Clinical Quality Oversight Forum

Transcription

1 7th Annual October 17-19, 2016 Hilton Philadelphia at Penn s Landing Philadelphia, PA Clinical Quality Oversight Forum MODERATOR 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? SPEAKERS Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP, Principal Specialist, Clinical Quality Assurance, BOSTON SCIENTIFIC FEATURED SESSIONS Matthew Krumrai, Associate Director, Clinical QA, ABBVIE Michael R. Hamrell, Ph.D., RAC, FRAPS, RQAP-GCP, CCRA, President, MORIAH CONSULTANTS Sunil Kotecha, Director, Regulatory Inspection Management, PFIZER 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 JANSSEN CASE STUDY: BUILDING A QUALITY CULTURE Recognizing the Benefits of a Culture of Quality and Strategies for Implementation Krista 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. INTERACTIVE SESSION: ACHIEVING A CONFIDENT STATE OF INSPECTION READINESS Outlining Effective Strategies to Ensure Your Vendors and Sites Are Inspection Ready Facilitators: Cheryl McCarthy, RQAP-GCP, CQA, CBA, Associate Director, R&D Quality and Compliance, BIOGEN Michele Weitz, Director, GCP Compliance Operations, CLOVIS ONCOLOGY, INC. CONFERENCE CHAIR Ann Meeker-O Connell, Head, BioResearch Quality and Compliance, JOHNSON & JOHNSON Steve Whittaker, Senior Consultant, THE AVOCA GROUP; Executive Director, THE AVOCA QUALITY CONSORTIUM Kathy Goin, Vice President, Clinical Operations, TREVENA, INC. PRE-CONFERENCE DAY FULL-DAY INTERACTIVE SEMINAR The Changing GCP Regulatory Environment and the Impact on Clinical Compliance and Operations MORNING WORKSHOP An Inspection-Ready Trial Master File AFTERNOON WORKSHOP A Streamlined Vendor Prequalification Approach EXPERT S: What Happened to Simple Risk-Based Monitoring? Vendor Oversight Within Different Outsourcing Models Quality Management Systems Risk-Based Auditing Sponsors and Exhibitors Association Partners #CQOF Proactive GCP Compliance CQOF

2 7th Annual Clinical Quality Oversight Forum 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. Company 17% Other Clinical Service Providers 8% CROs 2015 Audience Profile 5% Other 70% Trial Sponsors 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 Function 8% Audits/Inspections 8% Outsourcing/Vendor Management Seniority 14% Other 30% Clinical Operations/ Management 24% Managers 7% Consultants/Other 40% Clinical Quality/Compliance Represented Director-Level 69% and Above 20% Presidents/CxOs/DMs 40% Directors 9% VPs/SVPs/EVPs

3 Monday, October 17, :45 Registration and Continental Breakfast 8:30 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 CONSULTANTS Celeste 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 FULL-DAY INTERACTIVE SEMINAR THE CHANGING GCP REGULATORY ENVIRONMENT 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 CONSULTANTS Celeste 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 Full-Day Seminar Continued THE CHANGING GCP REGULATORY ENVIRONMENT Pre-Conference Day HALF-DAY WORKSHOPS 7:45 Registration and Continental Breakfast 8:30 WORKSHOP A: TRIAL MASTER FILES Examining Common Trial Master File (TMF) Inspection Findings and Leveraging Metrics to Ensure an Inspection- Ready TMF Tipsuda 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 Participants 1:00 WORKSHOP B: VENDOR PREQUALIFICIATION 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, ENDOCYTE Dennis 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 3

4 Tuesday, October 18, :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 Today Moderator: 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 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 VISIONARY LEADERS 10:30 Networking and Refreshment Break 11:00 : VENDOR OVERSIGHT WITHIN DIFFERENT OUTSOURCING MODELS Examining the Challenges and Best Practices for Conducting Clinical Quality Oversight of Vendors Under Different Partnership Models 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. 4 CQOF Main Conference Day One 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 Programs John 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 Ready Facilitators: 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 INTERACTIVE SESSION 3:00 Networking and Refreshment Break 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

