4th European Trial Master File Summit

Start

Mon, 12 Oct 2015, 08:00

End

Tue, 13 Oct 2015, 06:00

WebSite

Venue:

A Trial Master File (TMF) is a collection of hundreds of thousands of pages of clinical documents compiled to prove that good clinical practice (GCP) is being met. Because of the importance of a TMF, organizations must understand how to efficiently develop, manage and create a TMF process that ensures high quality, inspection readiness and operational efficiency. In order to accomplish this, professionals involved in the TMF must first create a structure for collection, monitoring and performing quality checks regardless of whether the trial is conducted.

KEYNOTE SPEAKERS

Amer Alghabban

******@***gmail.com

Vice President - Gxp Quality Assurance, Compliance Training

Exhibit

Symposia

Workshops

Organiser

Sponsor

General Info

Now in its fourth year, ExL Pharma’s European Trial Master File Summit — convening on 12-13 October 2015 in London, UK — will continue to provide an educational platform for professionals to explore best practices to enhance their eTMF or paper TMF platform in order to increase quality and ensure inspection readiness.

Top Reasons to Attend:

A keynote presentation from the MHRA’s senior GCP inspector, Andy Fisher, who will be discussing an inspector’s expectation of TMF accessibility and availability
A interactive pre-conference workshop on how to develop and enhance your TMF process and structure to meet business, technology and regulatory needs
6+ case study presentations from representatives of Actelion, Polyphor, Boehringer Ingelheim, Leo, Phlexglobal and other organizations
Engaging panel sessions on enhancing the collection of eISF and managing internal and external email correspondence
9+ hours of networking with the largest community of TMF professionals
14+ hours of educational sessions that will provide you with best practices, lessons learned and case studies

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 program will also be of interest to:

eTMF Service Providers
Data/Records Management Vendors

Clinical Research Organizations
Paper and Electronic Archiving Solution Providers

Registration Process

STANDARD RATE
	Price
Conference & Workshop	£1,595
Conference Only	£1,395

ONSITE RATE
	Price
Conference & Workshop	£1,795
Conference Only	£1,595

*Includes Sales Tax 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 four). A savings of 25% per person.

SAVE 15%
Can only send three? You can still save 15% off of every registration. To find out more on how you can take advantage of these group discounts, please call 212-400-6240.

REGISTRATION FEE:

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

Programme Overview

Pre-Conference Workshop


DAY ONE — 12 OCTOBER 2015

8:00 – 8:45	Registration Opens and Continental Breakfast for Workshop Participants
8:45 – 11:45	PRE-CONFERENCE WORKSHOP: Develop and Enhance Your TMF Process and Structure to Meet Business, Technology and Regulatory Needs
	Martin Thorley, Senior Information Manager, PFIZER
	Eldin Rammell, Consultant, RAMMELL CONSULTING
11:45 – 12:45	Luncheon for Workshop Attendees and Main Conference Registration



DAY ONE — 12 OCTOBER 2015


11:45 – 12:45	Main Conference Registration
12:45 – 13:00	Co-Chairs’ Welcome and Opening Remarks
	Karen Roy, Senior Vice President, Client Solutions, PHLEXGLOBAL
	Vittoria Sparacio, Head, Document Management and Archiving, GLAXOSMITHKLINE
13:00 – 13:45	KEYNOTE: Inspector Expectation of TMF Accessibility and Availability
	Andy Fisher, Senior GCP Inspector, MHRA
13:45 – 14:30	CASE STUDY: Develop a Plan and Implement TMF Governance
	Martin Hausten, Project Compliance Manager, BOEHRINGER INGELHEIM
	Benedicte Querton, Group Leader - Regional Documentation Management, BOEHRINGER INGELHEIM
14:30 – 15:00	CASE STUDY: Map Your Organization’s TMF While Keeping Standardization, Flexibility and Interoperability in Mind
	Karen Roy, Senior Vice President, Client Solutions, PHLEXGLOBAL
15:00 – 15:30	Networking Break
15:30 – 16:00	Ensure Interoperability While Utilizing a CRO’s or Sponsor’s eTMF
	Lorrie Dixon, Trial Master File Manager, F. HOFFMANN-LA ROCHE
16:00 – 16:30	CASE STUDY: Utilize the DIA Reference Model as the Foundation to Improve the TMF Process
	Signe Juul, Senior Clinical Process Manager, LEO PHARMA
16:30 – 17:00	Moving Along the TMF Maturity Continuum
	Rik van Mol, Vice President, R&D Strategy, Europe, VEEVA SYSTEMS
17:00 – 18:30	TMF, Crudité and Drinks Roundtable
18:30 – 18:30	Conclusion of Day One


Main Conference Day 2

DAY TWO — 13 OCTOBER 2015


8:00 – 9:00	Registration Opens and Continental Breakfast
9:00 – 9:15	Co-Chairs' Welcome and Opening Remarks
	Karen Roy, Chief Business Development Officer, PHLEXGLOBAL
	Vittoria Sparacio, Global Head, Document Management and Archiving, GLAXOSMITHKLINE
9:15 – 10:15	PANEL SESSION: Managing Both Internal and External Email Correspondence Within the Trial Master File
	Kathie Clark, eTMF Product Manager, WINGSPAN TECHNOLOGY INC.
	Sameera Thanathparambil, Senior Specialist, Quality Assurance, JANSSEN
	Angela Salden, Associate Director, Global Study Standards, Processes & Tools, ASTRAZENECA
	Emma Webby, Senior Clinical Document Manager, VECTURA
10:15 – 10:45	eTMF: A Case Study Look at Why? When? And How?
	Garrett D. Smith, Executive Director, TRANSPERFECT LIFE SCIENCES SOLUTIONS
10:45 – 11:15	Networking and Refreshment Break
11:15 – 12:00	Prepare Your TMF Activity from the Start of Your Trial in Order to Have an Inspection-Ready TMF at the End
	Linda James, Senior Specialist, GCO Document Quality, Process and Operations Quality Operational Capabilities, BIOGEN
12:00 – 13:00	Luncheon
13:00 – 13:45	CASE STUDY: TMF Quality and Inspection Readiness Through a Defined Monitoring Process
	Amer Alghabban, Vice President GxP Quality Assurance, Compliance and Training, KARYOPHARM THERAPEUTICS
13:45 – 14:30	Case Study: Implementing an eTMF Highlights and Lessons Learned After Two Years
	Simone Mechler, Associate Director, eClinical Projects, Clinical Development Informatics, ACTELION
14:30 – 15:00	Networking Break
15:00 – 16:00	PANEL SESSION: Enhance the Collection and Management of Electronic Investigator Site Files (eISF) Documents
	Sameera Thanathparambil, Senior Specialist, Quality Assurance, JANSSEN
	Jane Twitchen , Associate Director of Records Systems and Operations, BIOGEN
	Adam Kelch, Product Manager, EMC DOCUMENTUM FOR LIFE SCIENCES CLINICAL SOLUTIONS
16:00 – 16:15	Co-Chairs’ Closing Remarks
16:15 – 16:15	Conference Concludes