ATTEND THE FASTEST GROWING AND MOST INTERACTIVE TMF & INSPECTION READINESS FORUM IN EUROPE!
Preparing for an inspection remains one of the biggest challenges in clinical studies. There is no one way to prepare a TMF nor work with eTMF platforms, making it vital to identify key best practices and the right approaches to preparing your TMF for inspection.
Through a 100% interactive programme, the conference will focus on TMF inspection readiness, eTMF integration and control, debate over best practice, understand CRO v sponsor TMF management and scanning and documentation verifications. This event is the only platform where TMF and Documentation Managers can learn to exploit the performance of their TMF systems to improve inspection preparedness, optimise systems and streamline performances.Download Agenda
2018's Expert Speakers and Facilitators Include:
TMF Reference Model Steering Committee Member and eTMF-EMS Sub-group Co-chair
TMF Reference Model
Head of TMF Operations
Director, GCP Quality, and TMF RM SC Member
Head of Records Management
Director, Clinical and Regulatory Solutions
Senior Document Management Specialist
Clinical Research specialist (Clinical Documentation)
International Project Manager Clinical Operations
Head of TMF Operations Study Delivery Management
Head of TMF Operations
Director, Clinical Data Management
Danish Medicines Agency
Global Documentation Compliance Manager
Top Reasons to Attend:
- Hear first hand how the TMF Exchange Mechanism will help revolutionise the way we solve interoperability issues in eTMF platforms
Strengthen your eTMF strategy with all new Case Studies and Interactive Discussions: Sponsors and CROs share real experiences with their TMFs so you can ensure your TMF process improvement.
Ensure you are 100% Inspection ready with our Inspection Readiness Training Day. Take advantage of the opportunity to test your current strategies, acquire tips and tricks from the HSRAA and attendees to identify any gaps in your inspection readiness.
Get those answers you've been desperately seeking! This year's 100% Interactive Programme delivers a discussion based agenda that is the perfect industry platform for you to gain key takeaways and solutions to your biggest challenges.
What Others Have to Say
"Good mix of experience from different perspectives (sponsors, CROs, MHRA) made the event extremely valuable. Overall level of expertise and experience of all speakers was very high!"Novartis
"I am so glad I did not miss this one! Highly relevant content, very helpful. Overall, a high standard of people ready to interact and discuss."GW Pharmaceuticals
"I learned more about TMFs this week than I ever have. It was very informative on a practical level."Celgene
“Conference content was up to date, great information shared by industry leaders and a good networking opportunity”Veeva
“This event has been inspiring. All participants come in a spirit to learn from each other and to establish a common understanding of TMF Requirements”Shire
“Great event format with brilliant diversity of speakers”OPKO
Being Inspection Ready: Top Tips And Warnings
If you were handed with a notice for a clinical trial inspection plan right now, how would you react? - With a feeling of asserted confidence or a rush of slight concern? Wherever you think you would stand on this spectrum, use this infographic to learn from your peer's mistakes. Pharma IQ invites the expertise of Andy Fisher Senior GCP Inspector MHRA on a list of common TMF failings.
Alongside a number of other EU member states, Andy was recently involved in drafting guidance that the EMA is due to publish shortly. This draft guidance for TMF will replace what is currently in volume 10.
What Lies Ahead for Clinical Data Management?
Collecting, storing and curating the vast quantities of scientific data in existence is not just important for regulatory submissions, but is also vital for ongoing pharma research and clinical trials. Carole L Palmer, a professor of library and information science at the University of Illinois, share her views on the matter and discussed the key issues being overlooked by most organisations
Implementing a Robust eTMF System - What to Consider
In this exclusive Pharma interview Martin Thorley, TMF Content and Integration Lead at Pfizer, shares his key considerations to make when implementing an eTMF system and the implementation steps that impact eTMF inspection readiness. Thorley also reveals his key lessons learned after implementation.
Trial Master File Inspection Readiness: CRO and Sponsor Perspectives
Pharma IQ gathered the perspectives of both the CRO and the sponsor in regards to the burning topic of inspection readiness when it comes to Trial Master Files.