Proactive GCP Compliance

6 TH ANNUAL Proactive GCP Compliance Effective Risk-Based Approaches for Optimizing Clinical Quality MARCH 24-25, 2015 Wyndham Philadelphia Historic District, Philadelphia, PA FEATURED SESSIONS REPONDING TO FINDINGS Effectively Responding to Critical Findings from Audits and/or Inspections to Mitigate Risk Doreen McGirl, Associate Director, Clinical Quality Management, OTSUKA PHARMACEUTICAL DEVELOPMENT & COMMERCIALIZATION, INC. RISK-BASED AUDITING Developing and Executing a Risk-Based Audit Approach to Optimize Resources and Proactively Identify Areas of Noncompliance Krista Kerr, Associate Director, Global R&D Quality & Compliance, JANSSEN MANAGING CLINICAL CAPAs Identifying and Utilizing Performance Metrics to Effectively Manage your CAPA Process QUALITY DOCUMENTATION Keeping and Maintaining Effective Documentation to Ensure and Demonstrate GCP Compliance : LEARNING FROM RECENT INSPECTIONS Experts Share Their Recent Inspection Experiences and What Lessons They Have Learned Moderator: David W. Fryrear, Senior Director, Clinical and Pharmacovigilance QA, ABBVIE Katie D. Alberta, BSN, Global Head, CQA; GCP & GPvP, ALKERMES, INC. Suzanne Elliott, Director, PV Quality Management Compliance, VERTEX PHARMACEUTICALS INC. CONFERENCE CHAIR Joanne Spallone Global Head Clinical Development Quality Assurance TOPICS Quality by Design Risk-Based Monitoring Learning from Recent Inspections Risk Management in Global Studies INTERACTIVE WORKSHOPS Clinical Risk Management at Small and Mid-Sized Companies GCP Education and Training SPONSORS & EXHIBITORS: ASSOCIATION PARTNER:

Dear Colleague, Now in its sixth year, Exl s Proactive GCP Compliance conference continues to act as the annual forum for senior-level clinical quality and clinical operations executives to gather, learn and discuss strategies to achieve and maintain global GCP compliance. Join us to learn how to effectively build quality risk management approaches into your clinical operations to optimize research, maintain GCP compliance, contain costs and ensure patient safety. I look forward to seeing you in March and please don t hesitate to contact me with any questions. Sincerely, Kristen Hunter Kristen Hunter Event Director, ExL Pharma khunter@exlevents.com Who Attended Last Year? 2014 EVENT AUDIENCE BREAKDOWN ATTENDEE BY COMPANY TYPE ATTENDEES BY FUNCTION 50% - Quality/Compliance 35% - Operations/Management 5% - Audits/Inspections 10% - Other 60% - Pharma, Biotech Device 12% - CROs 20% - Other Clinical Service Providers 6% - Sites 2% - Other Wyndham Philadelphia Historic District 400 Arch Street Philadelphia, PA 19106 www.phillydowntownhotel.com The Wyndham Philadelphia Historic District hotel is situated in the desirable and celebrated neighborhood of Old City Philadelphia. Philadelphia International Airport is a mere 12 miles away, and Philadelphia s Central Business District is just a quick cab ride through scenic streets. Located one block from Market Street and a five-minute walk to many of the city s iconic American Revolution landmarks including Independence Hall and the Liberty Bell this spacious hotel in Philly is a top choice for business and leisure travel. Take advantage of the adjacent parking garage, seasonal rooftop pool, fitness room and onsite dining, all provided with Wyndham s signature upscale quality of service. To make reservations please call 1-877-999-3223 and request the negotiated rate for ExL s March Meetings. You may also make reservations online using the following weblink: http://bit.ly/1wostwe. The group rate is available until March 2, 2015. Please book your room early as rooms available at this rate are limited. The 5th Annual GCP Compliance conference delivered on all fronts. The speakers and attendees were knowledgeable and many were influencers or directors of strategy in their respective organizations. The mixed format (talks, workshops, panels, roundtables) kept us all engaged and afforded excellent opportunities for the exchange of ideas as well as networking. I hope to be back next year! Nicholas Hargaden, President, Algorithm, Inc. Who Should Attend? Professionals from pharma, biotech and medical device companies; CROs; and other clinical trial service providers whose responsibilities involve the following should attend this conference: Good Clinical Practice (GCP) Clinical Quality Assurance (CQA) Clinical Quality Control (CQC) Compliance/Global Compliance Quality Management/ Global Quality Management 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. To learn more about these valuable opportunities, please contact: Andrew Sinetar 212-400-6237 asinetar@exlevents.com Clinical Operations/ Management Clinical Monitoring Audits/Inspections Clinical Data Regulatory Affairs Safety and Risk Management/ Operations This conference is also relevant to clinical QA, compliance and operations professionals from: Quality Service Providers and Consulting Companies Central, Imaging and ECG Labs Investigative Sites IRBs Data Management and Software Vendors Safety Reporting Vendors

