£1,459.95 – £4,359.95

6th European Trial Master File Summit (EXL)

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London Marriott Hotel Regents Park

128 King Henry's Road

London

NW3 3ST

United Kingdom

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ExL Pharma’s European Trial Master File Summit continues to be the #1 source of information and replicable best practices in the life science industry. The quality and immediate relevance of topics are rivaled only by the caliber and zeal of our expert speaking faculty as well as the enthusiasm of participants at the event each year — and there is good reason for this.

This conference is by and for TMF professionals who play an active role in the identification and development of topics prior to the event. This event features a balance of:

  • select case studies vetted for relevance and scrutinized for poignancy
  • facilitated and informal peer-to-peer learning opportunities
  • broadly representative panels with complementary viewpoint
  • interactive sessions and workshops
  • industry leaders, preeminent experts, solution providers

At the summit, the interaction among this group of like-minded learners and leaders generates an unparalleled exchange of ideas and adaptation of strategies and tools. This October, 120+ participants, ranging from beginner to expert, will actively delve into principles, discuss pitfalls, discover strategies, and vet best practices suited to their TMF needs.

The 40+ speakers of 6th European TMF Summit are eager to confer the lessons they have learned on a wide yet cohesive range of topics tailored to your critical need for information, tools, savvy and professional development that will prepare you to return to work to

  • Improve TMF/eTMF quality through a defined structure and QC
  • Monitor the TMF/eTMF for completeness and compliance
  • Guarantee inspection-readiness through streamlined SOPs and sound governance
  • Effect and demonstrate the integrity of the trial data
  • Refine oversight of trials with proven metrics and tactical KPIs
  • Prepare for inspections with the benefit of regulatory and inspection trend updates

Top Five Reasons to Attend

  1. Enhance the quality of your TMF by creating and defining roles for stakeholders, implementing metrics, developing an inspection readiness platform, and improving governance of vendors
  2. Understand how to best prepare for inspections from all regulatory authorities
  3. Explore all the options when using a CRO’s or sponsor’s eTMF
  4. Ensure efficiency with an interoperability strategy
  5. Network with more than 150+ global TMF professionals

Testimonials

“[This is the] best European TMF conference where you can learn everything from CRO/sponsor issues, TMF QC techniques and eTMF/TMF readiness while being surrounded by more than 100 TMF professionals.”

“Great sessions on R&D budgets, Brexit and TMF compliance with regulations.”

“Great sessions on timely submissions, complete TMFs and inspection readiness.”

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 and eTMF Management
  • Clinical Document/Data Management
  • Clinical Trial Administration
  • Clinical Operations
  • Regulatory Affairs/Operations
  • Trial, Document and Record Management
  • Clinical Document Coordination
  • Clinical Development/Study Management
  • Quality Assurance/Control/Operations
  • Competency Development
  • Strategic Operations and Planning
  • Quality Management
  • Informatics
  • Clinical IT

This conference is also of interest to:

  • eTMF Service Providers
  • Data/Records Management Vendors
  • Clinical Research Organizations
  • Paper and Electronic Archiving Solution Providers

Agenda

Europe - Workshops | Monday, 16 October 2017
-8:00
Registration and Continental Breakfast
-9:00
WORKSHOP A
Review eTMF System Capabilities and Needs to Create a Clear Process and Efficient Ways to Utilise the System
An eTMF is no longer something that organisations consider to be an optional extra. It’s now recognised as an essential tool that can help with the basic functions of collecting, sorting and ensuring the quality of your documents to ensure that the trial is GCP compliant. Further, it can and should be a critical tool to facilitate study management. Whether you have a purpose-designed eTMF or a general document management system, you will need to have a process in place to utilise this technology strategically to improve your process and ensure alignment with your eTMF system. During this workshop, attendees will work their way through typical eTMF system functionality and align this with clinical trial processes to walk away with the understanding to:

Have full control and oversight of your eTMF system, so it becomes a user-friendly tool for study management
Understand enhancements and system updates
Create an efficient eTMF workflow process, aligned with the way that trial documents are used and created
Utilise your technology to apply quality control
Have strategic processes to collect and file documents

