ComplianceOnline

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

Instructor: Eldin Rammell
Product ID: 703281
  • Duration: 60 Min

recorded version

$229.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$299.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-565-8542

Email: customercare@complianceonline.com

Read Frequently Asked Questions

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.

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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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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