CLINICAL QUALITY OVERSIGHT

Transcription

1 5th Annual October 15-17, 2014 Sonesta Hotel, Philadelphia, PA CLINICAL QUALITY OVERSIGHT FORUM ENSURING TRIAL INTEGRITY BY EFFECTIVELY ASSESSING, OPTIMIZING AND MANAGING THE QUALITY OF CLINICAL VENDORS AND SITES FEATURED PRESENTATIONS INDUSTRY UPDATE Overview of Outsourcing Trends, Evaluating the Drivers and Understanding the Impact on Clinical Oversight Strategies Mitchell Katz, PhD, Executive Director, Medical Research Operations, PURDUE PHARMA QUALITY BY DESIGN Utilizing Protocol Design to Facilitate Quality Oversight and Optimize Compliance Donna Edgerton, Senior Director, Global Clinical Development, Compliance and Training, ALLERGAN PFIZER CASE STUDY: ASSESSING SITE HEALTH Development and Early Implementation of a New Site Health Assessment Program that Identifies Risk Using Predictive Analytics Cheryl Small, Senior Director & Global Lead, Compliance, Analytics and Intelligence, PFIZER CASE STUDY: COMPREHENSIVE AUDIT STRATEGY PLAN Designing a Comprehensive Audit Consisting of Multiple In-Process Vendor Audits and Internal Process Audits to Effectively Determine Compliance and Performance Angela Berns, Director and Head of Vendor Management, Clinical Quality Assurance, UCB BIOSCIENCES, INC. 1 Conference Chair Sharon Reinhard Director, Clinical Operations & Compliance iceutica, INC. EXPERT PANEL DISCUSSIONS: GCP Quality Management Systems Risk-Based Monitoring Effective Clinical Auditing Inspection Readiness HALF-DAY INTERACTIVE WORKSHOPS: Quality Management Between Sponsors and CROS Risk-Based Auditing Sponsors and Exhibitors: Association Partners: C O M P L I A N C E IMPLEMENTATION SERVICES To Register Call or visit 1

2 Dear Colleague, An effective clinical oversight strategy is critical to the success of your trial. With clinical outsourcing at an all-time high and continuing to rise, risk-based monitoring and other riskdriven quality management approaches being implemented industry-wide, and new GCP quality management systems and processes being adopted, the complexities are many and the challenges great to effectively assessing, optimizing and managing the quality of your clinical partners. Now in it s celebrated 5th year, ExL s Clinical Quality Oversight Forum provides a unique interactive forum for clinical professionals to share, discuss and develop ideas and strategies for identifying and mitigating clinical risk when working with clinical vendors and sites. Join us and engage with like-minded professionals to take-away practical tools to improve your clinical quality oversight strategies. I look forward to greeting you in October and please don t hesitate to contact me with any questions. Sincerely, 5th Annual CLINICAL QUALITY OVERSIGHT Kristen Hunter Event Director khunter@exlpharma.com HOTEL INFORMATION Sonesta Hotel Philadelphia 1800 Market Street Philadelphia, PA Phone: (215) FORUM ENSURING TRIAL INTEGRITY BY EFFECTIVELY ASSESSING, OPTIMIZING AND MANAGING THE QUALITY OF CLINICAL VENDORS AND SITES The Sonesta Hotel Philadelphia offers a spectacular downtown location that is convenient to whatever brings you to the city. Located near Rittenhouse Square, in Center City, the hotel is within the business district and many popular Philadelphia attractions. With 445 well appointed guest rooms, 24-hour fitness center, roof top swimming pool, and 16,000 square feet of meeting space, the Sonesta Hotel Philadelphia is a wonderful location from which to explore all that. To make reservations guests can call and request the negotiated rate for Exl s October Meetings The group rate is available until September 23rd, Please book your room early as rooms available at this rate are limited. DO YOU WANT TO REACH THE AUDIENCE AT THIS EVENT? If this audience represents your potential clients, then 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 event. ExL works closely with you to customize a package that suits all of your needs. WHO SHOULD ATTEND? The event is designed for C-Level, Vice President, Director & Manager level executives at Pharma/Biotech/ Medical Device companies, CROs, and other Clinical Service Providers with 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 2013 AUDIENCE PROFILE Attendees by Company 15% 9% 11% 65% Attendees by Department 7% 14% 32% 47% 65% Pharma, Biotech, Device 11% CROs 15% Other Clinical Service Providers 9% Other 47% Clinical Quality/ Compliance 32% Clinical Operations/ Management 7% Outsourcing/ Supplier Management 14% Other 2

