PharmaSchool: The Grey Guide

Please contact Jo Burmester at jo.burmester@pharmaschool.co.uk to find out more about in-house courses and discuss your specific needs.

Course Code: GGL013

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Duration: 1 or 2 Days

Description:

In September 2012 the UK Regulatory Authority, the Medicines and Healthcare products Regulatory Authority (MHRA) published the “Good Clinical Practice Guide” otherwise known as the Grey Guide. This course provides an overview of the contents, key requirements and advice contained in this essential book.

Who it is suitable for:

This course is essential for anyone working in clinical trials involving UK sites.

Example content:

NB: This content can be tailored to the audience with emphasis placed on the most relevant sections, and non-relevant sections reduced or omitted.

Background, Development and Purpose of the Grey Guide

Sponsor Oversight

Sponsor responsibilities
What does oversight mean?
How can we demonstrate oversight?

Clinical Trial Approvals in the UK

CTAs
Ethical approval
Risk based approaches

Key Trial Documentation

Requirements for documentation
Generation of documentation
Maintenance of documentation
Trial Master File and archiving

Pharmacovigilance

Reporting requirements
Ongoing safety evaluation
Development Safety Update Reports

IMP

Manufacturing requirements
Management of IMP
Non-IMPs

Monitoring

Requirements
Strategy
Activities
Output

Data Management

Database
Data capture
Data validation

Statistics

Processes and procedures
Protocol design
Analysis

Investigator Sites

Investigator site research team
Site set-up
During the study

Clinical Trial Samples

Logistics
Processing and data reporting
Quality

Quality Systems

Training
QC
QA

GCP Inspections

Types of inspections
Inspection process
Responding to inspection findings
Tips for preparing

Electronic systems in clinical trial management

 

We can also cover if relevant:

Phase I clinical trials

Accreditation
Approvals
Processes and procedures

Considerations for Advanced Therapy Medicinal Products

Customised In-house Courses are designed for organisations wishing
to train a group of your employees at a location of your choice.
For information about Open Courses click here or for
online learning click here

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