4th European Trial Master File Summit

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