3 WEDNESDAY, OCTOBER 15, 2014 WORKSHOPS 8:00 Registration and Continental Breakfast for Conference Participants 8:30 WORKSHOP A: QUALITY MANAGEMENT BETWEEN SPONSORS AND CROs Approaches to Effective Oversight & Operationalizing Best Practices for Quality Management between Sponsors and CROs Janis L. Hall, MBA, COP, Senior Consultant, THE AVOCA GROUP Janice Hutt, Chief Operating Officer, THE AVOCA GROUP Aligning quality expectations between sponsors and CROs Defining what constitutes effective oversight Strategies for avoiding micromanagement and duplication of efforts Overview of the Quality Agreement core components and how to operationalize the agreement Walk through the Avoca Quality Consortium s Quality Agreement template In-depth discussion of the areas of the Agreement that generate the most discussion during negotiations regarding quality expectations Understanding how different companies are using these Agreements Sharing of relevant data from the Avoca Quality Consortium benchmarking research and the eight-component framework for effective oversight Lessons learned from the implementation of proactive approaches to quality management and applying best practices for effective oversight Engage in an interactive exercise where sponsors and CROs reverse their roles in a mock meeting Discuss operationalizing best practices regarding quality to ensure there is complete clarity from both the sponsor and CRO perspectives 10:30 30-Minute Networking Break 12:00 Workshop Concludes/ Lunch for Morning Workshop Participants 12:30 Registration for Afternoon Workshop 1:00 WORKSHOP B: RISK-BASED AUDITING Developing and Executing an Effective Risk-Based Auditing Plan to Proactively Identify Risk and Ensure Site and Vendor Compliance Elizabeth Ronk Nelson, President, REGULATORY RISK MANAGEMENT, LLC Auditing and monitoring: Separate (but complementary) responsibilities for ensuring compliance Defining risk-based auditing and its relationship to traditional auditing Effectively utilizing risk-based auditing as a quality risk management tool Assessing risk when selecting vendors and sites Risk management through ongoing examination of metrics and endpoints Setting risk acceptance thresholds Reporting on identified risk areas Elements of a risk-based auditing plan Comparison to the risk-based monitoring and vendor oversight plan Best practices for effectively executing the risk-based auditing plan Optimizing the timing Auditing of monitoring procedures and activities Adjusting the auditing plan based on collected data Evaluating the use of risk-based auditing in relation to recent noncompliance trends Interactive exercise analyzing a protocol to identify areas of risk and then developing an effective risk-based auditing plan 2:30 30-Minute Networking Break 4:30 Workshop Concludes THURSDAY, OCTOBER 16, :30 Registration and Continental Breakfast for Conference Participants 8:15 CHAIRPERSON S WELCOME AND OPENING REMARKS Sharon Reinhard, Director, Clinical Operations & Compliance, ICEUTICA, INC. Why is clinical oversight necessary? Elements to consider when determining the optimal level of oversight Defining differences and similarities when overseeing outsourced services such as monitoring, data management, statistics, ediary, labs, etc. 3 MAIN CONFERENCE 8:45 INDUSTRY UPDATE Overview of Outsourcing Trends, Evaluating the Drivers and Understanding the Impact on Clinical Oversight Strategies Mitchell Katz, PhD, Executive Director, Medical Research Operations, PURDUE PHARMA Examining outsourcing trends for small, mid and large sized companies and predictions for the future Breakdown of most common contracted services The impact of off-shoring on oversight strategies How are partnerships changing and what is the impact on oversight? Understanding what s driving these changes Regulatory and industry initiatives Effective risk-mitigation The impact of risk-based approaches to quality management on oversight strategies 3

