trial master file summit - exl eventsinfo.exlevents.com/rs/195-ner-971/images/c837_web.pdf ·...

THE 2017 TMF SUMMIT FEATURES:

d 30+ educational sessions encompassing everything you need to know about the TMF process

d 15+ hours of networking with 200+ TMF professionals

d Unique case studies from industry leaders that you can’t hear anywhere else

d A team development/employee development dinner where TMF professionals can hone their skills while networking

d A preconference seminar to further improve your TMF process knowledge

d An introductory TMF workshop for all industry newcomers

d Three panel discussions that will prepare you for your next inspection, improve your document management system and ensure consistency

SPONSORED BY:

Ensure TMF Completeness Through SOP Creation, Data Management, Strong Partner Communication and Inspection Readiness

January 17-19, 2017 / Loews Royal Pacific Resort at Universal Orlando / Orlando, FL

TRIAL MASTER FILE SUMMIT

“CAN’T WAIT FOR NEXT YEAR’S EVENT TO HEAR HOW TMF HAS DEVELOPED.”—Director, Clinical Study Management, ASTELLAS

FABIO RODRIGUESHead of TMF in LATAM, BOEHRINGER INGELHEIM DO BRASIL

SHOLEH EHDAIVAND President and CEO, LMK CLINICAL RESEARCH CONSULTING

BETSY FALLEN Global Head of Program and Business Development, SAFE-BIOPHARMA ASSOCIATION

JENNIFER O’REILLY Clinical Trials Project Manager, PATH’S CENTER FOR VACCINE INNOVATION AND ACCESS (CVIA)

ALEX MARKIEL Associate Director, Development Sciences Quality, BIOMARIN PHARMACEUTICAL INC.

JASON METHIA Vice President, Vault Study Startup, VEEVA SYSTEMS

LAURA NARANJO Manager, TMF Operations, DAIICHI SANKYO

DAWN NICCUM Associate Director, Quality, ENDOCYTE

JENNIFER POULAKOS Director, Development Quality Assurance, AGENSYS INC, AN AFFILIATE OF ASTELLAS PHARMA, INC.

KAREN ROY Senior Vice President, Client Solutions, PHLEXGLOBAL

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ERIC RUBINSON Director, Regulatory Affairs Operations, ALLERGAN

KATE SANTORO Clinical Trial Manager, Clinical Systems and Documentation, ALKERMES

WENDY KELLY Manager, Global Development Administration, SUNOVION PHARMACEUTICALS INC.

LINDA B. SULLIVAN Co-Founder and President, METRICS CHAMPION CONSORTIUM LLC

JAMIE TOTH Head of TMF Operations, DAIICHI SANKYO

TM

T r u e e - I n t e g r a t i o n . A s i n g l e p o r t a l .

200+ Conference Attendees

40+ Expert Speakers

30+ Educational Sessions

#1

Event Worldwide

For more information please visit www.exlevents.com/TMF or call 866-207-6528

Dear C ol league, Do you feel like integrating a TMF is overly complicated?

Do you wish that you and your team had cohesive training on TMF implementation?

Have you ever worried about strategically choosing the right partnerships with CROs and sites to suit your needs?

Are you concerned about how your organization will prepare for its next inspection?

Do you think there are ways to optimize your TMF process?

You are not alone! For six years now, we here at ExL Events have brought together TMF

professionals from all over the world to discuss and resolve these issues, along with

other pressing challenges that plague the industry today. Hundreds of people have

attended events in our Trial Master File Series, which spans three continents, and have

gone back to their organizations armed with the tools they needed to improve their

overall processes.

As the organizers of the world’s largest gathering of TMF professionals, we pride

ourselves on facilitating the discussions that drive the field forward. Industry leaders

share their own personal experiences in order to further the collective cause of

improving the health of patients all around the globe. If you feel that there is room for

improvement for your team and your organization, then this is the place to be in January.

Come and hear unique case studies, panel discussions and training workshops from

some of the leading TMF professionals in the industry. With the all-star cast that the 6th

Trial Master File Summit boasts, this will surely be an event you will not want to miss.

We look forward to welcoming you to warm and sunny Florida in January!

