TRIAL MASTER FILE 4TH. January 21-23, 2015 / KEY BRIDGE MARRIOTT / ARLINGTON, VA

Transcription

1 4TH TRIAL MASTER FILE SUMMIT Best Practices to Enhance TMF Collection, Monitoring, Utilization, Quality and Archiving While Remaining Compliant for Audits and Inspections January 21-23, 2015 / KEY BRIDGE MARRIOTT / ARLINGTON, VA CONFERENCE CHAIRED BY: JOIN THE TRIAL MASTER FILE FAMILY! BUILD LASTING RELATIONSHIPS AT THE ONLY CONFERENCE DEDICATED TO PAPER AND ELECTRONIC TMF FEATURING A SPEAKING FACULTY OF 25+ INCLUDING: SUKH CHUGH DIRECTOR, R&D, IS ALLERGAN VINITA LESLIE Director, Trial Master File Process Owner, Regulatory Operations, BIOGEN IDEC KAREN ROY Global Business Development Director IVAN WALRATH Trial Master File Process Owner PFIZER BETSY FALLEN DIRECTOR, SITE READY AND CLINICAL DEVELOPMENT OPERATIONS FORMER MERCK KEY LEARNING OBJECTIVES FOR 2015: Review new and updated regulations from the MHRA, FDA, EMA and PMDA Learn what an investigator is looking for to ensure your TMF is in a continuous state of inspection readiness Streamline your paper TMF to optimize security and global accessibility Training techniques to ensure your staff will keep the site running in an effective and compliant manner ALEX MARKIEL SENIOR MANAGER, CLINICAL SYSTEMS BIOMARIN ERIC RUBINSON DIRECTOR REGULATORY AFFAIRS OPERATIONS FOREST LABORATORIES Overcome hurdles to etmf implementation to reap the benefits of active workflows to support study conduct and metadata knowledge management FEATURING AN ALL-NEW, INTERACTIVE TRAINING DAY FOR 2015 COVERING: Demystifying etmf Business Process Modeling Leverage Knowledge Management to Improve Clinical Trials The Criticality of Change Management in etmf Implementation Projects SPONSORED BY JANE TWITCHEN ASSOCIATE DIRECTOR OF RECORDS MANAGEMENT BIOGEN IDEC NEW TO TMF? Start your career off on the right foot by attending our exclusive Dinner Workshop: TMF 101: An Introduction to Managing the Most Crucial Content Created in Support of a Clinical Trial and explore the essential documents that make up a TMF while networking with key players in the industry. W ingspan Technology, Inc.

2 DEAR COLLEAGUE, Regulators worldwide require Sponsor companies to assemble a comprehensive Trial Master File during clinical trials. This means filing and maintaining hundreds of thousands of sensitive clinical documentation. Although the clinical trial itself might be conducted by a CRO, at the end of the day it is the sponsor company that is held accountable. Sponsor companies must have to navigate multiple global regulations, train employees on TMF management best practices, participate in filing documents and must be ready for inspection at any time, at any site across the globe. ExL Pharma s 4th Trial Master File Summit explores optimizing a TMF process to improve TMF completeness, document quality and efficiency. Our thought leaders will guide you through recent updates to guidelines released by the Medicines and Healthcare Products Regulatory Agency (MHRA), European Medicines Agency (EMA), the U.S Food and Drug Administration (FDA) and Pharmaceuticals and Medical Devices (PMDA) to complete your understanding of these regulations as well as address the history and reasoning behind them to give you a much needed leg-up when an inspector shows up at your clinical trial site. There has been a subtle, almost imperceptible shift to the way TMF management is being approached. Rather than simply being paperwork, it can be leveraged as a tool to elevate the quality of your clinical trial through proactive knowledge management. The 4th Trial Master File Summit, January 21-23, 2015 in Arlington, VA will examine all aspects of the TMF process, starting with the basics and moving up to the latest in technology and data management. YOU