TRIAL MASTER FILE TMF EUROPEAN SUMMIT OCTOBER, 2014 HILTON LONDON KENSINGTON

Transcription

1 3RD ANNUAL THE ONLY CONFERENCE IN EUROPE COMPLETELY DEDICATED TO TRIAL MASTER FILES! EUROPEAN TRIAL MASTER FILE SUMMIT Maintaining a Compliant Electronic and Paper TMF for Audits and Inspections OCTOBER, 2014 HILTON LONDON KENSINGTON VINITA LESLIE MARTIN THORLEY KAREN (REDDING) ROY KIM SONGCO Director, Trial Master File Process Owner, Regulatory Operations BIOGEN IDEC TMF Content Integration Lead PFIZER Global Business Development Director, PHLEXGlobal Country etmf Coordinator ASTRAZENECA CRO OVERSIGHT & MANAGEMENT EMA, FDA, PMDA, & MHRA REGULATIONS etmf TRAINING AND ROLLOUT TMF TOP REASONS TO ATTEND Develop a clear understanding of MHRA, EMA, and FDA guidelines for TMF Explore best practices for implementing monitoring and archiving your TMF electronically Gain insight on electronic industry trends for electronic signature and archiving TMF Uncover a better strategy of etmf integration between a sponsor and CRO Develop a compliant TMF process for filing documents in paper and electronic platforms SPONSORED BY This Year s Summit Features: Updates on the latest MHRA & EMA regulations Case studies on how to strengthen communication between sponsor companies and CROs Best practices for maintaining a compliant and complete TMF at all times Interactive panel discussion on a global TMF platform W ingspan Technology, Inc.

2 DEAR COLLEAGUE, Maintaining a complete, updated and easily accessible trial master file is not a simple task. Juggling clinical trials at multiple sites across the globe in a landscape of shifting regulations is a momentous task. TMF professionals need to be masters of organization and communication to keep track of, file, archive and warehouse signed protocols, audit certificates, patient enrollment logs, and thousands of other documents that demonstrate the safe conduct of the clinical trial, patient management, and the integrity and compliance of the trial with Good Clinical Practice Over the last few years technology has evolved there has been a shift to electronic TMFs which have brought a new set of concerns, challenges and most importantly costs. Making the decision to move to an etmf or how to best roll out a system is a top-of-mind challenge for any organization. Professionals are looking for regulatory guidance as thought leaders are formulating industry-wide standards to provide clarity and direction through the DIA Reference Model and OSHA Standards. As the only conference in Europe dedicated to addressing the concerns of TMF professionals we will continue to bring you premiere TMF thought leaders that will help you understand the new regulations, complex MHRA guidances, industry standards and new technologies. Join us this October and network with your peers from all over the globe to discuss challenges, best practices and proven benchmarks to increase efficiency and maintain compliance for paper and electronic TMF. NEW FEATURED CASE STUDIES AND INTERACTIVE SESSIONS FOR 2014: Essential Documents to Ensure a Complete TMF Under all Regulations Case Study conducting a PDMA TMF Inspection in the UK Best Practices for Effective Oversight and Management of CROs Build an Effective TMF Process that is utilized for multiple trials, globally and provides reporting standards Implement a Secure and Efficient etmf System I look forward to meeting you in London this October! Sincerely, Natasia Langfelder Natasia Langfelder Conference Production Director, Trial Master File Series nlangfelder@exlpharma.com Scott Grossman Team Lead, Production The BUZZ on Exl s Trial Master File Series-What Your Peers are Saying: THE EXPERIENCES SHARED WITH US FROM THE TMF LEADERS IS SOMETHING I WILL DISCUSS FURTHER IN MY OWN DEPARTMENT Clinical Trial Director, Novo Nordisk VALUABLE CONTENT, WELL PRESENTED Quality Assurance, Pfizer GOOD BALANCE OF EXPERIENCES AND SOLUTIONS FOR TMF FILING/ARCHIVING Director, Development Orion Who Should Attend: This conference is designed for representatives from pharmaceutical, biotech, medical device and clinical research companies with responsibilities in the following areas: TMF & etmf Professionals Clinical Operations Document/Data Management Regulatory Affairs Clinical Document Coordinator Clinical Development Regulatory Operations Regulatory Affairs Essential Document Management Quality Assurance and Operations Strategic Operations and Planning Data Management Clinical Trial Managers Quality Management Informatics Clinical IT Document & Record Specialist This conference is also of interest to Document and TMF Service Providers etmf Software Providers Electronic Signature Providers Data Storage Service Providers Document Management Organizations 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 INTERESTED IN SPONSORSHIP & EXHIBITION OPPORTUNITIES? Do you want to spread the word about your organization s solutions and services to potential clients who attend this event? Take advantage of the opportunity to exhibit, present an educational session, host a networking event, or distribute promotional items to attendees. 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