Sincerely,

Scott Grossman

Division Head, Conference Production ExL Events, a Division of Questex, LLC [email protected]

WHO SHOULD ATTEND: This conference is designed for representatives from pharmaceutical, biotech, medical device and clinical research companies with responsibilities in the following areas:

d ● TMF and eTMF

d ● Clinical Research

d Document Management

d ● Clinical Document/Data Management

d ● Clinical Trial Administration/Management

d ● Quality Assurance/Control/Operations

d ● Strategic Operations and Planning

d ● Clinical/Project Operations

d ● Regulatory Affairs

d ● Clinical Document Coordination

d ● Clinical Development

d ● Clinical Study/Records Management

d ● Regulatory Compliance/Operations

d ● Regulatory Affairs

d ● Records/Information Management

d ● Documents and Records

d ● Good Clinical Operations

d ● Strategic Operations and Planning

d ● Informatics

d ● Clinical IT

This event is also of interest to:

d ● eTMF Service Providers

d ● TMF Consultants

d CROs

d ● Electronic Signature Service Providers

d ● Paper and Electronic Data Archiving Service Providers

d ● Data/Records Management Service Providers

HOTEL INFORMATION LOEWS ROYAL PACIFIC RESORT AT UNIVERSAL ORLANDO6300 Hollywood WayOrlando, FL 32819

If you require overnight accommodations, please contact the hotel. ExL has reserved a block of rooms at a group rate. To make reservations, please call 866-360-7395 and request the group rate for the 6th Trial Master File Summit. The group rate is available until Tuesday, December 27, 2016. You can also make reservations online by visiting http://bit.ly/2crKLQe. Please book your room early, as rooms available at this rate are limited.

*ExL Events is not affiliated with Exhibition Housing Management (EHM)/Exhibitors Housing Services (EHS) or any third-party booking agencies, housing bureaus or travel companies. ExL Events is affiliated with event company Questex, LLC. In the event that an outside party contacts you for any type of hotel or travel arrangements, please disregard these solicitations, and kindly email us at [email protected]. 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.

SPONSORSHIP AND EXHIBITION OPPORTUNITIESSpread the word about your organization’s solutions and services to potential clients who will be attending this event. Take advantage of the opportunity to exhibit, underwrite an educational session, host a networking event or distribute promotional items to attendees. ExL Events will work closely with you to customize a package that will suit your marketing and business development needs and budget. To learn more, please contact Eric Morrin at 212-400-6228 or [email protected].


6TH


7:30 Registration Begins

8:00 TMF 101: Decoding the Trial Master File – the Basics of Who, What, Where, When, Why and How It Needs to Be Actively Managed

The management of the TMF, and the content created in support of a clinical study, can be complicated. There are so many contributors with many different opinions on what is in the TMF, the locations that are acceptable to hold the content, when it has to be there and how it is to be managed. This workshop is geared toward those who are new to the TMF field, though professionals at all levels of experience can benefit from attending.. The concepts addressed will give attendees the foundation they need to get the most out of this conference. Experienced workshop leaders will introduce the TMF, review the many challenges that TMF professionals face, and help attendees start or continue to develop the confidence needed to best perform their day-to-day responsibilities. The workshop will address the following:

g The TMF, its definition, its complexity and simplicity, and the requirements for management by those that create, collect and also manage the TMF g The TMF Reference Model and how it can be used it to support solid TMF management processes g At a high level, the guidances, laws and regulations that govern the TMF in the US, the EU and Japan

Lisa Mulcahy, Owner and Principal Consultant, MULCAHY CONSULTING, LLCCurran Murphy, Associate Director, Clinical Operations, CERULEAN PHARMA

This breakfast workshop will include a 30-minute break.

11:00 TMF 101 Concludes

11:30 OPERATIONALIZE YOUR TMF TO ENSURE INSPECTION READINESS SUCCESS

The Trial Master File (TMF) is the foundation of every clinical trial. With that foundation, it is essential that TMF stakeholders ensure all aspects of a trial are continuously monitored and of the highest quality in order to ensure inspection readiness. The TMF life cycle can be enhanced by effectively planning, collecting and maintaining clinical trial documents on an ongoing basis. Through the use of TMF metrics, stakeholders will be able to monitor and understand the health of the TMF in real time.