ASKED FOR CONTENT SPECIFICALLY ADDRESSING THE TOPICS BELOW AND WE ARE DELIGHTED TO PROVIDE YOU WITH 8 UNIQUE CASE STUDIES ON: Create Cross-Functional Teams for etmf Implementation Harmonize TMF Practices Across all Clinical Trial Sites to Ensure TMF Consistency Ensure a High performing TMF Structure for Archiving TMF Documents Effective CRO Oversight to Ensure Compliance and an Up-to-Date TMF Create, Utilize and Enhance your TMF Process through Metrics Implementation Achieve Maximum Document Quality Through Internal Audits Prepare for Inspection Across Different Regulatory Agencies within a Global Environment Best Practices in Records Management and Paper Archiving Join the TMF professionals to discuss best practices of developing, managing, and monitoring a TMF process that is regulatory compliant for audits and inspections. Who Should Attend: This conference is designed for professionals from pharmaceutical, biotech, medical device, and clinical research with responsibilities in the following areas: TMF and etmf Clinical Operations Document & Record Management Data Archiving Regulatory Affairs Data Management Regulatory Operations Quality Assurance, Operations & Control Knowledge Management Global Planning & Standards Strategic Clinical Operations and Planning Clinical Trial Management Quality Management Informatics Clinical Information Technology AUDIENCE PROFILE BY FUNCTION 25% Clinical Operations 32% TMF/Document/Record Mgmt 14% Quality Assurance/Control 13% Business Development 11% Regulatory Affairs 5% Information Systems We look forward to having Too Much Fun with you this January! Sincerely, Natasia Langfelder Conference Producer, Trial Master File Series ExL Pharma VENUE: KEY BRIDGE MARRIOTT 1401 Lee Highway Arlington, VA Phone: (703) Eric Morrin Business Development Manager, Trial Master File Series ExL Pharma Scott Grossman Division Head, Conference Production ExL Pharma INTERESTED IN SPONSORSHIP & EXHIBITION OPPORTUNITIES? Do you want to spread the word about your organization s TMF, data management or archiving solutions and services to potential clients who will be attend The 4th Trial Master File Summit? Take advantage of the opportunity to exhibit, present an educational session, host a networking event, or distribute promotional items to these industry professionals. ExL works closely with you to customize a package that suits all of your needs. To learn more about these opportunities, contact Eric Morrin, Business Development Manager at or emorrin@exlpharma.com Media Partners Room Reservations: If you require overnight accommodations, please contact the hotel to book your room. ExL Pharma has reserved a block of rooms at a discounted rate for conference participants. We encourage conference participants to make reservations by January 12th, To make reservations guests can call and request the negotiated rate for ExL s January Meetings. Please book your room early as rooms available at this rate are limited. PM36O THE FULL SPECTRUM OF PRODUCT MANAGEMENT

3 AGENDA-AT-A-GLANCE TRIAL MASTER FILE TRAINING DAY - WEDNESDAY JANUARY 21, :00 REGISTRATION OPENS & CONTINENTAL BREAKFAST 9:00 ENHANCE YOUR TRIAL MASTER FILE PROCESS BEFORE, DURING, AND AFTER THE IMPLEMENTATION OF AN ELECTRONIC TRIAL MASTER FILE SYSTEM TRAINING DAY SESSION: DEMYSTIFY ETMF BUSINESS PROCESS MODELING TRAINING DAY SESSION: LEVERAGE KNOWLEDGE MANAGEMENT TO IMPROVE CLINICAL TRIALS TRAINING DAY SESSION: THE CRITICALITY OF CHANGE MANAGEMENT IN ETMF IMPLEMENTATION PROJECTS 4:00 WORKSHOP DAY CONCLUDES TRIAL MASTER FILE DINNER WORKSHOP 5:00 TMF 101: AN INTRODUCTION TO MANAGING THE MOST CRUCIAL CONTENT CREATED IN SUPPORT OF A CLINICAL TRIAL 8:30 DINNER WORKSHOP CONCLUDES MAIN CONFERENCE DAY ONE - THURSDAY JANUARY 22, :30 CO-CHAIR S WELCOME & OPENING REMARKS 8:45 CASE STUDY: PREPARING FOR INSPECTION THROUGH UNDERSTANDING THE LATEST REGULATION REVISIONS 9:30 CASE STUDY: CREATE CROSS-FUNCTIONAL TEAMS FOR ETMF IMPLEMENTATION 10:15 MORNING REFRESHMENTS AND NETWORKING BREAK 10:45 TMF REFERENCE MODEL UPDATE 11:15 A SMALL COMPANY S PERSPECTIVE ON HOW TO ACHIEVE MAXIMUM DOCUMENT QUALITY 12:00 NETWORKING LUNCH 1:00 PANEL DISCUSSION: CREATE, UTILIZE AND ENHANCE YOUR TMF PROCESS THROUGH METRICS IMPLEMENTATION 2:00 DEFINE, SCOPE AND EXECUTE AN ETMF MIGRATION PROGRAM 2:45 NETWORKING BREAK & AFTERNOON REFRESHMENTS 3:15 CASE STUDY: A LOOK INSIDE ALLERGAN S INVESTIGATOR PORTAL INITIATIVE 4:15 ESTABLISHING PROCESSES AND CONTROLS TO ENSURE AN INSPECTION-READY TMF EVERY DAY 5:00 PANEL DISCUSSION: ENSURE A HIGH PERFORMING TMF STRUCTURE FOR ARCHIVING TMF DOCUMENTS 5:45 CONCLUSION OF DAY ONE MAIN CONFERENCE DAY TWO - FRIDAY JANUARY 23, :00 CO-CHAIR S WELCOME & OPENING REMARKS 9:15 EFFECTIVE CRO OVERSIGHT TO ENSURE COMPLIANCE AND AN UP-TO-DATE TMF 10:00 HOW TO MAINTAIN A COMPLIANT TMF ACROSS MULTIPLE GLOBAL SITES 11:00 NETWORKING AND REFRESHMENT BREAK 11:15 CASE STUDY: DEVELOP AN ETMF MENTALITY BY INNOVATING PAPER PROCESSES 12:30 LUNCHEON 1:00 REDUCING THE MANUAL PAPER PROCESS FROM ETMF ADMINISTRATION 1:45 BEST PRACTICES IN RECORDS MANAGEMENT & PAPER ARCHIVING 3:00 NETWORKING BREAK & AFTERNOON REFRESHMENTS 2:45 INTERNATIONAL CASE STUDY: HOW TO ACHIEVE THE BEST RESULTS IN DOCUMENT SUBMISSION FROM A CRO 3:30 PANEL DISCUSSION: HARMONIZE TMF PRACTICES ACROSS ALL CLINICAL TRIAL SITES TO ENSURE TMF CONSISTENCY 5:00 CONFERENCE CONCLUSION

4 WEDNESDAY, JANUARY 21, 2015 TRIAL MASTER FILE TRAINING DAY 8:00 Registration Opens & Continental Breakfast 9:00 ENHANCE YOUR TRIAL MASTER FILE PROCESS BEFORE, DURING, AND AFTER THE IMPLEMENTATION OF AN ELECTRONIC TRIAL MASTER FILE SYSTEM Professionals involved in paper and/or electronic TMF content recognize the importance of fully understanding all aspects and benefits of creating a consistent TMF structure supported by a high functioning TMF management process and all aspects involved in managing a high-performing TMF structure. This full day interactive workshop will provide attendees with the three main aspects of the TMF management process. Defining Effective TMF Business Processes, Infusing Knowledge Management into the Goals of the Project and Exploring your Strategies for Change Management that are Critical to make Both Successful: DEMYSTIFY ETMF BUSINESS PROCESS MODELING This session of the workshop drills down into a few key etmf business process model. Designing acurrate as-in and future business process maps is a difficult task since the etmf infuses new ways of working. However, they are a vital part of ensuring the etmf implementation project s success. xxdefine what an etmf process map is and the multiple levels at which it needs to be created. xxlearn how to put a business process plan into place and reasons it is critical to an etmf implementation project xxwork together to create 2-3 key business process maps that can be applied to your current TMF management processes. LEVERAGE KNOWLEDGE MANAGEMENT TO IMPROVE CLINICAL TRIALS The data inside your TMF is vital to your clinical trial. However, few use this data to its complete full potential. This second session of the workshop takes the TMF beyond inspection readiness. Harness it s power to impact business process. This interactive session explores how to apply metadata that is captured in the TMF to better manage the clinical trial and even clinical development programs. xxlearn to look at your etmf like you never have before. xxuse metadata captured on your etmf content to analyze and make tactical decisions for your company xxapply concepts to start the process of using metadata to impact