*This workshop includes a 30-minute networking break.
Eldin Rammell, Managing Director, RAMMELL CONSULTING
Jane Twitchen, Associate Director, Global Clinical Operations, BIOGEN

-12:00
Luncheon for Workshop A Attendees
-13:00
WORKSHOP B
Select and Implement an Out-of-the-Box eTMF System – An Interactive Workshop
Vetting eTMF systems can be a very large undertaking whether your company is large or small. The implementation project can be even larger and take extended time unless tight controls for scope and activity completion are adhered to by all. For the best chance of success, it is important to 1) use available tools/resources where they exist so as to not reinvent the wheel; 2) assign the right people to the project; and 3) garner heavy investment from senior management to ensure prioritisation in the project team members’ work schedules. This workshop will utilise a very recent, very successful case study of a small biotech company to review, step by step, through the eTMF system selection process and 21-day implementation project. Goals of the workshop attendees are:

Create the scope of the project, beginning with the development of the questions to understand the goals of the project from start to finish
Use the proper tool for the creation of the RFP for facilitating vendor vetting and selection
See the request for project approval and funding through the eyes of senior management
Review the critical-to-success roles on the eTMF implementation team
Evaluate the project plan template determine and preempt possible delay and pitfalls

*This workshop includes a 30-minute networking break.
Neil Bell, Head of Clinical Operations, AUTOLUS
Lisa Mulcahy, TMF Management Consultant, MULCAHY CONSULTING

16:00
Workshop Day Concludes

Europe - Day One | Tuesday, 17 October 2017
-8:00
Registration and Continental Breakfast
-8:45
Co-Chairs’ Opening Remarks
Karen Roy, Senior Vice President, Client Solutions, PHLEXGLOBAL
Vittoria Sparacio, Head, Clinical Documentation Operations, GLAXOSMITHKLINE
-9:00
Analyse on GCP Compliance in Relation to Trial Master File for Content, Management, Archiving, Audit and Inspection of Clinical Trials

Maintain an inspection-ready TMF that achieves GCP compliance and demonstrates the integrity of the trial data
Mitigate risks to compliance of EMA’s guidelines on GCP
Refine your document management process to mitigate impact of TMF structure and content

-9:45
Consider Best Practices to Prevent Critical Findings

Hear a regulatory update on inspection trends and their impact on TMF management
Anticipate and prepare for the effects of data integrity requirements and for ICH E6 on TMF documentation
Integrate the new terminology for GCP records management
Maintain an inspection-ready TMF that demonstrates the integrity of the trial data

Karen Roy, Senior Vice President, Client Solutions, PHLEXGLOBAL
-10:30
Networking Break
-11:00
Ensure Data Integrity for GxP Impact on an Accurate and Complete Trial Master File

Survey MHRA’s guidance will affect long-term retention of audit trials and electronic signatures
Minimise integrity issues by creating a plan with a table of contents
Receive an introduction to dynamic data
Compare and contrast ramifications of paper, electronic and hybrid TMF models on the viewing of documents

-11:45
Panel Session: Utilise an eTMF to Monitor All Aspects of the TMF, Vendors, Quality and Clinical Research Sites

Understand how to utilise your eTMF to monitor and enhance vendor governance
Recognise the changes underway in clinical quality oversight operations in light of the changing regulatory environment
Identify the benefits of a conceptual framework for a proactive approach for end-to-end management of issues generated through clinical research activities
Implement KPIs and metrics to monitor outsourced functions in order to have better oversight of the trial
Harness the impact of an eTMF system to increase quality

Jeannette Dixon, Associate Director, Clinical Operations Quality Oversight, BIOGEN
Jeff Pilot, Senior Clinical Project Manager, NORGINE
-12:45
Networking Luncheon
-13:45
Case Study Develop and Rollout a TMF Management Plan With CRO for Sandoz Biosimilar Clinical Development