One way to ensure inspection readiness is to operationalize your TMF by developing a structure from study design to archiving. This allows for standards, operating procedures, content collection and quality assurance practices to be put in place. It is important to create a strong foundation in order to have an inspection-ready TMF. From TMF setup through closeout, attendees can expect to learn best practices for how to maximize their processes to ensure they are inspection-ready on day one while:

g Hearing best practices for achieving document quality through established, defined criteria g Understanding the holistic approach to TMF completeness through functional line engagement g Developing, maintaining and properly measuring techniques for measuring TMF health

Sholeh Ehdaivand, President and CEO, LMK CLINICAL RESEARCH CONSULTINGMarie-Christine Poisson-Carvajal, TMF Operations Lead, PFIZER

This seminar will contain a 45-minute lunch and a 30-minute networking break.

4:30 Seminar Concludes

5:00 THE TMF MANAGEMENT DEPARTMENT: The “Ins and Outs” of the Team that Prioritizes the TMF Management Process

Solid TMF management is critical to the success of biopharmaceutical and device R&D companies. However, the TMF often gets shortchanged when it comes to prioritization and resource allocation. Successful companies have established the justification for a group, a function and a department, which oversees the process and makes the TMF its first priority.

To start the establishment of the group there has to be the argument for the need; an organizational chart with job descriptions; and a solid, defined scope of responsibilities. As these departments are very important to the overall success and quality of the TMF, there is a direct need to design a structure to support the TMF process. During this workshop attendees will learn from industry leaders who have been successful in designing a TMF department that can directly support the management of TMF files. Additionally, attendees will learn through presentations and group exercises while gaining the tools needed to support:

g Providing the justification for the need of a TMF management structure and team g Estimating the number of resources for a local and global team g Establishing position titles, associated responsibilities and career paths to support these professionals g Leveraging resources and tips when hiring the perfect person with the right personality characteristics and professional experiences

Lisa Mulcahy, Owner and Principal Consultant, MULCAHY CONSULTING, LLCAlex Markiel, Associate Director, Development Sciences Quality, BIOMARIN PHARMACEUTICAL INC.

8:00 TMF Dinner Concludes

2017 Workshop/Training DayTuesday, January 17, 2017

“A LOT OF TAKEAWAYS FROM THESE PRESENTATIONS. VERY KNOWLEDGEABLE PRESENTERS, AND VERY HELPFUL TO VIEW FEEDBACK.”—Clinical Document Management Specialist, CR BARD

“GREAT CASE STUDIES, VERY PRACTICAL AND APPLICABLE.”—TMF Specialist, BIOMARIN

“EXCELLENT CONTENT AND PRESENTATIONS, THE SPEAKERS WERE VERY ENGAGING.”—Associate Director, JANSSEN R&D

“ENGAGING AND POSITIVE SPEAKERS WITH A LOT OF ENERGY!”—Senior Trial Documentations Specialist, ACTELION

TMF 101WORKSHOP

TMF DINNER

TMFSEMINAR


8:00 Continental Breakfast and Registration Begins

8:30 Chairpersons’ Opening RemarksKaren Roy, Senior Vice President, Client Solutions, PHLEXGLOBALJamie Toth, Head of TMF Operations, DAIICHI SANKYOEric Rubinson, Director, Regulatory Affairs Operations, ALLERGAN

8:45 Process Changes When Moving From Paper to eTMF g Discuss workflows to support timely filing and reduce effort g Analyze how to efficiently change your process to optimize productivity g Learn new strategies to plan ahead and continue to improve your process

Martina Duevel, Senior GCPM ONC, eTMF Process Owner Representative, BAYER

9:30 CASE STUDY: Change Management and Its Impact on eTMF Implementation

g Write a project plan/justification to obtain support for eTMF implementation g Bring teams on board with the TMF Reference Model and system g Develop a process for transferring ongoing studies into the eTMF solution g Utilize metadata to impact searching efficiency g Use the eTMF solution to efficiently submit documents as soon as possible g Collaborate with teams to keep TMFs current

Jennifer Poulakos, Director, Development Quality Assurance, AGENSYS INC, AN AFFILIATE OF ASTELLAS PHARMA, INC.Sherri Richardson, Senior Development QA Associate II, AGENSYS INC, AN AFFILIATE OF ASTELLAS PHARMA INC.

