4th European Trial Master File Summit
Start:
Mon, 12 Oct 2015, 08:00
End:
Tue, 13 Oct 2015, 06:00
Website:
Venue:
Nr Covent Garden, London WC1B 3QD
United Kingdom
KEYNOTE SPEAKERS
Exhibit
Symposia
Workshops
Organiser
Sponsor
General Info
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:
|
|
This program will also be of interest to:
|
|
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 |
More events
Wed, 16 Oct 2024 - Sat, 19 Oct 2024
Wed, 16 Oct 2024 - Fri, 18 Oct 2024
Thu, 17 Oct 2024 - Sat, 19 Oct 2024
Thu, 17 Oct 2024 - Sun, 20 Oct 2024
Thu, 17 Oct 2024 - Sat, 19 Oct 2024
Thu, 17 Oct 2024 - Sat, 19 Oct 2024