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Download The Draft Agenda | Trial Master File and Inspection Readiness

Download The Draft Agenda | Trial Master File and Inspection Readiness

Whilst we put together the agenda for the 2019 TMF Forum - please view THE DRAFT AGENDA to get an OVERVIEW for the topics and interactive opportunities TO BE presented over the 4 days.

Join Europe's fastest growing and most interactive TMF forum to:

  • Hear first hand from Pfizer to understand how to maintain an accurate and complete eTMF system to avoid delays in the inspection process
  • Learn from Novo Nordisk to understand how assure regulatory compliance by implementing a centralised TMF oversight in your organisation
  • Determine how to utilize your documentation during an eTMF transition, by assigning sponsor and CRO responsibilities
  • Hear insight from Daiichi Sanyko and understand how to keep your eTMF system contemporaneous by following a continuous improvement process (CIP) model

“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
Interoperability: The Top 5 Benefits and Burdens of Utilising the CRO eTMF

Interoperability: The Top 5 Benefits and Burdens of Utilising the CRO eTMF

Process and Quality, Quintiles and Pharma IQ take a closer look at how a modern day global contract research organisation (CMO) is approaching eTMF and assess the top 5 benefits and burdens of utilising the CMO’s electronic trial master files.

Trial Master File Inspection Readiness: CRO and Sponsor Perspectives

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.
Top Challenges with Late Stage Trial Master Files

Top Challenges with Late Stage Trial Master Files

The transition from a paper to an electronic Trial Master File (TMF) system is a significant task. In many cases, some pharma and biotech firms (sponsors) may find that they are in the late stages of digitising their TMF system resulting in some documents being left as hard copies. Ahead of the 2017 Trial Master File conference we examine the top challenges that are attached to operating trials with a late stage TMF.