Understand the need for an integrated plan to ensure your CRO performs TMF filing according to agreed standards
Explore the topics that need to be included in the TMF management plan and their correlation to EMA’s recommendations
Discuss the following experiences that relate to defining content of TMF management plans:
Creating a mapping structure for a table of contents
Agreeing on formats for sponsor quality check reports
Transferring complete eTMF files to sponsor after study closeout

Claudia Panitz, Head Regulatory Readiness and Archival/ GDO, NOVARTIS
-14:30
Ensure a High Quality TMF Through Positive CRO/Sponsor Interactions and Oversight

Maintain CRO/sponsor oversight plans that directly outline roles and responsibilities for all documentation processes
Identify challenges in the work stream across sponsors, CROs and investigator sites
Utilise an eTMF application to drive trial efficiency, improve collaboration and help organisations gauge performance with shared metrics
Adopt best practices to create and maintain a compliant and high-quality workflow

Jamie Toth, Head of TMF Operations, DAIICHI SANKYO
-15:15
Networking Break
-15:45
Presentation by Veeva Systems
Franciska Darmer, Director, Veeva Vault eTMF Strategy, VEEVA SYSTEMS
-16:30
Address TMF Strategy Considerations for Essential Safety Documents to be Compliant with Article 57

Survey safety trial documents necessary to allow verification of the trial conduct and data quality
Incorporate of safety requirements in your TMF plan, index and filing strategy, and sponsor oversight
Overcome barriers to file safety documentation in eTMF
Discuss examples of how to manage during inspections and audits

Lucy Hampshire, Director, Medicines Quality Organisation - Europe, ELI LILLY
Jennifer Maier, Associate Director, R&D Quality Compliance, ALEXION PHARMACEUTICALS
-17:15
Day One Concludes

Europe - Day Two | Wednesday, 18 October 2017
-8:30
Registration Opens and Continental Breakfast
-9:00
Co-Chairs’ Recap of Day 1
Karen Roy, Senior Vice President, Client Solutions, PHLEXGLOBAL
Vittoria Sparacio, Head, Clinical Documentation Operations, GLAXOSMITHKLINE
-9:15
Oversee an eTMF for a CRO-Run Study With Proven Processes and Tools

Perform due diligence on a vendor eTMF by identifying and prioritising what you are looking for
Clarify sponsor needs and expectations for access to a CRO’s eTMF
Survey the types of evidence sponsors should be prepared to provide
Vet electronic tools for supporting due diligence
Discuss actions that should be taken at closeout

Kathie Clark, Vice President, Product Management, WINGSPAN TECHNOLOGY, A QUINTILESIMS COMPANY
Martin Hausten, Team Lead Global Document Specialist, Head of Global Document Quality Content, BOEHRINGER INGELHEIM
-10:00
Case Study Utilise an eTMF to Assist in Monitoring Metrics and Ensuring Data Quality

Have the cleanest data possible and the automation process behind this function
Work with sites to ensure ground-level documents are complete before put into the system
Implement KPIs from a trial level
Look at per-trial and function dashboards
Design and execute a top-down and bottom-up approach to monitoring

Timothy Rafferty, eTMF Quality and Metrics Manager, ROCHE
-10:45
Networking Break
-11:15
Case Study Apply a Risk-Based Approach to Your TMF

Enhance your QC process and your approach to document management
Utilise risk to ensure a TMF is of the best quality when originally put in the TMF
Identify facets of the TMF that have the highest probability for quality issues
Manage the impact of implementing an eTMF under strict budget constraints

Ruth Coll, Senior Clinical Program Manager, TRIZELL
-12:00
Assure TMF Quality Through the Engagement of People and Establishment of Processes and Systems

Examine the direct correlation of proper TMF quality management procedures for improved decision making and inspection readiness
Analyse TMF data to assess the current quality of your TMF and identify weaknesses
Leverage analysis conclusions and patterns to inform improvements to your document management system and tools
Harness metadata and a defined folder structure to engender an up-to-date TMF
Identify areas of focus for further training and professional development via TMF quality management

Dorte Frejwald Christiansen, TMF Lead, Principal Consultant, NNIT
-12:45
Networking Luncheon
-13:45
Case Study Define, Monitor and Remain Inspection-Ready

