Trial Master File and Inspection Readiness Conference
Conference Day One
8:20 am - 8:50 am
Registration and Coffee
9:00 am - 9:30 am
Chairwoman's Opening Remarks
9:30 am - 10:10 am
PRESENTATION: TMF - THE ROAD TO STANDARDISATION WITH CDISC
Peter Van Reusel -
Chief Standards Officer,
Clinical Data Interchange Standards Consortium
PRESENTATION: TMF - THE ROAD TO STANDARDISATION WITH CDISC
This session will focus on:
- Why is the TMF Reference Model Group affiliated with CDISC
- What is CDISC and what is a standard
- How are we implementing and transitioning the TMF group with CDISC
- What our current status is and what can we expect next
10:10 am - 10:50 am
PANEL DISCUSSION: THE SHIFT FROM REACTIONARY TO PREPARATORY TO MINIMISE INSPECTION FAILURE
Milos Stojkovic -
Senior Safety Specialist, Global Medical Affairs,
Smith & Nephew
Lena Luftensteiner - Clinical Trial Co-ordinator, AOP Health
Mihaela Nosca - Director Clinical Compliance and Inspection Readiness, Seqirus - A CSL Company
Malgorzata Okrasa - Associate Director, Operational Excellence, MSD
Preparation is the key to allow successful operations that minimise stress and risk, and ensure all bases are covered, regardless of whether submissions are incorporated into final studies.
- Encouraging change within the industry to instil a preparatory approach throughout operations and processes to enable a work environment geared towards readiness
- Enable a culture of readiness that can effectively react to industry or regulatory changes
- Understand how to mitigate resistance to change by understanding key obstacles and effective solutions to overcome them
- Hear from speakers as they share experiences and tools used when regulations appear to be vague, as this presents a key issue holding the industry back from developing
- Take advantage of having a proactive approach which recognises and instils change before regulators enforce them to stay one step ahead of the game
10:50 am - 11:30 am
CASE STUDY: MAINTAINING TMF AND SITE COLLABORATION AS ONE END TO END PROCESS
Martin Hausten -
Head of Global Document Quality Center,
Boehringer Ingelheim
CASE STUDY: MAINTAINING TMF AND SITE COLLABORATION AS ONE END TO END PROCESS
Focusing on principles that when considered can form the foundations to build a more effective, functional and collaborative culture around TMFs, this session will detail key strategies and groundworks to ensure relationships with stakeholders are considered as an end-to-end process whilst given the support needed to ensure collaboration is maximised.
- Quality by Design – Benefit for TMF
- Understanding key steps in the TMF & Site Collaboration process
- From process design to SOP authoring
- Develop a TMF and Site Collaboration process faceplate
- How active TMF management can contribute to speed and value in Clinical Development
11:30 am - 12:00 pm
Networking Coffee Break
12:00 pm - 12:30 pm
CASE STUDY: ARCHIVING – IS YOUR BRIDGE TO THE FUTURE SOLID ENOUGH?
Gergana Koutsarova -
Global TMF Process Owner,
AstraZeneca
- Scope of archived records and systems
- A continuous improvement
- Archiving Board
- Archiving metrics
12:30 pm - 2:00 pm
Roundtable Discussion
During this session, attendees will be given the chance to attend three roundtables discussion. The rotations will last 25 minutes each. The topics have been set to ensure you are prepared for Day 2’s Interactive Activity Session.
- MOCK INSPECTIONS
- SHOULD TMFs SIT IN THE QUALITY DEPARTMENT?
- STRUCTURE OF TMF TEAMS
- EXTERNAL PARTNERS
2:00 pm - 3:00 pm
Networking Lunch
3:00 pm - 4:00 pm
PANEL DISCUSSION: DATA, TMFS AND INSPECTIONS IN SITUATIONS OF CRISIS
Francis Crawley -
Executive Director,
Good Clinical Practice Alliance - Europe (GCPA)
The pandemic impacted operations globally and though most of us have passed through the eye of the storm, our friends in Ukraine are dealing with a different, but as challenging situation. This session will allow some wonderful peers to share their experiences and strategies used to enable operations to run ‘as normal as possible’ given the external pressures they are currently facing.
- Data integrity
- Impact on TMF
- Role and function of inspections during crisis
- Roles of the auditor and the monitor
- Ensuring the safety of trial participants and study integrity
4:00 pm - 4:30 pm
Networking Coffee Break
4:30 pm - 5:00 pm
CASE STUDY: BUILDING A STRONG TMF PERFORMANCE CULTURE THROUGH PROCESS, METRICS AND PEOPLE
Anne-Noelle Charles -
Director, Clinical Documentation Operations,
GlaxoSmithKline
- Why are the three pillars, Process, Metrics and People, at the heart of the GSK strategy?
- Understand how GSK embedded a TMF performance dialogue at all levels of the organisations, from study level to the leadership team
- Through their network of performance leads and mindset shift, identify how GSK implemented a risk-based approach and effectively share responsibilities in all aspects of process
5:00 pm - 5:30 pm
CASE STUDY: PIECING TOGETHER THE COMPLETENESS PUZZLE
Fiona Mackenzie -
Manager, TMF Operations,
Alnylam Pharmaceuticals
- Understand the importance of measuring and managing TMF Completeness, including ownership, metrics, resourcing and more
- Takeaway tips and best practices for approaches to tackling the task