3 MONDAY OCTOBER 20, 2014 WORKSHOP 8.00 Registration Opens & Continental Breakfast for Workshop Participants 9.00 WORKSHOP: LEVERAGE PLATFORMS TO BUILD AN EFFECTIVE TMF PROCESS Industry professionals are constantly working to create a way to standardize the TMF processing including the DIA TMF reference model or OASIS to build a TMF across the industry. This interactive workshop is designed to help you get acquainted with the ins & outs of the model as well as how to use it both in a paper and an etmf setting. This interactive session addresses: xxeffective Trial Management Techniques xxcentral Trial Document Protocol xxregulations regarding communications, tracking, trial status reporting and more Eldin Rammell, Consultant, RAMMELL CONSULTING This workshop has a 30 minute networking break MAIN CONFERENCE DAY ONE Lunch for Workshop Attendees & Main Conference Registration CO-CHAIR S WELCOME & OPENING REMARKS KEYNOTE: CASE STUDY: PDMA TMF INSPECTION IN THE UK xxpreparation for a PDMA inspection and how it differs from EMA/FDA preparation xxlearn what the inspectors expect and what they are looking for xxlessons learned and how to prepare for future inspections Vinita Leslie, Director, Trial Master File Process Owner, Regulatory Operations, BIOGEN IDEC SOLVING THE COMPLEXITIES OF THE SPONSOR CRO TRIAL MASTER FILE MANAGEMENT RELATIONSHIP TO MAINTAIN INSPECTION READINESS xxunderstand the current outsourcing market and the TMF management practices xxidentify critical areas to ensure completeness and accuracy of the TMF xxunderstand how to facilitate smooth transfer of documents between sites and sponsor companies xxunderstand the challenges surrounding document ownership in order to better the solutions xxexplore the benefits of employing an etmf platform to increase the sponsor/cro partnerships oversight Networking Break & Afternoon Refreshments CASE STUDY: OVERCOMING THE CHALLENGES FACED DURING AN etmf ROLLOUT xximportant factors to consider when choosing an etmf xxsuccessful IT integration of an etmf xxetmf training for sites and sponsors xxaddress the impact of clinical efficiencies through an etmf system Andrew Mitchel, Solutions Architect, Life Sciences, INTRALINKS PANEL DISCUSSION: SIGNATURE PRACTICES AND TECHNOLOGIES FOR TMF: AN INDUSTRY OVERVIEW xxexplore the new technologies in the market xxcase studies of how these technologies have been applied successfully xxmetrics to benchmark the usefulness of these technologies xxensure compliant standards are in place for review and release of the TMF structure, TMF preparation and TMF maintenance xxtraining and educating staff on new technologies Kathie Clarke, etmf Product Manager, WINGSPAN TECHNOLOGY INC Conclusion of Day One I COME TO THIS EVENT EVERY YEAR, I CONSIDER IT A TOP PRIORITY Clinical Trial Manager, Amgen