10:15 How Active Is Your Trial Master File? Benchmarking the Industry g Understand the difference between passive and active TMF management g Review an analysis of more than 90 Veeva TMF Maturity Model evaluations taken over the last year

g Examine key metrics to help evaluate and monitor TMF performanceJason Methia, Vice President, Vault Study Startup, VEEVA SYSTEMS

10:45 Networking Break

11:15 CASE STUDY: Acquisitions, Collaborations and Divestitures (ACDs) and Their Implications on a TMF

g Meet legal contractual obligations, planned project timelines and timing of planned ACD activities

g Confirm elements applicable to TMF, as they drive the appropriate process and decisions for integration

g Debate the format of the TMF — e.g., paper, electronic or combination — and how it should be integrated

g Evaluate important factors for confirming a complete and healthy TMF prior to divestiture

Brenda R. Brown, TMF Business Support and CAPA Management Lead, PFIZER

11:45 The Inspection Report Aftershock and What Happens Now g Discuss best practices for evaluating and responding to your inspection report g Assess what inspection findings really mean g Obtain the most from your teams through remediation planning g Determine which observations to fix first through action planning and a review process

g Engage your stakeholders through strategy, execution and capability building g Learn when and how to reach outside your organization for help g Discover common inspection findings related to TMF management

Chris Seifarth, Director, Client Solutions, PHLEXGLOBAL

12:15 Networking Lunch

1:15 PANEL DISCUSSION: Using Metrics and Benchmarks to Improve TMF Management

g Define the TMF g Identify the right set of TMF metrics for your organization g Leverage metrics to improve the process g Address resource challenges in smaller organizations

Linda B. Sullivan, Co-Founder and President, METRICS CHAMPION CONSORTIUM LLCBrenda R. Brown, TMF Business Support and CAPA Management Lead, PFIZERWendy Kelly, Manager, Global Development Administration, SUNOVION PHARMACEUTICALS INC.Alexandra Miller, Clinical Research Associate, In-House, BLUEBIRD BIO

2:00 Improve Clinical Trial TMF Quality Based on a Clearly Designed TMF Format, Processes and Procedures

g Adopt best practices to keep a steady flow in your document management stream

g Improve internal procedures and set expectations for timely management for the entire team

g Maintain high-quality documents while also decreasing errors in processing files g Create an effective QC process g Perform quality checks at regular intervals to ensure a healthy and robust TMF at all times

g Track metrics and performance to see where things can be more efficientWendy Trimboli, Associate Director, TMF Process Management and Quality Control, Global Regulatory Operations, MDC, EISAI INC


eTMF Implementation Metrics and Quality

3:15 TMF Management: Beyond Document Management g Discover how TMF management includes but is not limited to document management

g Receive tips on configuring an electronic document management system (EDMS) to manage TMF artifacts and metadata

g Recognize product management’s role in TMF management g Suggest uses for metadata to facilitate the access and sharing of TMF content with third parties (e.g., CROs, sponsors, sites)

Patricia Santos-Serrao, RAC, Director, Clinical and Regulatory Solutions Pharmaceutical, Blood and Biologics, MASTERCONTROL

Create an eTMF Structure and Implement Quality Process Improvement Strategies g Create a checklist of things you need in your eTMF process g Set up an infrastructure that can support your needs and develop further for legacy trials g Employ lessons learned from previous trials to benchmark your quality process

Kate Santoro, Clinical Trial Manager, Clinical Systems and Documentation, ALKERMES

4:00 Improve Your Implementation Process by Planning It Out in Advance g Establish procedures and train your team on all aspects of the implementation process

g Identify the necessary considerations that can affect trial outcomes and their quality g Perform due diligence and create a strong document filing plan

Evelin Baez, Clinical Document Management Specialist, C.R. BARD

Determine the Impact of Governance and Metrics on Compliance and Utilize Them to Improve Efficiency

g Adopt metrics to measure the health of your eTMF g Improve the quality and efficiency of your TMF process through the use of metrics and benchmarking

g Track valuable data to ensure you are inspection-ready at all times g Ensure the quality and completeness of your eTMF

Dawn Niccum, Associate Director, Quality, ENDOCYTE4:30 CASE STUDY: Implementation and Maintenance of a Homegrown

Document Retention System g Address overall system management g Review benchmarking and lessons learned g Discuss staff enhancements g Incorporate technical maintenance, storage, back-up and archiving g Analyze SharePoint platform migration

Shannon A. Simpson, M.S., CCRP, Clinical Trials Documentation and Regulatory Specialist, PATH’S CENTER FOR VACCINE INNOVATION AND ACCESS (CVIA)Jennifer O’Reilly, Clinical Trials Project Manager, PATH’S CENTER FOR VACCINE INNOVATION AND ACCESS (CVIA)

