ATTEND THE FASTEST GROWING AND MOST INTERACTIVE TMF & INSPECTION READINESS FORUM IN EUROPE!
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.
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
Director, Clinical Data Management
Danish Medicines Agency
Top Reasons to Attend:
- Hear first hand how the TMF Exchange Mechanism will help revolutionize the way we solve interoperability issues in eTMF platforms
All New Case Studies and Interactive Discussions: Sponsors and CROs share real experiences with TMFs allowing you to build on existing strategies to ensure continuous improvement.
GCP Regulatory Inspection Readiness Training Day
In this interactive, expert-led training course by the HSRAA, you will have the opportunity to test your current strategies, acquire tips and tricks from other sponsors and CROs, and identify any gaps in your inspection readiness.
100% Interactive Programme
This year, in order to create value for TMF industry professionals and Clinical Operational leaders alike, we bring you a discussion based agenda, to allow you to gain key takeaways from questions, debates and round tables.
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!"Document Manager, Novartis
"Extremely valuable; learnt a huge amount. The break out groups worked very well."Delegate 2015
"Good mix of speakers and complementary experiences"Delegate 2015
"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."Clinical QA Manager, GW Pharmaceuticals
"All of the speakers were very involved and open to questions."Delegate 2015
"This was a very valuable conference. It was very good with time for discussions and knowledge sharing. This is often what is missing at conferences with presentations from end to end."Delegate 2015
"I learned more about TMFs this week than I ever have. It was very informative on a practical level."Senior GCP Auditor, Celgene
"Extremely valuable! Especially from an Inspection Readiness stand point."Delegate 2015
"The Inspector presentation was very valuable as it gives us some visibility regarding the inspection trends."Delegate 2015
2018 Programme in Brief
100% INTERACTIVE AGENDA
Extensive research has told us that what our delegates value is interaction and knowledge sharing. So rather than give you two days of PowerPoint presentations, we have carefully crafted a unique agenda that allows you to capitalize on the knowledge of your peers, and fosters in depth discussions to formulate solutions to your most pressing challenges.
GCP REGULATORY INSPECTION READINESS TRAINING DAY
This interactive and information course, hosted by HSRAA, has been designed to provide insight and information to help archivists, records managers, information and document managers prepare for a regulatory inspection from a records management perspective. During this day we will cover Good Clinical Practice (GCP) and Trial Master File (TMF) Inspections.
NETWORKING DRINKS RECEPTION AND DINNER
We know that there are only so many hours you can really think about documentaion - which is why our conference always includes a fun night out with your new network too! This year we enjoy a three course meal on a classic boat cruise along the Amstel!
BEST PRACTICE IN ETMF INTEGRATION
Through case studies, round tables, workshops and targeted Q&A, you will be able to determine what the next steps are to optimising eTMF platforms for a new way of working!
THE WIDEST RANGE OF PHARMA REPRESENTATIVES IN ANY SPEAKER PANEL!
Hear from a GLOBAL Speaker Faculty, with Big Pharma and small biotechs alike coming together to Amsterdam to debate over best practice, CRO v Sponsor TMF management, scanning verifications and more!