Understanding and Interpreting the EMA Reflection Paper on GCP Compliance in Relation to Trial Master Files (paper and/or electronic) for Management, Audit and Inspection of Clinical Trials

Why Should You Attend:

The regulatory requirements pertaining to the maintenance and management of the trial master file is often poorly understood. This is especially so for electronic document management where issues such as document scanning, electronic mail and electronic archiving are regularly misunderstood. In some regulatory jurisdictions, guidance in this area is very scarce or even non-existent. The release by the EMA of a reflection paper on these topics is therefore to be welcomed.
However, being able to understand, interpret and put into context an agency reflection paper can be challenging.

This webinar will not be a line by line review of the reflection paper but will rather highlight those areas that differ substantially with prior common understanding of an issue. It will also include a review and an interpretation of particularly important areas of clarification that should be noted. Issues that still remain contentious will be discussed.

This session will also review emerging responses from industry to the reflection paper and will provide an update on current status and next steps.

Learning Objective:

At the end of this webinar, participants will have a better understanding of the expectations from the EMA for trial master files and electronic TMF systems. Whilst the reflection paper only represents the view of the EMA, the content of this webinar will provide sufficient guidance to be applied globally.

Areas Covered in the Webinar:

• Overview of reflection paper
• Expectation for TMFs and eTMFs
• Structure and organization of documents
• Document scanning and destruction
• Quality control
• Requirement for signatures
• Electronic investigator site files
• Management of correspondence, including email
• Maintenance of the TMF
• Inspections
• Archiving and digital preservation

Who will Benefit:

This webinar will provide valuable assistance to the following personnel:

• Clinical IT Project Managers
• Clinical Operations Management
• Clinical Project Managers
• TMF Specialists
• Records Managers
• Clinical Compliance Officers / Auditors
• Process Development staff

Instructor Profile:

Eldin Rammell, is an independent records management consultant with over 25 years experience within the life sciences sector. Gaining experience within major pharmaceutical companies, he has managed on site and off site records centres and archives and overseen major records management projects. During the last 10 years, he has been the owner and principal consultant at Rammell Consulting Ltd, providing bespoke consultancy in clinical records management. He has been engaged as a consultant on several eTMF implementation projects for clients ranging from multinational pharmaceutical companies to small biotechnology companies. He is recognized as an industry key opinion leader in the area of TMF management and is a regular conference speaker. His engagement with a wide range of organizations globally puts him in a unique position regarding interpretation of regulatory requirements by industry and agencies.

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