Day One Tuesday, March 24 th 7:45 Registration Opens and Continental Breakfast for Workshop Participants 8:30 CHOOSE BETWEEN THE FOLLOWING WORKSHOPS WORKSHOP A CLINICAL RISK MANAGEMENT AT SMALL AND MID-SIZED COMPANIES Effectively Designing and Executing Clinical Quality Risk Management Approaches with Limited Resources Tracey Douglass, MBA, Senior Manager, Development Quality, ALEXION R&D QA Kathy Goldstein, PharmD, CCRA, Director, Development Quality, ALEXION R&D QA Why a Risk-Based Approach? Analyzing what a risk-based approach means at a smaller company and the potential benefits Examining possible risk-based strategies for clinical quality management that make sense at a smaller company Developing the Strategy/Plan Effectively prioritizing clinical quality goals and creating applicable steps to achieve them Performing a risk analysis of the program to determine where errors and challenges may occur Reviewing available data, resources and infrastructure to determine what can be accomplished Gaining internal buy-in along with external cooperation from CRO partners Writing an effective risk-based management plan and identifying the critical components Executing the Strategy Identifying key metrics to trend data and measure performance Developing an effective oversight plan to ensure effective and compliant execution Strategically monitoring site performance with available tools and resources WORKSHOP B GCP EDUCATION AND TRAINING Moving Beyond Basic GCP Training to Education Methods that Support Performance and Quality Liz Wool, CCRA, CMT, President & CEO, QD-QUALITY AND TRAINING SOLUTIONS, INC. Examining GCP Training Examining what the regulators including the FDA, EMA and MHRA are communicating and evaluating Discussing why basic GCP training is no longer working Understanding what types of training meet the expectations of the regulatory authorities Developing a Training Approach Assessing your current training state and conducting a gap analysis to develop your training strategy Determining if employees are deemed qualified for their roles and responsibilities Designing effective education and training strategies to target rolebased training requirements to meet regulatory expectations Changing Training Needs Examining the root cause of poor site performance to determine what training elements are needed 10:00 30-Minute Networking and Refreshment Break 12:00 Lunch for Workshop Participants/Registration Opens for Main Conference 1:00 CHAIRPERSON S OPENING REMARKS AND INDUSTRY UPDATE Joanne Spallone, Global Head, Clinical Development Quality Assurance, Examining the changing culture of clinical research Evaluating the movement to optimize quality through risk-based approaches 1:30 CASE STUDY: PROACTIVE COMPLIANCE MODELS Employing Proactive Approaches for Determining Potential Problem Areas to Prevent Noncompliance and CAPA CASE STUDY Yvonne Barnes, Senior Director, Corporate Strategy Development, QUINTILES Cost benefits of building in quality through prevention Collecting the appropriate data to identify trends, determine root causes and enact process improvements Developing proactive strategies based upon risks to prevent noncompliance Effective vendor oversight and documentation to identify potential issues 2:15 QUALITY BY DESIGN Effective Strategies for Employing Quality by Design Principles to Minimize Risk Nicky Dodsworth, Vice President, Global Quality Assurance, PREMIER RESEARCH Kelly Fenner, Associate Director, Portfolio Quality & Risk Management, PFIZER Carlos Seminario, MD, Regional Director, GMD Clinical Operations, Site Management and Monitoring Americas, ASTRAZENECA PHARMACEUTICALS LP Defining the purpose, principles and concepts of quality by design (QbD), and its application in clinical research Developing strategies for implementing QbD in the clinical trial setting Common implementation hurdles and how they were overcome Reviewing specific case study examples of how QbD has been implemented and the subsequent results/impact 3:15 Networking and Refreshment Break 3:45 GxP COMPLIANCE STRATEGIES Harmonizing GCP, GLP and GMP Compliance Strategies for Continuous Process Improvement Joe Goodman, Director, Solutions Consulting, SPARTA SYSTEMS Identifying