATION AND RESEARCH (CDER), FDA• Identifying recent trends in CDER-BIMO inspections of clinical

investigators and sponsors• Evaluating what to expect during an inspection and how to

best work with the FDA during the inspection • Describing key strategies for building quality into clinical trials• Discussing approaches for responding to Form FDA 483 and

subsequent regulatory correspondence

9:45 PANEL DISCUSSION: VENDOR AND SITE OVERSIGHT CHANGES AS A RESULT OF ICH E6 R2

Sharing Real-World Case Studies Showing the Actions and Process Adjustments That Resulted From ICH E6 R2 Moderator Frances DeGennaro-Culver, Director, Clinical Research, Headquarters Clinical Quality Management, MERCK Panelists Ryan Jones, CEO, FLORENCE Sheri Kuss, Director, Clinical Quality Lead, PFIZER Cheri Wilczek, President, CLINAUDITS, LLC• Examining how oversight operations were assessed to

determine where adjustments needed to be made to ensure compliance

• Conceptualizing action plans and aligning responsibilities • Evaluating the challenges and obstacles and how they were

overcome • Discussing lessons learned and what could have been

done better

10:45 Networking and Refreshment Break

TRACK A TRACK B11:15 THE IMPACT OF R2 ON SITES

Evaluating the Impact of ICH E6 R2 on Sites and How Sponsors Can Proactively Manage This Change to Optimize Quality Steve Whittaker, Senior Consultant, THE AVOCA GROUP• Examining the elements of ICH E6 R2 that directly impact sites • Recognizing that risk-based monitoring shifts QC from the responsibility

of the Sponsor/CRO to that of the site - Exploring the impact of this shift and how to ensure sites understand their changing role

• Ensuring data quality and integrity at the site level

SITE ACCREDITATION AND STANDARDS INITIATIVE (SASI)

Ensuring Site Quality With the Adoption of a Global Standard and Independent Accreditation Larry Kennedy, Ph.D., Vice President, Quality Management Systems, Chief Quality Officer, ALLIANCE FOR CLINICAL RESEARCH EXCELLENCE AND SAFETY (ACRES); CEO, QUALITY MANAGEMENT INSTITUTE• Understanding the drive to develop this accreditation program• Discussing the purpose of SASI and how it works

- Setting reasonable standards that are above minimal requirements to build an industrywide foundation for quality at the site level - Developing the process for dynamic accreditation - Recognizing and rewarding excellence

• Outlining the specifics of the standards that must be achieved to be accredited

• Evaluating the timeline for piloting and availability

12:00 QUALITY OPTIMIZATION AT THE SITE LEVEL

Comparing the Wants and Needs of the Sponsor/CRO With Those of the Sites to Ensure Quality Is the Priority Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP, Principal Specialist, Clinical Quality Assurance, BOSTON SCIENTIFICSITE REPRESENTATIVE TBD • Examining the protocol and ensuring comprehension by sponsor, CRO and

site through effective training • Identifying the challenges and complexities of the study and modifying

oversight accordingly • Ensuring the CRO and site are equipped to handle the challenges of the

study • Building frequent oversight checks into operations to ensure quality and

compliance

CASE STUDY: INTERNAL COMMUNICATION OPTIMIZATION

Optimizing Oversight Through Effective Communication Between Clinical Quality and Clinical Operations Karine Julien, Executive Director, Therapeutic Area Head, Primary Care, and Interim Pharmacovigilance Head, MRL Quality Assurance, MERCK Christina Salerno, Executive Director, Head, Clinical Sciences and Study Management, Primary Care, Interim Head, HQ Clinical Quality Management, MERCK • Outlining clinical and quality responsibilities• Understanding the importance of having an established

communication plan • Defining a collaborative process to assign accountability and ensure

effective oversight occurs • Evaluating when the two groups should work together and when

independence must be maintained • Detailing realized benefits to oversight through improved internal

collaboration

12:45 Lunch

CASE STUDY

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To register, call 866-207-6528 or visit www.exlevents.com/CQOF

Pricing information for the 9th Clinical Quality Oversight Forum Early Bird Pricing – Register by August 17, 2018All-Access Pass (All sessions, all three days) . . . . . . . . . . . . . . . $2,695Main Conference Only (All sessions on Oct 11–12) . . . . . . . . . . $1,895

– Add Breakfast Workshop on Oct 10 . . . . . . . . . . . . . . . . . . . .$295– Add Lunch Workshop on Oct 10. . . . . . . . . . . . . . . . . . . . . . . .$295– Add Dinner Workshop on Oct 10 . . . . . . . . . . . . . . . . . . . . . . .$395

Standard PricingAll-Access Pass (All sessions, all three days) . . . . . . . . . . . . . . . $2,895Main Conference Only (All sessions on Oct 11–12) . . . . . . . . . . $2,095