Define what inspection-ready means to the organisation and the trial
Understand internal stakeholders who contribute to the TMF to ensure they are adding compliant documents
Ensure that your definition of a complete TMF is consistently conveyed throughout your organisation
Vet strategies to remain inspection-ready

Emma Webby-Mears, Senior Clinical Document Manager, VECTURA GROUP
-14:30
Case Study Document and Content Management Part of a Robust Quality Management System

Implement document and content management as integral components of a quality management system
Get an overview of methods for evaluating processes and operations
Demonstrate the process by which a pathway to improvement is delivered

Scott McCulloch, Associate Director, Development Sciences Quality, BIOMARIN EUROPE
-15:15
Networking Break
-15:45
Understand the Impact and Showcase the Process of Documentation Within the TMF

Look at the TMF as a deliverable and not as a document structure
Comprehend the process of the TMF and the larger picture of inspection preparation
Include ICH GCP R2 regulations into the oversight of documents from vendors
Modify a TMF structure so that an inspection can find documents and all corresponding documentation appropriately

Nancy Meyerson–Hess, Associate Partner; Former Head of Clinical Operations and Compliance, ADMEDICUM BUSINESS FOR PATIENTS; GRUNENTHAL
-16:30
Ensure TMF Completeness

Harness and manage unstructured and structured content
Leverage milestones and dashboards to encourage and oversee completeness
Communicate definitions of and expectations for completeness to internal allies and external partners
Compare the facets and functionality of electronic tools for their suitability for disparate study nature and design
Ensure completeness of documents prior to being put into the system

-17:15
Conference Concludes


SPEAKERS


Neil Bell
Head of Clinical Operations

AUTOLUS
Dorte Frejwald Christiansen
TMF Lead, Principal Consultant

NNIT
Kathie Clark
Vice President, Product Management

WINGSPAN TECHNOLOGY, A QUINTILESIMS COMPANY
Ruth Coll
Senior Clinical Program Manager

TRIZELL
Franciska Darmer
Director, Veeva Vault eTMF Strategy

VEEVA SYSTEMS
Jeannette Dixon
Associate Director, Clinical Operations Quality Oversight

BIOGEN
Lucy Hampshire
Director, Medicines Quality Organisation - Europe

ELI LILLY
Martin Hausten
Team Lead Global Document Specialist, Head of Global Document Quality Content

BOEHRINGER INGELHEIM
Jennifer Maier
Associate Director, R&D Quality Compliance

ALEXION PHARMACEUTICALS
Scott McCulloch
Associate Director, Development Sciences Quality

BIOMARIN EUROPE
Nancy Meyerson–Hess
Associate Partner; Former Head of Clinical Operations and Compliance

ADMEDICUM BUSINESS FOR PATIENTS; GRUNENTHAL
Lisa Mulcahy
TMF Management Consultant

MULCAHY CONSULTING
Claudia Panitz
Head Regulatory Readiness and Archival/ GDO

NOVARTIS
Jeff Pilot
Senior Clinical Project Manager

NORGINE
Timothy Rafferty
eTMF Quality and Metrics Manager

ROCHE
Eldin Rammell
Managing Director

RAMMELL CONSULTING
Karen Roy
Senior Vice President, Client Solutions

PHLEXGLOBAL
Vittoria Sparacio
Head, Clinical Documentation Operations

GLAXOSMITHKLINE
Jamie Toth
Head of TMF Operations

DAIICHI SANKYO
Jane Twitchen
Associate Director, Global Clinical Operations

BIOGEN
Emma Webby-Mears
Senior Clinical Document Manager

VECTURA GROUP



Sponsors


NNIT


NNIT

NNIT is an international consultancy in the development, implementation, validation and operation of IT for the life sciences industry.

We create value for our clients by treating their IT as if it were our own and, of course, we meet the industry’s strictest requirements for quality.

We apply the latest advances in technology to make our clients’ software, business processes and communication more effective.


Phlexglobal

Phlexglobal

Phlexglobal are the Trial Master File (TMF) experts, and pioneers in the provision of innovative, flexible and technology-enabled TMF solutions and services.