decisions about study execution THE CRITICALITY OF CHANGE MANAGEMENT IN ETMF IMPLEMENTATION PROJECTS Technology implementation rapidly changes the landscape of deeply engrained processes and an etmf implementation is no exception. This interactive session of the workshop explores how to navigate the choppy waters of how to manage organization change in an etmf implementation project xxexplore why a fully flushed out change management plan is critical to an etmf implementation project xxassess the major milestone of etmf implementation project and the change management concepts that apply to each xxcreate a high level change management plan based on session exercises that can be applied when returned to the office to effectively communicate impact of the introduction and utilization of new technologies Training Day Leader: Lisa Mulcahy, Co-Leader, TMF Reference Model Team, Owner and Principal Consultant, MULCAHY CONSULTING, LLC Workshop Session Leaders: Business Process: Alex Markiel, Senior Manager, Clinical Systems, BIOMARIN Knowledge Management: Jane Twitchen, Associate Director of Records Systems and Operations, BIOGEN IDEC Change Management: Eldin Rammell, Consultant, RAMMELL CONSULTING This workshop will have a one-hour break for a networking lunch and two 30-minute breaks. 4:00 Workshop Day Concludes TMF FOR BEGINNERS 5:00 Dinner Workshop TMF 101: AN INTRODUCTION TO DEFINING AND MANAGING THE CONTENT CREATED IN SUPPORT OF A CLINICAL TRIAL This dinner workshop is geared towards those who were either recently hired into the TMF field and those who are looking to further their career. Workshop leaders will introduce you to the Trial Master File and the many challenges that TMF professions face. You will learn: xxthe Trial Master file, it s definition, it s content, and who creates it. xxthe evolution of TMF regulations that govern the management of the TMF xxunderstand the TMF lingo- how to talk to your new peers Lisa Mulcahy, Co-Leader, TMF Reference Model Team, Owner and Principal Consultant, MULCAHY CONSULTING, LLC Molly Salyers, Regulatory Affairs Specialist, CYTRX CORPORATION This workshop will provide dinner and refreshments 8:30 Dinner Workshop Concludes

5 THURSDAY, JANUARY 22, 2015 MAIN CONFERENCE DAY ONE 8:00 Registration and Continental Breakfast 8:30 CHAIRPERSONS OPENING REMARKS Karen Roy, Global Business Development Director, Ivan Walrath, Trial Master File Process Owner, PFIZER Vinita Leslie, Director, Trial Master File Process Owner, Regulatory Operations, BIOGEN IDEC 8:45 CASE STUDY: PREPARING FOR INSPECTION THROUGH UNDERSTANDING THE LATEST REGULATION REVISIONS xxreview the updated definition of a critical GCP inspection finding xxexplore the current trends in regulations and what to expect for the future xxunderstand the TMF as critical to regulatory and legal compliance Ivan Walrath, Trial Master File Process Owner, PFIZER CASE STUDY 9:30 CASE STUDY: CREATE CROSS-FUNCTIONAL TEAMS FOR ETMF IMPLEMENTATION xxcommunicate expectations and responsibilities up-front xxestablish who will be held accountable for which parts of the project xxdevelop and encourage individuals within the team to play to their strengths to achieve a smooth roll-out Lisa Rakebrand, Associate Director, Clinical Trials, JANSSEN CASE STUDY 10:15 Morning Refreshments and Networking Break 10:45 TMF REFERENCE MODEL UPDATE xxthis discussion will fill you in on the latest information about activities and plans for the TMF Reference and OASIS etmf Interoperability models xxtmf Reference Model adaption: adding types, recommended vs core, differentiating metadata in etmf, etc. xxconsiderations for TMF alignment Karen Roy, Global Business Development Director, 11:15 ACHIEVE MAXIMUM DOCUMENT QUALITY THROUGH INTERNAL AUDITS xxremain inspection