Utilization of Six Sigma Tools to Evaluate Internal TMF Staff Performance for Quality Checks

g Utilize Measurement Systems Analysis (MSA) to validate the quality check process g Detect and solve internal variation work in a TMF during the quality check g Analyze the use of Six Sigma to standardize the quality check process g Implement actions to avoid internal variation caused by employees on the document quality check process

Fabio Rodrigues, Head of TMF in LATAM, BOEHRINGER INGELHEIM DO BRASILCatharine Espanhol, TMF Coordinator in LATAM, BOEHRINGER INGELHEIM DO BRASIL

5:00 Networking Reception 6:00 Conclusion of Main Conference Day One

Main Conference Day One Wednesday, January 18, 2017

CRO/Site Partnerships Document Management and Inspection Readiness

8:45 Chairpersons’ Opening Remarks Chairpersons’ Opening Remarks

9:00 Best Practices for Effective Partnership Management and Oversight for All Stakeholders

g Communicate efficiently with all partners involved in managing and maintaining a TMF system

g Develop a Center of Excellence to provide oversight for all stakeholders, including TMF content owners

g Provide support and guidance to all stakeholders to maintain compliance with related procedural documents

Ronak Kadakia, Manager, TMF Analyst and Central Import, JANSSENStacy Jandciu, Manager, TMF Compliance Specialists, JANSSEN

PANEL DISCUSSION: Expectations When Preparing for a TMF Inspection — Follow the Trends and Remain Compliant

g Navigate the different regulatory authorities from all over the world g Strategize with your team on best practices for keeping your TMF healthy throughout the entire life cycle of a clinical trial

g Analyze past trends and look into the future to determine common breakdown points and how to avoid them

g Employ mock inspections and audits to ensure you are constantly ready for an inspection g Follow GCP standards at all times to stay ahead of the game g Discuss the expectations that come with a regulatory inspection of an eTMF

Amer Alghabban, Vice President GxP Quality Assurance, Compliance Training, KARYOPHARM THERAPEUTICS Cassandra Schroeder, Senior Clinical Trials Associate, INTERCEPT PHARMACEUTICALS Erin Babcock, Senior Manager, Clinical Operations, INTERCEPT PHARMACEUTICALS Andrew Waite, Director, AMGEN

9:45 CRO-Managed TMF and Effective Preparation for Inspection g Learn how to work effectively with a CRO as they run the trial TMF, and remain inspection-ready

g Identify the unique benefits that can be attained from working with multiple CROs g Set expectations beforehand to create a harmonious working environment with all partners and ensure you are ready when an inspector comes knocking at your door

Lauren Lockhart, Site Management Consultant

Improve TMF Documentation by Addressing Functional Filing and Capture Issues g Overcome filing issues and errors with a Good Document Practice (GDP) plan g Utilize a process and platform for trial sites and CRO management and oversight g Steps to maintain a unified GDP over multiple partner relationships g Explore lessons learned when addressing functional filing issues

James Peters, Director of Professional Services, DATA REDUCTION SYSTEMS CORPORATION

10:15 Sponsor Considerations When Deciding Whether to Use Their Own or Their CROs’ eTMFs

g Impact on cost and quality g Ability to provide due diligence and oversight g Ability to ensure records retention for your organization g Support for health authority inspections g Need for validated document transfer mechanisms

Kathie Clark, Vice President, Product Management, WINGSPAN TECHNOLOGYKelley Robinson, Senior Information Manager, Content Management and Authoring, PFIZER

CASE STUDY: Deep Dive into the TMF Plan and Why You Need One g Understand the basics of the TMF plan and why it’s important g Discuss the key components and decisions that need to be made ahead of receiving the first start up documents

g Learn how to integrate a CRO’s TMF processes into a sponsor’s TMF processes g Develop a collaborative plan to ensure a successful TMF

Jamie Toth, Director and Head of TMF Operations, Clinical Development Operations Function, DAIICHI SANKYO

8:00 Registration Opens and Continental Breakfast


11:15 CASE STUDY: To Migrate or Not? Preparing People, Process and Technology for the Great Migration!

g Evaluate the different aspects of migration from people, process and technology perspectives

g Understand the five essential components of migration g Discuss best practices for how to develop a sustainable migration plan

Sholeh Ehdaivand, President and CEO, LMK CLINICAL RESEARCH CONSULTING

11:45 PANEL: Ensure TMF Consistency Through the Harmonization of Procedures Across All Clinical Sites

g Introduce initiatives to encourage universal practices for the labeling and filing of documents

g Manage the different methods of ISF filing to keep it uniform across the trial TMF

g Institute healthy communication channels and training strategies to ensure clinical sites follow all procedures

Betsy Fallen, Global Head of Program and Business Development, SAFE-BIOPHARMA ASSOCIATIONAmy Lounsbury, Clinical Research Manager, MINNESOTA GASTROENTEROLOGY, P.A.