the commonalities across GCP, GLP and GMP guidelines Examining how requirements transfer across each discipline Evaluating the benefits to having one harmonized approach to compliance Reviewing examples of how leading companies have created transparency across GxP Mitigating risk in an outsourced environment through one consistent compliance approach 4:30 QUALITY DOCUMENTATION Keeping and Maintaining Effective Documentation to Ensure and Demonstrate GCP Compliance Identifying the critical documents needed to track and ensure compliance Determining who should be responsible for writing, owning and tracking documentation changes Deciding who should have access to which documents? (E.g. sites, vendors) Effective strategies for tracking and recording documentation changes This was probably the best industry conference I have attended. It was well worth attending and featured many talented speakers who shared their valuable expertise. I learned a great deal. Lisa Murphy, Associate Director, R&D Compliance, Biogen Idec

5:30 ROUNDTABLE DISCUSSIONS Each Conference Participant Selects One Topic to Discuss in an Intimate Setting 1. RISK INDICATORS: Defining Risk Indicators that Proactively Identify Potential Areas of Noncompliance ROUNDTABLES 2. AUDITING RISK-BASED MONITORED TRIALS: Best Practices and Challenges Where Auditing Trials where Risk- Based Monitoring/Management is Utilized 3. GCP QUALITY AGREEMENTS: Defining the Purpose of a Quality Agreement and the Critical Components 4. CLINICAL CAPAs: Best Practices for Defining, Developing and Executing Clinical Corrective and Preventive Actions 6:15 Close of Day One 7:30 Registration and Continental Breakfast for Conference Participants 8:15 CHAIRPERSON S OPEN TO DAY TWO Joanne Spallone, Global Head, Clinical Development Quality Assurance, 8:30 RISK-BASED AUDITING Developing and Executing a Risk-Based Audit Approach to Optimize Resources and Proactively Identify Areas of Noncompliance Day One Tuesday, March 24 th Day Two Wednesday, March 25th Krista Kerr, Associate Director, Global R&D Quality & Compliance, JANSSEN Defining risk-based auditing and its relationship to traditional auditing Effectively utilizing risk-based auditing as a quality risk management tool Defining elements of a risk-based auditing plan Discussing best practices for effectively executing the riskbased auditing plan Evaluating the use of risk-based auditing in relation to recent noncompliance trends 9:15 RISK-BASED MONITORING Identifying the Challenges, Overcoming Obstacles and Sharing Best Practices for Effective Execution of Risk-Based Monitoring Yvonne Barnes, Senior Director, Corporate Strategy Development, QUINTILES Krista Kerr, Associate Director, Global R&D Quality & Compliance, JANSSEN Describe actions that have been taken at your company/ institution to enable effective risk-based monitoring What are the challenges and obstacles associated with riskbased monitoring and how are they being overcome? How are sites handling this approach to monitoring? What accommodations have been made at the site level? What results have you seen from risk-based monitoring? How are regulatory agencies viewing risk-based monitoring? What are the best strategies for measuring the effectiveness of risk-based monitoring? 10:15 Networking and Refreshment Break I found the conference offered a great balance of presentations, workshops, panel and roundtable discussions, attended by and facilitated by such a talented group of experts for me that was a winning combination! Anne Varker, Associate Director, Clinical Quality Assurance, BOEHRINGER INGELHEIM PHARMACEUTICALS, INC. 5. ESCALATION PLANS: Developing and Executing an Effective Escalation Plan to Mitigate Risks and Address Issues Appropriately 6. INTERNAL OPERATIONS: Ensuring Compliance and Clinical Teams Function and Communicate Effectively 7. FDA vs. EMA INSPECTIONS: Identifying the Different Areas of Focus and Interest when Being Inspected by the FDA vs. EMA 8. SMALL TO MID-SIZED COMPANY COMPLIANCE CHALLENGES: Maintaining GCP Quality Standards in Clinical Research with Limited Resources 9. RISK-BASED MANAGEMENT PLAN: Identifying the Critical Components of a Successful Risk-Based Management Plan 10:45 : LEARNING FROM RECENT INSPECTIONS Experts Share Their Recent Inspection Experiences and What Lessons They Have Learned Moderator: David W. Fryrear, Senior Director, Clinical and Pharmacovigilance QA, ABBVIE Katie D. Alberta, BSN, Global Head, CQA; GCP & GPvP, ALKERMES, INC. Suzanne Elliott, Director, PV Quality Management Compliance, VERTEX PHARMACEUTICALS INC. Overview of panel s recent inspection experiences When was your inspection? What agencies do you have recent experience with? Do you feel there has been an increase in the number of inspections and observations? What do regulatory agencies want to see or are requiring related to the quality management system (QMS)? How are they evaluating the QMS? Identifying the differences between varying regulatory agency inspections and how that impacts preparation What lessons learned or advice would you give as a direct result of your inspection experience? 