A specialist provider of electronic Trial Master File (eTMF) solutions and other support services to the global clinical research market, we offer a unique combination of technology, quality and services that deliver a range of flexible, targeted solutions to the life science industry.


TransPerfect

TransPerfect

TransPerfect provides a collaborative web-based platform for study start-up and eTMF that enables sponsors, CROs, IRBs, central laboratories and other vendors to maintain and update clinical trial documentation in a secure online environment. TransPerfect's Life Sciences division is dedicated to working with clients on a global, collaborative level, supporting a wide range of requirements including product licensing and alliance management, endpoint adjudication, eTMF review/reconciliation, and pharmacovigilance.


Wingspan Technology, Inc.

Wingspan Technology, Inc.

Wingspan Technology, a QuintilesIMS company, provides an ECM platform for the life sciences industry in a high-performance, scalable, validated cloud environment. Our industry-leading eTMF is used by sponsors and CROs of all sizes to manage trials from planning through archival. Wingspan eTMF provides the transparency needed to understand TMF health and inspection readiness, along with tools to support and measure the productivity of eTMF processes. As a result, eTMF contributed significantly to supporting our clients’ record of successful health authority inspections.



Event Partners


MEDtube.net

MEDtube.net

MEDtube is an innovative video education platform for health professionals. It allows sharing videos and other materials with a community of more than 110,000 users worldwide, as well as building e-learning courses. The videoteque is updated daily and now contains almost 15 thousand videos.

Pharmaphorum

Pharmaphorum

Pharmaphorum is the exciting new online discussion and networking site for the pharma, medical devices and diagnostics industry. It features topical articles by industry thought leaders upon which users can comment, a live forum for open discussion across various commercial and R&D areas, and a directory of conferences and companies. Aimed at those working in the industry or associated services sector, pharmaphorum welcomes all those involved in bringing healthcare to market who wish to share opinions and ideas in order to drive innovation and progression. Visit pharmaphorum today to share, discuss and debate.

PharmaVoice

PharmaVoice

PharmaVOICE magazine reaches more than 41,000 qualified subscribers and 100,000 users with its digital edition. PharmaVOICE is the forum that allows business leaders to engage in a candid dialogue on the challenges and trends impacting the industry. PharmaVOICE provides readers with insightful and thought-provoking commentary in a multiple-perspective format through forums, topics and articles covering a range of issues from molecule through market. PharmaVOICE subscribers are also kept abreast of the latest trends and information through additional media resources, including Social Media, WebLinx Interactive WebSeminars, Podcasts, Videocasts, White Papers, E-Surveys and e-Alerts.


PM360

PM360

PM360 is the premier, must-read magazine for marketing decision-makers in the pharmaceutical, biotech and medical device industries. Published monthly, PM360 is the only journal that focuses on delivering the full spectrum of practical information necessary for product managers and pharma marketing professionals to succeed in the complex and highly regulated healthcare environment. The journal's targeted and insightful editorial focuses on issues that directly impact critical decision-making, including the planning and implementation of cutting-edge strategies, trends, the latest technological advances, branding/marketing, advertising/promotion, patient/professional education, sales, market research, PR and leadership. Additionally, the "360" in our title signifies the combination of this critical, how-to info with personal and career insights for an enjoyable and thought-provoking read. By providing the full circle of enriching content, PM360 is truly an indispensable tool for busy and productive marketing professionals to stay at the top of their game.

Technology Networks

Technology Networks

Technology Networks is an internationally recognised publisher that provides access to the latest scientific news, products, research, videos and posters. Our global community is made up of over 300,000 researchers and scientific professionals from the life science, drug discover and analytical arenas.


Please contact the event manager Marilyn below for the following:
- Discounts for registering 5 or more participants.
- If you company requires a price quotation.
Event Manager Contact: marilyn.b.turner(at)nyeventslist.com
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.

NO REFUNDS OR TRANSFER ALLOWED ON REGISTRATIONS
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Date and Time

Location

London Marriott Hotel Regents Park

128 King Henry's Road

London

NW3 3ST

United Kingdom

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