ready 24/7 through instituting internal audits xxleverage experienced personnel to run the audits xxgain buy-in through real-time consequences if the internal audit fails Curran Murphy, Clinical Project Manager, CERULEAN PHARMACEUTICALS 12:00 Networking Lunch 1:00 PANEL DISCUSSION: CREATE, UTILIZE AND ENHANCE YOUR TMF PROCESS THROUGH METRICS IMPLEMENTATION xxunderstand the process improvement metrics has on YMF collection and monitoring xximplementation metrics to reforming key performance indicators xximplement a global metrics and monitoring platform xxbenefits and drawbacks to traditional benchmarks and metrics Linda Sullivan, Chief Operating Officer, METRICS CHAMPION CONSORTIUM Vinita Leslie, Director, Trial Master File Process Owner, Regulatory Operations, BIOGEN IDEC PANEL DISCUSSION 2:00 DEFINE, SCOPE AND EXECUTE AN ETMF MIGRATION PROGRAM xxmove beyond TMFs stored in a vanilla SharePoint or Documentum system, or an earlier generation legacy etmf xxdefine clear goals of the migration that govern the migration scope, timeframe and other important variables xxspecify content within the migration versions, document statuses, etc. xxmigrate or archive an audit trail to ensure compliance xxdevelop a cost-benefit analysis to avoid increases in scope and cost Kathie Clarke, etmf Product Manager, WINGSPAN 2:45 Networking Break & Afternoon Refreshments 3:15 CASE STUDY: A LOOK INSIDE ALLERGAN S INVESTIGATOR PORTAL INITIATIVE xxhear how Allergan took control of the document collecting process through an investigator portal initiative xxtake steps to improve investigator retention and streamline trial administration xxlearn how to create a productive sponsor relationship with Trancelerate s Investigator Portal Sukh Chugh, Director, R&D IS, ALLERGAN PANEL DISCUSSION CASE STUDY 4:00 ESTABLISHING PROCESSES AND CONTROLS TO ENSURE AN INSPECTION-READY TMF EVERY DAY xxtwo case studies from organizations describing their approach, and what they implemented, to achieve inspection-ready TMFs xxhow to use remote access to provide internal and external parties with the appropriate level of access to submit, collect, QC, and approve trial documents to achieve direct trial access xxsteps to make the etmf 21 CFR Part 11 compliant as the official repository for all electronic records and electronic signatures xxhow to minimize the filing burden for content from external parties xxhow to fulfill the critical aspects of inspection readiness without requiring significant new resources Jason Methia, Product Specialist, VEEVA 4:45 PANEL DISCUSSION: ENSURE A HIGH PERFORMING TMF STRUCTURE FOR ARCHIVING TMF DOCUMENTS xxearchiving of paper based documents xxdeveloping complex filing systems for larger trials that have more documents xxthe proper length of time to keep documents- including those that are non-study specific Donald Palmer, Associate Director, Regulatory Systems, MEDIMUNNE Lisa Rakebrand, Associate Director, Clinical Trials, JANSSEN Carol Stotesbury, TMF Manager, GILEAD SCIENCES 5:45 Conclusion of Day One 5:45 COCKTAIL RECEPTION For exclusive branding opportunities at this unique networking event please contact Eric Morrin at emorrin@exlpharma.com THERE ARE REALLY NO OTHER TMF/ETMF CONFERENCES- VERY USEFUL TO GET TOGETHER WITH OTHERS WORKING IN THE SAME AREA AND TO SEE THE VENDORS/ SERVICES AVAILABLE Director Clinical Operations, Janssen GREAT INFORMATION ON INSPECTION READINESS, STRATEGIC RELATIONSHIPS & TMF OVERSIGHT- GREAT LESSONS LEARNED Assistant Director, Abbvie