4 9:30 SELECTION AND QUALIFICATION Identifying Strategic Clinical Vendors and Minimizing Risks through Effective Qualification Dirk Roels, Director, Quality Assurance Analysis, Pharmaceutical R&D Q&C, JANSSEN, PHARMACEUTICAL COMPANIES OF JOHNSON & JOHNSON Effective strategies for identifying appropriate candidates from the financial, business and quality perspectives Best practices for assessing capabilities and risks What questions to ask to determine capabilities, establish the risk level, quality systems and appropriateness of a potential partner Interpreting the response data and establishing a risk level When is a qualification assessment required and should some partners be considered pre-qualified? Lessons learned from common vendor audit findings on how to improve the selection and qualification process 10:15 Networking and Refreshment Break 10:45 QUALITY BY DESIGN Utilizing Protocol Design to Facilitate Quality Oversight and Optimize Compliance Donna Edgerton, Senior Director, Global Clinical Development, Compliance and Training, ALLERGAN Recognizing the protocol as the primary tool to facilitate and support quality conduct of the trial Examining elements of a the protocol design that can improve or detract from compliance Assessing the protocol feasibility Determining the clarity and complexity Optimizing site education and compliance through a well-designed protocol Strategies for reducing the number of amendments Effectively communicating the importance of protocol design internally to influence change, improve the process and optimize clinical quality 11:30 PANEL DISCUSSION: GCP QUALITY MANAGEMENT SYSTEMS Optimizing Oversight through the use of Quality Management Systems to Identify and Mitigate Risks Moderator: Katie D. Alberta, BSN, Global Head, CQA; GCP & GPvP, ALKERMES, INC. Panelists: Frances DeGennaro-Culver, Director, Clinical Research, Clinical Quality & Process Management, MERCK Margo Holland, Director, Quality Assurance GCP, VERTEX PHARMACEUTICALS INC. Dirk Roels, Director, Quality Assurance Analysis, Pharmaceutical R&D Q&C, JANSSEN, PHARMACEUTICAL COMPANIES OF JOHNSON & JOHNSON Kevin J. Wilson, Manager-Medical Quality, Global Medical Quality Systems, ELI LILLY & CO. What is a quality management system (QMS)? Defining the purpose, value, core and critical elements Examples of effectively utilizing a quality management system to monitor organizational performance and trial execution of vendors and sites Assessing vendor quality management systems early in the vendor 12:30 Lunch selection and qualification process and on an ongoing basis Identifying potential risk factors based on QMS assessment Challenges, pitfalls and lessons learned when implementing and utilizing a QMS 1:30 VENDOR OVERSIGHT CAPABILITY Instituting a Vendor Oversight Capability to Ensure Vendor Oversight is Properly Executed Kirsten Morasco, Vice President, Clinical Quality & Compliance, COMPLIANCE IMPLEMENTATION SERVICES (CIS) Defining vendor oversight capability within a holistic view of vendor oversight Understanding the critical elements and benefits of a sustainable vendor oversight capability Identifying the components of a vendor oversight capability maturity model Assessing and implementing a vendor oversight capability within your own organization Case study examples of improved oversight resulting from the institution of a vendor oversight capability 2:15 PFIZER CASE STUDY: ASSESSING SITE HEALTH Development and Early Implementation of a New Site Health Assessment Program that Identifies Risk Using Predictive Analytics Cheryl Small, Senior Director & Global Lead, Compliance, Analytics and Intelligence, PFIZER Successfully moving from a retrospective find and fix method to a proactive, predictive approach Harnessing big data from hundreds of studies and thousands of sites to develop 4-5 algorithms that predict poor outcomes Evaluating what types of data are being used and why it was determined that these key drivers predict poor outcomes Using the resulting data to influence site selection, resource deployment, oversight and management processes Challenges, key takeaways, best practices and lessons learned from early implementation 3:00 Networking and Refreshment Break 3:30 CASE STUDY: THIRD-PARTY QUALITY OVERSIGHT Realizing