– Add Breakfast Workshop on Oct 10 . . . . . . . . . . . . . . . . . . . .$295– Add Lunch Workshop on Oct 10. . . . . . . . . . . . . . . . . . . . . . . .$295– Add Dinner Workshop on Oct 10 . . . . . . . . . . . . . . . . . . . . . . .$395

Onsite PricingAll-Access Pass (All sessions, all three days) . . . . . . . . . . . . . . . $3,095Main Conference Only (All sessions on Oct 11–12) . . . . . . . . . . $2,295

– Add Breakfast Workshop on Oct 10 . . . . . . . . . . . . . . . . . . .$295– Add Lunch Workshop on Oct 10 . . . . . . . . . . . . . . . . . . . . . .$295– Add Dinner Workshop on Oct 10 . . . . . . . . . . . . . . . . . . . . . .$395

*Includes Sales Tax and Service Fees

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1:45 PANEL DISCUSSION: INSPECTION OF OVERSIGHT ACTIVITIES Discussing How Oversight Activities and Processes Were Evaluated During Inspections

Moderator Carol Bognar, QA Consultant, CAROL BOGNAR CONSULTING, INC. Panelists Katie Alberta, Global Head, QA, GLP, GCP, GPvP and PDMA, ALKERMESPriya Chaturvedi, Ph.D., Executive Director, Quality Assurance-Head Vaccines and ID, MERCKSteve Whittaker, Senior Consultant, THE AVOCA GROUP• Sharing panelists’ experiences with inspections related to oversight activities • Understanding what kind of documentation was used to show oversight and how it was received • Discussing expectations related to escalation plans and CAPAs • Resulting procedural changes to oversight as a result of an inspection • Recommendations for being inspection-ready when it comes to demonstrating effective oversight

2:45 CHAIRPERSON’S CONCLUDING REMARKSAngela Berns, Director and Head of Vendor Management, UCB BIOSCIENCES INC.

3:00 Close of Conference

Friday, October 12, 2018 Main Conference

GROUP DISCOUNT PROGRAM* Offers may not be combined. Early Bird rates do not apply.*

For every three simultaneous registrations from your company, you will receive a fourth complimentary registration to the program (must register four). This is a savings of 25% per person.

Can only send three? You can still save 15% off of every registration. To find out more on how you can take advantage of these group discounts, please call 212-400-6240.

SAVE 25%

SAVE 15%

Registration

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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."

— Auditor, Quality Assurance, INFINITY PHARMACEUTICALS

"The conference was a positive open forum that provided an opportunity for sponsors and vendors to come together and share experiences, lessons learned, and identify a path to improve sponsor oversight through better channels of communication."

— Associate Director, Global R&D Quality Assurance, SHIRE PHARMACEUTICALS

To register, call 866-207-6528 or visit www.exlevents.com/CQOF

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October 10-12, 2018 | Sonesta Hotel Philadelphia | Philadelphia, PA

Ensuring Trial Integrity by Effectively Assessing, Optimizing and Managing the Quality of Clinical Vendors and Sites

FEATURED SESSIONS

Angela Berns,Director and Head of Vendor Management, UCB BIOSCIENCES INC.

CONFERENCE CHAIR

THREE INTERACTIVE WORKSHOPS ON OCTOBER 10 BREAKFAST WORKSHOPCRO Oversight Post ICH E6 R2

LUNCH WORKSHOPMitigating Risk at the Site Level

DINNER WORKSHOPQuality Tolerance Limits

REAL CASE STUDIES OF AVOIDABLE FAILURES Examining Fundamental Failures by Top CROs Identified Through Audits, and How Effective Oversight Would Have Prevented Them Sharon Reinhard, M.S., Clinical Compliance Solutions, Consultant on Assignment, MERCK

#CQOF

Proactive GCP Compliance

Stay Connected

Consortium Partner Supporting Partner

PanelistsModeratorSENIOR LEADERS PANEL: PRIORITIZING QUALITY Driving Quality From the Top-Down to Build a Successful Quality Culture

Kira Drummond, Head, R&D Quality and Compliance, ALEXION PHARMACEUTICALS, INC.

Paul Houri, Vice President, Head of BioResearch Quality Assurance, JOHNSON & JOHNSON

Melissa Mudrick, Vice President and Global Head, R&D Quality and Compliance, BIOGEN

Greg Dombal, Chief Operating Officer, HALLORAN CONSULTING GROUP

Sponsors and Exhibitors

FDA PERSPECTIVEUnderstanding Center for Drug Evaluation and Research (CDER) Bioresearch Monitoring (BIMO) Compliance and Enforcement Miah Jung, Pharm.D., M.S., Pharmacologist, Office of Scientific Investigations, Office of Compliance, CENTER FOR DRUG EVALUATION AND RESEARCH (CDER), FDA