6 FRIDAY, JANUARY 23, 2015 MAIN CONFERENCE DAY TWO 7:45 Registration Opens & Continental Breakfast 8:30 CHAIRPERSONS OPENING REMARKS Karen Roy, Global Business Development Director, Ivan Walrath, Trial Master File Process Owner, PFIZER Vinita Leslie, Director, Trial Master File Process Owner, Regulatory Operations, BIOGEN IDEC 8:45 EFFECTIVE CRO OVERSIGHT TO ENSURE COMPLIANCE AND AN UP-TO-DATE TMF xxmanage the flow of trial information between sponsor and CRO xxensure inspection ready files through effective communication and quick turn around of critical documents xxdevelop an internal set of SOPs to harmonize the TMF when outsourcing to multiple CROs Wendy Trimboli, Associate Director, TMF Process Management and Quality Control, Global Regulatory Operations, GRA, EISAI 9:30 REDUCING THE MANUAL PAPER PROCESS FROM ETMF ADMINISTRATION xxautomated Distribution and Collection of Electronic Site Files xxbulk Routing of Wet Ink Sig s from Sites xxbulk Uploading and Indexing Capabilities xxautomating the QC Process According to Your Risk Tolerance xxstandardizing your process to ensure a quality, inspection-ready TMF Brian Mundy, epharmaone Product Manager epharmasolutions 10:15 CASE STUDY: DEVELOP AN ETMF MENTALITY BY INNOVATING PAPER TMF PROCESSES xxhear Forest Research Institute s approach for creating an etmf mindset by integrating the look and feel of etmf into current paper processes xxcase studies of three process improvements will be demonstrated Eric Rubinson, Director, Regulatory Affairs Operations, FOREST LABORATORIES CASE STUDY 11:00 Networking and Refreshment Break 11:30 EXPERIENCE WITH ETMF & SITE ARCHIVING xxedm and etmf - where are we now regarding recent EMA and FDA regulation changes and the TMF reference model xxinvestigative Site Challenges- explore the benefits to electronic submission and overcome the hurdles in learning a new, more efficient system xxtechnology and study coordinator population research xxhow to streamline study management and quantify the benefits to electronic data collection from feasibility to archive xxsmall case study presentation xxwhat can we implement now and tips on getting started Shannon Cooke, Project Manager, TRANSPERFECT 12:30 Luncheon 1:30 CASE STUDY: HOW TO MAINTAIN A COMPLIANT TMF ACROSS MULTIPLE GLOBAL SITES xxstay organized during initial setup, maintenance & archiving for outsourced studies xxestablish communication with international clinical sites and navigate through cultural, lingual and time zone differences xxtried and true methods to obtain the signatures that are crucial to the TMF throughout the study Andrew Waite, Director, Records and Information Management, AMGEN CASE STUDY CASE STUDY 2:15 BEST PRACTICES IN RECORDS MANAGEMENT AND PAPER ARCHIVING x x Good Record Keeping what does it mean for you? xxthe overlap between etmf management and paper TMF management are they that different? xxfiling and retention of paper documents Betsy Fallen, Former Director, Site Ready and Clinical Development Operations, MERCK 3:00 Networking Break & Afternoon Refreshments 3:30 CASE STUDY: HOW TO ACHIEVE THE BEST RESULTS IN DOCUMENT SUBMISSION FROM A CRO xxidentify and develop strategic KPIs xxwork regionally with CROs in LATAM and discuss expectations xxincrease communication executive meeting with upper management from CRO to share results Fabio Rodrigues, Clinical Operations Manager, BOEHRINGER INGELHEIM 4:15 PANEL DISCUSSION: HARMONIZE TMF PRACTICES ACROSS ALL CLINICAL TRIAL SITES TO ENSURE TMF CONSISTENCY xxmanaging TMF s from multiple trials sites is a juggling act, one that is made even more difficult if sites are labeling and filing documents differently xxbest practices for initiatives to encourage harmonization in labeling and filing xxcommunication and training strategies to achieve these goals Moderated by Karen Roy, Global Business Development Director, Ivan Walrath, Trial Master File Process Owner, PFIZER Fabio Rodrigues, Clinical Operations Manager, BOEHRINGER INGELHEIM Wendy Trimboli, Associate Director, TMF Process Management and Quality Control, Global Regulatory Operations, GRA, EISAI PANEL DISCUSSION 5:00 Chairpersons Closing Remarks and Conference Conclusion EXCELLENT CONTENT & PRESENTATIONS Director Clinical Operations, Janssen VERY ENGAGING DOWN-TO-EARTH, REAL ISSUES AND SOLUTIONS Clinical Operations, Alkermes VERY NICE AGENDA - COVERING MANY ASPECTS WITH TIME ALLOTTED TO DISCUSSION AND Q&A TMF Process Owner, Novo Nordisk AWESOME INFORMATION, IT WAS GREAT TO HEAR THE REAL LIFE EXPERIENCES FROM THOROUGH, FORWARD THINKING, RESPONSIBLE COMPANIES/TEAMS Director, Advanced Clinical

