This training will give attendees an insight into the interpretation of GCP regulations by the European Medicines Agency (EMA) as they relate to the management of trial documents, focusing especially on clarification within the paper on disputed and ambiguous areas of trial master file (TMF) management.
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.
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
Course Provider
Eldin Rammell,