the Operational Benefits to Utilizing a Third- Party Quality Oversight Program John R. Wilson, Jr., PhD, Senior Vice President, BEAUFORT LLC Utilizing a third-party to eliminate bias and achieving independence to accurately assess performance A third-party quality oversight program as a complement to other oversight activities, not effort duplication Allowing operational teams to focus on CAPA and quality enhancing measures rather than administration of the process Early process and operational improvements as a result of a thirdparty quality program Third-party quality oversight to facilitate an efficient inspection readiness process 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. - Maryann Livolsi, SHIRE PHARMACEUTICALS 4

5 4:15 PANEL DISCUSSION: RISK-BASED MONITORING Identifying and Managing Risk by Leveraging Clinical Data to Target Monitoring Efforts Moderator: Kathy Goin, Vice President, Clinical Operations, TREVENA, INC. Panelists: Mitchell Katz, PhD, Executive Director, Medical Research Operations, PURDUE PHARMA Rivka Kerachsky, Director, Clinical Data Management, THEOREM CLINICAL RESEARCH Linda Sullivan, Chief Operating Officer, METRICS CHAMPION CONSORTIUM Howard Waxman, PhD, Director of Psychiatric Research, CRI LIFETREE Defining risk-based monitoring and evaluating the pros and the cons What are the risks associated with this approach? Should increased resources and time be allocated? Best practices for mapping out the process and developing a riskbased monitoring plan How was the workforce re-evaluated and applied? Determining changing training needs Examining clinical data and trends and adjusting monitoring efforts based upon identified risks What does success look like? What are we standing to gain through RBM? 5:15 ROUNDTABLE DISCUSSIONS Choose your preferred topic to discuss in an intimate setting. 1. EFFECTIVE TRAINING: Identifying the Changing Training Needs as Clinical Oversight Demands Evolve 2. eclinical VENDOR OVERSIGHT: Strategies for Effectively Overseeing an eclinical Vendor to Ensure Quality and Performance 3. TRIAL MASTER FILE: Effectively Utilizing a TMF or etmf to Oversee and Manage Clinical Quality of Vendors and Sites 4. DOCUMENTING OVERSIGHT: Utilizing Simple Tools to Effectively Document Oversight 5. ESCALATION PLANS: Discussing the Critical Elements of an Effective Issue Escalation Plan and Overcoming Execution Obstacles 6. CHANGING ROLES OF MONITORS & AUDITORS: Examining the Evolving Roles of Monitoring and Auditing with the Development of Risk-Based Oversight 7. RISK-BASED AUDITING: Defining Risk-Based Auditing, it s Impact on Oversight, and Best Practices for Execution 8. INTERNATIONAL OVERSIGHT: Best Practices for Overseeing Quality when Working with Vendors and Sites on a Global Level 9. VENDOR CONTRACTS: How to Develop a Contract that Effectively Incorporates Quality Requirement and Oversight Expectations 10. SMALL TO MID-SIZED COMPANY CHALLENGES: Discussing Resource Issues and Operational Concerns Unique to Smaller Companies 6:00 Day Concludes FRIDAY, OCTOBER 17, 2014 MAIN CONFERENCE 7:45 Registration and Continental Breakfast for Conference Participants 8:15 Chairperson s Introduction to Day Sharon Reinhard, Director, Clinical Operations & Compliance, ICEUTICA, INC. 8:30 CASE STUDY: COMPREHENSIVE AUDIT STRATEGY PLAN Designing a Comprehensive Audit Consisting of Multiple In-Process Vendor Audits and Internal Process Audits to Effectively Determine Compliance and Performance Angela Berns, Director and Head of Vendor Management, Clinical Quality Assurance, UCB BIOSCIENCES, INC. The components of the comprehensive audit and developing a Master Audit Plan Assembling an effective assessment team to conduct and manage the audits Identifying and measuring the outputs and deliverables of the partnership Interpreting the audit yields and benefits 9:15 PANEL DISCUSSION: EFFECTIVE CLINICAL AUDITING Developing and Executing an Audit Strategy as an Effective Oversight Tool and Using the Findings to Generate Action Plans to Mitigate Risk Panelists: Angela Berns, Director and Head of Vendor Management, Clinical Quality Assurance, UCB BIOSCIENCES, INC. Nicky Dodsworth, Vice President, Global Quality Assurance, PREMIER RESEARCH Cheri