Discounted tickets are available now!
New York Professional Events List
6th European Trial Master File Summit
Date
Link to Website
Organizer
Venue
Location
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 rivalled only by the calibre 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 scrutinised for poignancy
- Facilitated and informal peer-to-peer learning opportunities
- Broadly representative panels with complementary viewpoints
- 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 system quality through a defined structure and QC
- Monitor the TMF/eTMF process 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
Audience Breakdown
Trial Sponsors CRO Service Providers Sites
Manager VP/Director Regulatory Associate Coordinator/Records Manager C-level Specialist
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 conference is also of interest to:
|
|
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 system 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 system 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:
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:
Neil Bell, Head of Clinical Operations, AUTOLUS
Lisa Mulcahy, TMF Management Consultant, MULCAHY CONSULTING |
|
16:00 |
Workshop Day Concludes
|
DAY 2
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
|
|
9:45 |
Consider Best Practices to Prevent Critical Findings
Karen Roy, Senior Vice President, Client Solutions, PHLEXGLOBAL
|
|
10:30 |
Networking Break
|
|
11:00 |
Ensure a High-Quality TMF System Through Positive CRO/Sponsor Interactions and Oversight
Jamie Marie Toth, Head of TMF Operations, DAIICHI SANKYO
|
|
11:45 |
Transition From TMF to eTMF: Tips and Tools for Minimizing the Pains of Change
Patricia Santos-Serrao, RAC, Director, Clinical and Regulatory Solutions Pharmaceutical, Blood and Biologics, MASTERCONTROL
|
|
12:45 |
Networking Luncheon
|
|
13:45 |
Case Study Develop and Rollout a TMF Management Plan With CRO for Sandoz Biosimilar Clinical Development
Claudia Panitz, Head Regulatory Readiness and Archival/ GDO, NOVARTIS
|
|
14:30 |
Panel Utilise an eTMF System to Monitor All Aspects of the TMF Process, Vendors, Quality and Clinical Research Sites
Jeannette Dixon, Associate Director, Clinical Operations Quality Oversight, BIOGEN
Jeff Pilot, Senior Clinical Project Manager, NORGINE |
|
15:15 |
Networking Break
|
|
15:45 |
Take a Behind-the-Scenes Tour of Active eTMF Management
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
Lucy Hampshire, Director, Medicines Quality Organisation - Europe, ELI LILLY
Jennifer Maier, Associate Director, R&D Quality Compliance, ALEXION PHARMACEUTICALS |
|
17:15 |
Day One Concludes
|
DAY 3
8:30 |
Registration Opens and Continental Breakfast
|
|
9:00 |
Co-Chairs’ Recap of Day One
Karen Roy, Senior Vice President, Client Solutions, PHLEXGLOBAL
Vittoria Sparacio, Head, Clinical Documentation Operations, GLAXOSMITHKLINE |
|
9:15 |
Oversee an eTMF Process for a CRO-Run Study With Proven Processes and Tools
Kathie Clark, Vice President, Product Management, WINGSPAN TECHNOLOGY
Martin Hausten, Team Lead Global Document Specialist, Head of Global Document Quality Content, BOEHRINGER INGELHEIM |
|
10:00 |
Case Study CASE STUDY: Bolster eTMF System Compliance and Data Quality Though Metrics, Dashboards and Automation
Timothy Rafferty, eTMF Quality and Metrics Manager, ROCHE
|
|
10:45 |
Networking Break
|
|
11:15 |
Case Study Apply a Risk-Based Approach to Your TMF Process
Ruth Coll, Senior Clinical Program Manager, TRIZELL
|
|
12:00 |
Assure TMF System Quality Through the Engagement of People and Establishment of Processes and Systems
Dorte Frejwald Christiansen, TMF Lead, Principal Consultant, NNIT
|
|
12:45 |
Networking Luncheon
|
|
13:45 |
Case Study Define, Monitor and Remain Inspection-Ready
|
|
14:30 |
Case Study Document and Content Management Part of a Robust Quality Management System
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 Process
Nancy Meyerson–Hess, Associate Partner; Former Head of Clinical Operations and Compliance, ADMEDICUM BUSINESS FOR PATIENTS; GRUNENTHAL
|
|
16:30 |
Ensure TMF Completeness
Wendy Koç, Senior Manager Clinical Compliance, GILEAD SCIENCES
|
|
17:15 |
Conference Concludes
|
Please contact Marilyn Turner: +1 929 900 1853 for registations