12:15 Networking Lunch

1:30 CASE STUDY: Effective Integration of TMFs for Acquired Products in a Dynamic Sponsor Environment

g Apply compliance-focused quality checks of the TMF g Harmonize TMF processes from legacy sponsors brought together by multiple mergers and acquisitions

g Establish uniform standards using the TMF Reference Model to create a foundation for continuous improvement

g Create and strengthen process alignment using a collaborative model that includes TMF functional contributors

Renee Fate, Associate Director, Global TMF Compliance, ALLERGAN

2:15 Discuss the Pros and Cons of Maintaining a Quality TMF by Using a

Centralized Versus Decentralized Model g Recognize that it takes a village to manage TMF quality g Analyze the differences between central and decentralized models g Explore the different models of centralization

Vinita Leslie, Director, Trial Master File Process Owner, Regulatory Operations, BIOGEN


3:30 Strategies for Mitigating Risk and Maintaining a Compliant eTMF System g Review common findings and mistakes to better prepare your team g Utilize audits and mock inspections to ensure you are maintaining a compliant TMF

g Create a risk-based approach that can assist in the formation of a standardized process for quality control review

Laura Naranjo, Manager, TMF Operations, DAIICHI SANKYO

4:00 PANEL DISCUSSION: The Impact of a CRO-Sponsor Relationship on a High Performing TMF Structure

g Study the impact of stakeholder oversight and metrics when a TMF is managed by a sponsor versus a CRO

g Identify the unique benefits of utilizing a CRO’s system g Recognize the impact of a strong CRO-Sponsor relationship on a defined eTMF strategy

g Benchmark effective strategies for proper outsourcing and the QCMelissa Maberry, Senior Director – Document Management, TMF Process Owner & Governance Team Leader, PRA HEALTH SCIENCESAnn Park, Clinical Compliance Officer, CPI GLOBAL CRODennis Boyle, Senior Analyst, Information Governance and Compliance, Global Quality and Compliance, PPDBen Rogers, Manager, Regulatory Records, INC RESEARCHMarion Mays, Director, Records Management, Records and Information Managment Operations - TMF Quality, QUINTILESIMS

4:45 Conclusion of Summit

Main Conference Day Two Thursday, January 19, 2017


THE #1 WORLDWIDE TMF SERIES

JANUARY 17-19, 2017 ORLANDO, FL

ASIA-PAC SEPTEMBER 27-28, 2017

TOKYO, JAPAN www.exlevents.com/tmfasia

EUROPEAN OCTOBER 16-17, 2017

LONDON, UK www.exlevents.com/eurotmf

6TH

“GOOD WAY TO ASK SOME TOUGH QUESTIONS. I THOUGHT THE FORMAT WAS VERY CREATIVE.”

—Senior CTA Clinical Systems, ALKERMES

6TH

www.exlevents.com/tmf

2ND


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REGISTRATION FEE: The fee includes the conference‚ all program materials‚ and designated continental breakfasts‚ lunches and refreshments.

PAYMENT: Make checks payable to ExL Events and write C837 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 offer 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.

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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.• Five days or less: A voucher (minus a $395 processing and documentation fee) to another

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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’s designated speakers and is designed for informational purposes for its attendees. It is NOT INTENDED for purposes of copywriting or 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 EXPRESSLY DISCLAIMS ALL WARRANTIES, EXPRESSED OR IMPLIED, AS TO THE ACCURACY OF ANY 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. ExL presentations may point to other websites that may be of interest to you, however ExL does not endorse or take responsibility for the content on such other sites.

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Ensure TMF Completeness Through SOP Creation, Data Management, Strong Partner Communication and Inspection Readiness

January 17-19, 2017 / Loews Royal Pacific Resort at Universal Orlando / Orlando, FL


6TH

Conference Code: C837

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