This September, join us in Barcelona for Europe's fastest growing, most interactive and case-study led Trial Master File Conference!
Ensuring TMF completeness and inspection readiness in both a paper and electronic system has proven to be a difficult undertaking – especially given the number of complexities that can increase non-compliance! After extensive industry research, Pharma IQ have put together an agenda designed to get straight to the heart of the main challenges, and help you find the solutions!
Are you looking to:
- Represent a complete TMF and ensure inspector readiness? - The Danish Medicines Agency present a case study to ensure you are inspection ready
- Effectively manage internal and external correspondence? - UCB share their expertise
- Successfully convert to a cost-effective eTMF system? - Mitsubishi Tanabe share their expertise
- Ensure positive CRO oversight that ensures TMF completeness, quality and timely delivery? - Covance and Biomarin share their two differnt perspectives
- Ensure efficiency with a perfected interoperabilitystrategy? - Phlexglobal offer their indight
In this 100% case study and discussion based event, we are joined by industry experts from across pharma and regulatory bodies, who will help you solve all of your TMF challenges!
So what makes PharmaIQ's Trial Master Files conference different from others?
75% New Speakers Year on Year
A Focus on TMF QUALITY
We listened to your feedback and this year will be honing in on TMF pain points
‘What-If’ Round Tables
That each focus on a different emergency scenario – so you walk away knowing exactly how to handle this situation in real life
An intimate and snack-fueled way to knowledge share with peers
Concluding ‘Pub Quiz’
Designed to test what you’ve learned over the course of the conference. Keep your sheets as a reference guide to take back to the office with you!
2016 Speakers include:
Director-Vault eTMF Strategy
Clinical QA Manager
Clinical Inspection Readiness, Manager External Partnerships
Sr. Records Manager
Senior Vice President of Client Solutions
Competency Development Professional
Executive Director E-Solution Programs
Senior Clinical Trial Administrator
Mitsubishi Tanabe Pharma
Trial Master File System and Process Manager
Danish Medicines Agency
R&D Quality Assurance Auditor
Senior Systems Manager
Trial Master File Manager
Top Reasons to Attend:
Face-to-Face Q&A with the Danish Medicines Agency TMF expert Philip Lange Møller: Break down current trends, expectations and common pitfalls that will enable you to ensure regulatory compliance.
All New Case Studies and Interactive Discussions: Sponsors and CROs share real experiences with TMFs allowing you to build on and integrate to ensure continuous improvement.
TMF Optimisation Workshop – Designed to help you Improve the Overall Quality of Your TMF: You’ve got your TMF, you’ve got your SOP and you’ve got your instructions… what’s next? It’s time to work on improving your overall quality and efficiency!
CRO vs Sponsor Debate, Metrics Panel and Open Thought Forum: Benefit from a variety of innovative discussion forums, address major issues and advance your understanding of TMF challenges and opportunities.
Establish a framework for best practice and cost-effectively advance your TMF with top industry experts from Pfizer, Sanofi Pasteur, Quintiles, GSK, Janssen, CSL Behring, Novo Nordisk and more.
Join 100 industry experts at Trial Master Files Europe in Barcelona and gain a comprehensive understanding of your peers strategies. Share experiences, improve on standardisation measures and fully utlise your TMF as a trial management tool.
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!"
"Extremely valuable; learnt a huge amount. The break out groups worked very well."
"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."
"All of the speakers were very involved and open to questions."
"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."
"I learned more about TMFs this week than I ever have. It was very informative on a practical level."
"Extremely valuable! Especially from an Inspection Readiness stand point."
"The Inspector presentation was very valuable as it gives us some visibility regarding the inspection trends."
What to Expect
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.
New Regulator Input:
While Andrew Fisher has still contributed to the conference by means of content on ‘inspection readiness’, this year we will also have regulatory insight from the Danish Medicines Authority in the form of Philip Lange Møller, Medicines Inspector, Danish Medicines Agency. That means we have input from 2 regulators
CRO vs Sponsor Managed TMF Hear a CRO representative and a pharma TMF lead debate their unique benefits, and stir the pot with your own questions and points!
Live Mock Inspection!
This is just one of the many exciting new interactive sessions that we do that others don’t.
The WIDEST Range of Pharma representatives of any speaker panel!
Big pharma as well as SMEs!