11:45 RESPONDING TO FINDINGS Effectively Responding to Critical Findings from Audits and/or Inspections to Generate an Action Plan that Mitigates Risk Doreen McGirl, Associate Director, Clinical Quality Management, OTSUKA PHARMACEUTICAL DEVELOPMENT & COMMERCIALIZATION, INC. Developing effective tools and methodologies for categorizing and prioritizing findings Determining risk, criticality and if a CAPA is necessary Defining actions based on the criticality of the findings and deciding whether escalation and root cause investigation are necessary Utilizing risk-based decision-making to implement actions Assigning appropriate levels of visibility regarding the findings at sponsor, site and CRO 12:30 Lunch 1:30 MANAGING CLINICAL CAPAS Identifying and Utilizing Performance Metrics to Effectively Manage your CAPA Process Defining the CAPA management process in clinical research Assessing which metrics are critical to measure and improve the CAPA process Integrating these metrics into your CAPA process to optimize management and streamline actions Utilizing the right metrics to drive improvement and prevent future CAPAs ROUNDTABLES

2:15 RISK MANAGEMENT IN GLOBAL STUDIES Effective Risk-Based Approaches for Maintaining GCP Compliance when Working Internationally Jessica Lee, Vice President, Clinical Operations & Compliance, INOVIO PHARMACEUICALS Jodi Meck, Director, Clinical Quality and Process Management, MERCK Michael Sobczyk, Senior Director, Regulatory Compliance, GILEAD SCIENCES Evaluating the varying international definitions of GCP compliance Comparing international standards vs. country-specific regulations, guidances and practices Instituting strategies for staying current on important regulatory changes or updates that impact the compliance of global clinical studies Implementing risk-based strategies for selecting and overseeing vendors abroad Overcoming compliance challenges in emerging regions Identifying quality challenges unique to the ASIAPAC region 3:15 Conference Concludes I found the focus on risk management to be so relevant. It was great to hear how other companies are managing the process; how they approached it, lessons learned and change management. I also realized many of us are facing the same issues and I walked away with new relationships knowing I could pick up the phone and find out how other s risk management journey was progressing while still able to maintain company confidentialities. Will definitely try to attend next year. Eva DeMartin, Director, Global Compliance and Training, Allergan REGISTRATION INFORMATION 5 WAYS TO REGISTER ExL Events, Inc. 494 8th Avenue, 4th Floor New York, NY 10001 www.exlpharma.com/gcp REGISTRATION FEES 866-207-6528 888-221-6750 registration@exlevents.com EARLY BIRD PRICING REGISTER BY FRIDAY, FEBRUARY 6TH Conference and Workshop $2,095 Conference Only $1,795 MEDIA PARTNERS STANDARD PRICING REGISTER AFTER FEBRUARY 6TH Conference and Workshop $2,295 Conference Only $1,995 ONSITE PRICING Conference and 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 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. To find out more on how you can take advantage of these group discounts, please call 866-207-6528. Important: Discount offers may not be combined. Discounts only apply to standard rate; early bird rate DOES NOT apply. Make checks payable to ExL Events, Inc. and write code C521 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 12 months from the voucher issue date. Less than four weeks: A voucher to another ExL event valid for 12 months from the voucher issue date. If you cancel at any time after receiving the conference documentation, the voucher issued will be $395 less. 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 Kristen Hunter, Event Director, at 212-400-6241 or khunter@exlevents.com. She is happy to discuss the above topics with you, as well as any other questions you may have about this program. 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 costs 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 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. 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