Wilczek, President, CLINAUDITS, LLC Identifying critical components of an effective audit plan Discussing the benefits of a risk-based auditing approach Strategies 5 for assembling an effective assessment team to conduct and manage auditing The importance of root cause analysis and effectiveness checks in helping ensure repeat audit findings are reduced. Elevation of compliance issues to QA how are these issues incorporated into audit schedules? Coordinating audit activity and avoiding redundancies between sponsor and CRO audits Identifying and measuring audit outputs and deliverables Interpreting the audit results and generating effective action items to ensure compliance 10:15 Networking & Refreshment Break 5

6 10:45 CASE STUDY: QUALITY AGREEMENTS Developing an Effective Quality Agreement with your Clinical Partner to Optimize Performance and Minimize Risk Margo Holland, Director, Quality Assurance GCP, VERTEX PHARMACEUTICALS INC. Defining the purpose of the quality agreement Comparing the quality agreement and contract Defining the critical elements to an effective quality agreement Walking through a sample agreement 11:30 COMMUNICATION OPTIMIZATION & MANAGEMENT Streamlining, Managing and Documenting Communication between Sponsor, CRO and Investigator Site to Optimize Trial Integrity Jennifer J. Poulakos, PhD, Director, Development Quality Assurance, AGENSYS INC., an affiliate of ASTELLAS PHARMA, INC. 12:15 Lunch TRACK A Developing a communication plan/strategy to ensure effective internal and external communication Clearly defining internal and external roles and responsibilities for executing and communicating oversight activities The use of risk management tools and metrics to identify when and what type of communication is necessary Ensuring all necessary parties are aware of milestones, deliverables and when escalation is necessary TRACK B SMALL TO MID-SIZED COMPANY CHALLENGES Overcoming Oversight Challenges in Small to Mid-Size Companies by Leveraging Resources, Data and Tools Sharon Reinhard, Director, Clinical Operations & Compliance, ICEUTICA, INC. What resources can be utilized to execute oversight activities? Making metrics and data work for you to identify trends to focus oversight activities Utilizing simple tools to execute oversight activities Strategies for documenting oversight to help navigate a Sponsor Inspection VIRTUAL COMPANY CASE STUDY Design, Implementation and Management of an International Risk-Based Oversight Program Focused on Quality Performance at CRA and Site Levels Kimberly Feir Brooks, RN, BSN, RQAP-GCP, Former Quality Oversight Program Lead, DURATA THERAPEUTICS Why the decision was made to implement a risk-based oversight program Outlining the goals of the program and the intended accomplishments Developing a Quality by Design cycle of consideration Plan-Do-Check- Act Identifying key performance indicators to assess quality performance standards Methods used to evaluate quality at the CRA and site levels Reviewing the keep it simple and scientific principles when completing a risk assessment Implementation results, challenges and lessons learned 1:15 AMGEN CASE STUDY: FUNCTIONAL SERVICE PROVIDER MODEL Implementing a Global Functional Service Provider (FSP) Model Focusing on Specific Roles to Effectively Oversee Clinical Quality Karen Koroly RN, BSN, Clinical Site Management, Oversight Manager, AMGEN Defining the FSP model and how it contributes to Amgen s clinical trial execution platform How the FSP model is used to measure and maintain clinical quality The core oversight and support roles and their responsibilities Overview of the global supplier governance structure Defining key performance indicators to manage supplier performance Key developments over the past year 2:00 PANEL DISCUSSION: INSPECTION READINESS A Retrospective Examination of How Oversight Techniques Could Have Been Improved to Optimize the Inspection Experience Moderator: Donna Edgerton, Senior Director, Global Clinical Development, Compliance and Training, ALLERGAN Panelists: Dwayne Brazelton, Director, Clinical Quality Assurance, MACROGENICS, INC. Suzanne Elliott, Director, PV Quality Management Compliance, VERTEX PHARMACEUTICALS INC. Jennifer J. Poulakos, PhD, Director, Development Quality Assurance, AGENSYS INC., an affiliate of ASTELLAS PHARMA, INC. Overview of each panelist s experiences with inspections and their outcome What oversight techniques worked and didn t work to ensure inspection readiness at the site level? What specific lessons did you learn from your inspection experiences? Is there anything you would you have done differently to prepare? 3:00 Close of Conference 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 or khunter@exlpharma.com and she d be happy to discuss with you any of the above or any other questions that you might have on this program. 6

