TMF Management, Oversight and Inspection Experience

NEW OFFERING! This course teaches you oversight strategies for ensuring that you can sustain your inspection readiness throughout the clinical trial development process.

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Overview

For many organisations, clinical trial regulatory inspections are obligatory for achieving new, or maintaining existing market authorisations. However, it can be challenging for organisations to sustain the required level of TMF preparedness while simultaneously dealing with data integrity, data privacy and Good Clinical Practice (GCP).

This course shares with you TMF management and oversight strategies for ensuring that you can sustain your TMF inspection readiness throughout the clinical trial development process.

Using practical examples, we will provide insights into helping your organisation prepare your tMF for an inspection in this digital era.

We will also show you those areas of TMF quality, data integrity and process improvement where you should focus your attention if you are to be ready to meet specific EMA, FDA and MHRA requirements.

Who should attend?

This course is designed for professionals in academia and in the pharmaceutical, medical and biotechnology industries who are:
- Clinical operations representatives
- CROs, CMOs and service providers
- Document and records managers
- Clinical project managers
- Internal/external auditors
- Clinical documentation managers
- IT and support personnel
- Quality assurance and compliance professionals
- Regulatory operations representatives
- Standards implementation specialists and associates
- Validation professionals
- Regulatory compliance specialists

Learning objectives

On completing this course, participants will be able to:
- Identify the key areas of focus for inspection of the TMF
- Ensure the organisation can maintain TMF that are inspection-ready at all times
- Assess the differences and similarities between various authority inspections of the TMF
- Determine the impact GDPR has on managing Clinical Trial records and the TMF processes
- Apply a risk-based approach to planning and conducting audits of the TMF

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