7 GOOD STRONG POINTS, WILL REFER BACK TO PRESENTATIONS FOR USE ON THE JOB Clinical Operations, Biogen Idec GREAT TIPS FOR PREPARING THE TMF FOR AUDITING Clinical Affairs, BARD PRESENTERS PROVIDED INTERESTING, HELPFUL INFORMATION Associate Director, Janssen I THINK THE PRESENTATIONS THIS YEAR WERE IMPROVED VERY USEFUL IN TERMS OF GETTING INSIGHT INTO HOW OTHER COMPANIES MANAGE ETMF TMF Admin, Biogen Idec GOOD INFORMATION ON HOW BIG PHARMA FRAME WORK CAN HELP THE SET UP OF SMALL PHARMA Clinical Trial Specialist, Endo Pharmaceuticals REGISTRATION INFO EARLY BIRD PRICING* STANDARD PRICING* ONSITE PRICING* To take advantage of Early-Bird Pricing register by Friday, December 5, 2014! Conference + 1 day Seminar: $2495 $2695 $2795 Conference + Dinner Workshop: $2295 $2495 $2595 Conference Only: $1895 $2095 $2195 GROUP DISCOUNT PROGRAMS: *Offers may not be combined. Early Bird rates do not apply* Save 25% 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% Can only send three? You can still save 15% off of every registration. Payment: Make checks payable to ExL Events, Inc. and write code C535 on your check. You may also use Visa, MasterCard, Discover or American Express. Payments must be received in full by the conference date. Any discount applied cannot be combined with any other offers and must be paid in full at the time of order. Parties must be employed by the same organization and register simultaneously to realize group discount pricing options. Group discounts available to individuals must be registered simultaneously and employed by the same organization. **Please note, there will be an administrative charge of $300 to substitute, exchange and/or replace attendance badges with a colleague occurring within five business days of any ExL conference.** 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 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 Pharms 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.

8 Yes! Register me for the Conference + 1 Day Seminar Yes! Register me for the Conference + Dinner Workshop Yes! Register me for the Conference Method of Payment: Check Credit Card Make checks payable to pmaconference Card Type: o MasterCard o Visa o AMEX Please contact me: I wish to receive updates on ExL Pharma's upcoming events Card Number: Name on Card: Exp. Date: Name: Title: Signature: Company: Dept: Conference Code: C535 Address: City: State: Zip: Phone: Fax: 4TH JOIN THE TRIAL MASTER FILE FAMILY! BUILD LASTING RELATIONSHIPS AT THE ONLY CONFERENCE DEDICATED TO PAPER AND ELECTRONIC TMF TRIAL MASTER FILE SUMMIT January 21-23, 2015 / KEY BRIDGE MARRIOTT / ARLINGTON, VA I AM SO GLAD TO HEAR THE ISSUES WE EXPERIENCE, OTHERS EXPERIENCE Clinical Trial Specialist, Endo Pharmaceuticals THE MOCK INSPECTION RECOMMENDATIONS WERE VERY INFORMATIVE Documentation Group Manager, Actelion BEING AN ETMF VENDOR IMPLANTATION CONSULTANT, THIS WAS A GREAT LEARNING OPPORTUNITY Consultant, Nextdocs REALISTIC & USEFUL INFORMATION IMPARTED Associate Director, Biogen Idec EXCELLENT PERSPECTIVES ON THE BASICS AND PURPOSE OF TMF TO SUPPLY DRUG DELIVERY TO MARKET Principal Consultant, Paragon Solutions GREAT CHOICE OF PANELISTS, GREAT DIVERSITY OF VIEWS Regulatory Strategist, PATH