5 Tuesday, October 18, :30 : QUALITY MANAGEMENT SYSTEMS Leveraging a Quality Management System (QMS) to Oversee Clinical Partners and Mitigate Risk Tammy Clark, Director, Clinical Development Quality, PFIZER Karen Conway, Associate Director, Clinical Quality Assurance, MARATHON PHARMACEUTICALS Calvin H. Kim, Senior GxP IT Auditor, R&D Quality, BAYER Main Conference Day One 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 4:30 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 Wednesday, October 19, :00 Continental Breakfast 8:30 CHAIRPERSON S OPENING AND RECAP OF PREVIOUS DAY Kathy 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 CASE STUDY Main Conference Day Two 9:30 : RISK-BASED AUDITING Discussing the Pros and Cons of Varying Vendor Auditing Strategies that Effectively Assess Risk and Optimize Resources Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP, Principal Specialist, Clinical Quality Assurance, BOSTON SCIENTIFIC Cheri Wilczek, President, CLINAUDITS, LLC ADDITIONAL 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 riskbased auditing experiences 10:30 Networking and Refreshment Break CQOF 5

6 Wednesday, October 19, 2016 Main Conference Day Two 11:00 11:45 TRACK A TAKEDA CASE STUDY: Examining the Foundation Principals of Vendor Oversight that Produce Quality Sarah 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 UCB CASE STUDY: 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. 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 12:30 Lunch VENDOR OVERSIGHT IMPLEMENTATION COMMUNICATION GOVERNANCE TRACK B JANSSEN CASE STUDY: BUILDING A QUALITY CULTURE Recognizing the Benefits of a Culture of Quality and Strategies for Implementation Krista 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 LILLY CASE STUDY: PROACTIVE INSPECTION READINESS APPROACH Examining the Drivers, Development and Implementation of a Proactive Inspection Readiness Approach Nathalie 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 CASE STUDIES 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 : WHAT HAPPENED TO SIMPLE RISK-BASED MONITORING? Is Today s Complex and Growing RBM Model Really What the Initial Regulations Intended It to Be? 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 REMARKS Kathy Goin, Vice President, Clinical Operations, TREVENA, INC. 3:30 Close of Conference 6

7 Venue Hilton Philadelphia at Penn s Landing 201 South Columbus Blvd. Philadelphia, PA If 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 HILTONS (8667) and request the group rate for ExL s October Meetings. The group rate is available until September 27, 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 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. Media Partners: PM36O THE FULL SPECTRUM OF PRODUCT MANAGEMENT Association Partners: 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...$2,095 Conference 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...$2,295 Conference Only...$1,995 Onsite Pricing Conference and Full-Day Seminar...$2,695 Conference and Two Workshops...$2,695 Conference and One Workshop...$2,395 Conference Only...$2,095 TERMS AND CONDITIONS: By registering for an ExL Events, Inc. 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8 q YES! Register me for this conference! Name: Title: Company: Dept: Address: City: State: Zip: Phone: Fax: Please make checks payable to: PMA" Method of Payment: q Check q Credit Card Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP BOSTON SCIENTIFIC Card Type: q MasterCard q Visa q AMEX Card Number: Exp. Date: Name on Card: Signature: Please contact me: q I m interested in marketing opportunities at this event q I wish to receive updates on ExL Pharma s upcoming events CONFERENCE CODE: C523 Michael R. Hamrell, Ph.D., Sunil Kotecha RAC, FRAPS, RQAP- PFIZER GCP, CCRA, MORIAH Cheryl McCarthy, RQAP- GCP, CQA, CBA, BIOGEN Ann Meeker-O Connell JOHNSON & JOHNSON Steve Whittaker THE AVOCA GROUP; THE AVOCA QUALITY