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, we 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!
Top Reasons to Attend:
- Face-to-Face Q&A with the Danish Medicines Agency TMF expert Philip Lange Moller: 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.
"Extremely valuable; learnt a huge amount. The break out groups worked very well."Delegate 2015
"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! Especially from an Inspection Readiness stand point."Delegate 2015
Register at ASDEvents and receive 15% discount.
Early-confirmed speakers:
- Ivan Walrath, Head of Audit and Inspection Quality, Pfizer
- Linda Hoppe, Trial Master File Manager, UCB
- Alex Dingenouts, Senior Systems Manager, Astellas
- Raquel Pensado, R&D Quality Assurance Auditor, Almirall
- Philip Lange Møller, Medicines Inspector, Danish Medicines Agency
- Scott McCulloch, TMF Specialist, BioMarin Pharmaceuticals
- Eldin Rammell, Managing Director, Rammell Consulting
- Anne-Mette Varney, Trial Master File System and Process Manager, Novo Nordisk
- Ashley Cole, Senior Clinical Trial Administrator, Mitsubishi Tanabe Pharma
- Craig Picinich, Executive Director E-Solution Programs, Covance
- Maria Nymann Jensen, Competency Development Professional, Novo Nordisk
- Karen Roy, Senior Vice President of Client Solutions, Phlexglobal
- Alina Brezneva, Sr. Records Manager, Astellas
- Senta Habenich, Clinical Inspection Readiness, Manager External Partnerships, Shire
Register at ASDEvents and receive 15% discount.
Please fill in your name and email to receive the conference agenda of this event.
Pre-Conference Focus Day - Monday 12th September 2016
- Workshop A: TMF Interoperability – Overcoming the Challenges!
09:00-11:30 - Workshop B: TMF Optimisation – The Next Hurdle
12:00-14:30
Conference Day One - Tuesday 13th September 2016
- Including: Morning & Afternoon Coffee Break, Networking Lunch
Conference Day Two - Wednesday 14th September 2016
- Including: Morning & Afternoon Coffee Break, Networking Lunch
The agenda is available as PDF under dwonloads at the right side of the page.
Register at ASDEvents and receive
15% discount.
Venue
The venue is not yet available for this event.
Follow this event to be informed when the venue is available and stay informed on other changes.
Venue
Hotel Alimara Barcelona126 Berruguete, Barcelona,
08035, Spain
Website:
http://www.alimarahotel.com/en/homePhone: +(34) 93 427 00 00
Fax: +(34) 93 427 92 92
AccommodationDiscounted Bedrooms:
Travel and accommodation is not included in the registration fee. However a number of discounted bedrooms have been reserved at the Hotel Alimara Barcelona on the 12th and 13th September 2016. Please book via the hotel web link:
https://form.jotformeu.com/61614194989368Prices start from €93 per night, including breakfast and tax, excluding €1.21 city tax per night. There is limited availability until the 30th August, so we do encourage attendees to book early to avoid disappointment.
Please note: We will never recommend, approve or appoint any third party rooming service to act on our behalf. Please be extremely wary if you are approached by any such companies. We will always endeavour to negotiate the best available rates for you so please use the Hotel´s website link provided.
Register at ASDEvents and receive
15% discount.