7 REGISTRATION INFORMATION Registration Fees for Attending ExL s 5th Clinical Quality Oversight Forum: Early Bird Pricing Register by Friday, August 29th Conference and Both Workshops - $2,395 Conference and One Workshop - $2,095 Conference Only - $1,795 Standard Pricing - Register After August 29th Conference and Both Workshops - $2,595 Conference and One Workshop - $2,295 Conference Only - $1,995 Onsite Pricing Conference and Both Workshops - $2,695 Conference and One Workshop - $2,395 Conference Only - $2,095 Group Discount Program: 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 4 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. To find out more on how you can take advantage of these group discounts, please call contact our offices at (201) Important: Discount offers may not be combined. Discounts only apply to standard rate, early bird rate DOES NOT apply. Make checks Please payable make checks to ExL payable Events, to: PMA" Inc. and write code C481 on your check. You may also use Visa, MasterCard, Discover or American Express. Payments must be received in full prior to the commencement of the conference. Terms & Conditions: By registering for an ExL Events, Inc. ( ExL Pharma ) 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: Must be received in full by the conference date. All discounts will be applied to the Conference Only fee (excluding add-ons) cannot be combined with any other offer and must be paid in full at the time of order. Group discounts available to individuals must be registered simultaneously and employed by the same organization. Cancellation and Refund Policy If you need to cancel your registration for an upcoming ExL event, please note the following policies derived from the Start Date of the event: Four weeks or more:a full refund (minus a $295 processing fee) or a voucher to another ExL event valid for 18 months from the voucher issue date. Less than four weeks: A voucher to another ExL event valid for 18 months from the voucher issue date If you cancel at any time after receiving the conference documentation, the voucher issued will be $395 less 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 Pharma reserves the right to cancel any conference it deems necessary and will not be responsible for airfare hotel or any other costs incurred by registrants. ExL Pharma s liability is limited to the conference registration fee in the event of a cancellation and does not include changes in program date content speakers or venue. * The opinions of ExL 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 Events, Inc. s ( ExL s ) designated speakers and is designed for informational purposes for its attendees, and is NOT INTENDED for purposes of copywriting, nor 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 THE 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. 7ExL presentations may point to other Internet sites that may be of interest to you, however ExL does not endorse or take responsibility for the content on such other sites MEDIA PARTNERS CanBiotech R&D Outsourcing Capital Sourcing Competitive Intelligence PM36O THE FULL SPECTRUM OF PRODUCT MANAGEMENT 7

8 For registration options include: Yes! Register me for the Conference and Both Workshops Yes! Register me for the Conference and Workshop A (Quality Mgmt btw Sponsor and CROs) Yes! Register me for the Conference and Workshop B (Risk- Based Auditing) Yes! Register me for the Conference Only q YES! Register me for this conference! Name: Title: Company: Dept: Address: City: State: Zip: Phone: Fax: Method of Payment: q Check q Credit Card 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