4 TUESDAY OCTOBER 21, Registration Opens & Continental Breakfast 9.00 CO-CHAIR S WELCOME & OPENING REMARKS 9.15 TMF QUALITY CONTROL: CONTROLLING AND MANAGING TMF QUALITY TO BE PREPARED FOR INSPECTIONS FROM THE START xxexamining what kinds of metric and control measures can be implemented xxanalyzing, anticipating, and managing risk (e.g. inspection risk, launch risk) xxcontrolling the TMF is part of your process, not a separate, retrospective activity Martin Hausten, Project Compliance Manager, BOEHRINGER INGELHEIM IMPLEMENT A SECURE AND EFFICIENT etmf SYSTEM xxmaintain an up-to-date and easily accessible TMF through upgrading your paper TMF to an etmf xxshare documents between sites quickly and efficiently in case of an inspection xxensure safety of confidential data by submitting it through a secure network xxbest practices for interoperability and complete IT integration Martin Thorley, Senior Manager, PFIZER Networking and Refreshment Break ESSENTIAL DOCUMENTS TO ENSURE A COMPLETE TMF UNDER ALL REGULATIONS xxoverview of a clear definition of what constitutes a complete TMF xxsift through essential documents and set an internal standard of crucial documents to have ready for inspections xxdiscuss international regulations and ensure that your internal standard could withstand inspection from any regulatory body Amer Alghabban, Director Global R&D and GVP Quality Assurance, ABBOTT DIABETES CARE UTILIZE AN INTEGRATED CLOUD BASED CLINICAL TRIAL PORTAL AND etmf TO REDUCE CYCLE TIMES xxdate development of your etmf into your eclinical system from a EDC need perspective xxlearn how to speed trial set-up, document retrieval and improve communications through cloud storage xxensure security for your more sensitive data whilst increasing storage capacity Networking Break & Afternoon Refreshments HOW TO ACHIEVE CONTINUOUS IMPROVEMENT THROUGH SITE MONITORING xxexplore TMF from the site monitor s perspective xxset-up and run a pre-audit review of Trial Master File to ensure a state of continuous compliance xxfile management and re-development of filing hierarchy xxbest practices for setup and maintenance of Trial Master Files (TMF), Investigator Site Files (ISF) and Case Report Form files Deborah Wyndham, Clinical Trial Manager, ROCHE PANEL DISCUSSION: GLOBAL TMF- PREPARING FOR INSPECTIONS IN COUNTRIES AROUND THE WORLD xxfeatures an international slate of panelists sharing their experiences going through TMF inspections xxlearn what the inspection process is like in different countries and how to best remain compliant xxhear the best methods to ensure that your documents can be quickly and easily accessed for inspectors Amer Alghabban, Director Global R&D and GVP Quality Assurance, ABBOTT DIABETES CARE Conference Conclusion Luncheon BEST PRACTICES FOR EFFECTIVE OVERSIGHT AND MANAGEMENT OF CROS xxstrategies to ensure that your CRO is GCP compliant xxprovide sufficient training on new technologies to avoid receiving a warning letter during inspection xxemploy a system to ensure reliable correction of any identified problems or issues Isabelle Naëije, Project Manager, ACTELION WHAT GREAT PRESENTATIONS! I HEARD FROM A WIDE VARIETY OF EXPERTS. Sr. Data Manger, Pfizer IT S ALWAYS IMPORTANT TO STAY ON TOP OF THE LATEST REGULATIONS. THIS IS A TIME- SENSITIVE INDUSTRY WITH A LOT AT STAKE Clinical Trial Manager, Amgen ON THE WHOLE A VERY OPEN & FRIENDLY EXCHANGE OF QUESTIONS AND EXPERIENCES, VERY INFORMATIVE. Clinical Ops Trial Support, Bayer Pharma AG

5 Ways to Register: To Register Contact: Jonathan Banchs REGISTRATION FEES EARLY BIRD PRICING Register by September 12, 2014 Conference & Workshop: 1395 Conference Only: 1295 VENUE: Hilton London Kensington Holland Park Ave London W11 4UL UK Hotel booking info: To make reservations please call and provide the group code GEXLC to receive the negotiated rate. You may also use the following weblink to make reservations online: com/en/hi/groups/personalized/l/lhrhitw-gexlc /index.jhtml The group rate is available until September 26, Please book your room early as rooms available at this rate are limited. Media Partners STANDARD PRICING Register after September 12, 2014 Conference & Workshop: 1595 Conference Only: 1395 ONSITE PRICING Conference & Workshop: 1795 Conference Only: 1595 Includes Sales Taxes and Service Fees 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. Questions? Comments? Do you have a question or comments that you would like to be addressed at this event? Would you like to get involved as a speaker or discussion leader? Please Program Director, Natasia Langfelder at nlangfelder@exlpharma.com 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: Make checks payable to ExL Events, Inc. and write code C519 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. 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. Group discounts available to individuals must be registered simultaneously and employed by the same organization. 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. 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

6 Ways to Register: To Register Contact: Jonathan Banchs Method of Payment: Check Credit Card Make checks payable to ExL Events, Inc. Card Type: MasterCard Visa Discover AMEX Card Number: Exp. Date: Name on Card: Yes! Register me for the Conference + Workshop Yes! Register me for the Conference Please contact me: I wish to receive updates on ExL Pharma's upcoming events Signature: Conference Code: C519 Name: Title: Company: Dept: Address: City: State: Zip: Phone: Fax: 3RD ANNUAL WHAT GREAT PRESENTATIONS! I HEARD FROM A WIDE VARIETY OF EXPERTS. Sr. Data Manger, Pfizer EUROPEAN TRIAL MASTER FILE SUMMIT Maintaining a Compliant Electronic and Paper TMF for Audits and Inspections OCTOBER, 2014 HILTON LONDON KENSINGTON CRO OVERSIGHT & MANAGEMENT EMA, FDA, PMDA, & MHRA REGULATIONS etmf TRAINING AND ROLLOUT TMF