£1,440 – £4,340

6th European Trial Master File Summit (EXL)

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Description

From SOP creation to a study’s start-up and archival, the trial master file (TMF) plays an important role in a clinical trial. It should come as no surprise, then, that TMF professionals face a number of challenges in relation to creating an oversight plan, ensuring quality and implementing metrics.

Many organizations are still creating TMF standard operating procedures to guarantee the quality and accuracy of the TMF. During clinical trials, project teams are responsible for numerous tasks — and filing clinical materials into the TMF may not always be their top priority. Additionally, they may not formally turn their attention to TMF quality control until well after study closeout, which makes it more difficult to resolve any documentation gaps they identify. This process also becomes more challenging when you add in CROs and a number of clinical research sites.

Now in its sixth year, ExL Pharma’s European Trial Master File Summit — convening 16-18 October 2017 in London, UK — will continue to provide an educational platform for professionals to explore best practices to ensure TMF completeness and inspection readiness through streamlined document management and a defined SOP, metrics and a governance structure.

At the 7th Trial Master File Summit, 40+ speakers will share best practices on a wide range of topics including:

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

Topics under consideration for this year’s event include:

  • How to ensure quality from a site level before documents are incorporated into the TMF
  • The impact of rolling out or implementing a new eTMF
  • Ways to guarantee TMF quality
  • Methods for implementing a second-generation TMF
  • The role change management plays in TMF metrics and dashboards
  • CRO oversight, governance issues and challenges
  • Best practices for creating a TMF/eTMF strategy
  • TMF QC/readiness checks
  • How to destroy files through proper channels while complying with regulations
  • Best practices for managing access and record presentation
  • Ways to prepare for physical and remote inspections
  • Retention of the TMF
  • Data integrity when data is maintained in an eTMF
  • How to respond to MHRA findings from the records group perspective


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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