PharmaSchool: GCP Update

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: GGL002

Enquire about course | Previous Feedback

Duration: 1 day

Description
Clinical Research is a constantly evolving field and the regulatory requirements change frequently. In order to stay up to date and maintain your GCP knowledge it is important to receive regular refresher and update training. This course provides a refresher on GCP requirements, an update on recent changes to relevant legislation and guidance and an indication of future changes planned. The course is designed to:

Refresh knowledge of current guidance and legislation
Provide an update on recent changes and their implications for trial conduct
Facilitate discussion with colleagues in the field to learn from others’ experiences
Raise awareness of future changes planned.

Who is the course suitable for?
Anyone working in clinical research with existing knowledge of GCP requirements who needs an update course for operational or regulatory reasons. For example:

CRAs, CTAs and Project Managers
Clinical Trials Supplies Staff
Medical Advisers
Data Managers
Investigators
Study Nurses

Course Content:

Refresher and update on ICH

ICH GCP Refresher
ICH GCP Addendum key changes and implications

European Clinical Research

Summary of Current Legislation and Guidance with emphasis on recent additions
New EU Legislation current status and hot topics
New and updated Guidance documents supporting EU Clinical Trials Regulation

 UK Clinical Research 

Refresher on UK Legislation
MHRA Grey Guide overview and hot topics
Approvals in the UK

FDA Update

New Guidances overview and implications

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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Previous Course Feedback: GCP Update
Customer: CRO
Number of Participants: 20
How well fulfilled were your personal objectives for this course?
Fully (85%)
Well (15%)
Not Very Well (0%)
Not At All (0%)
How satisfied were you with the Trainer's Style & Knowledge?
Great Deal (75%)
Fair amount (25%)
Not Much (0%)
None At All (0%)
How much have you learned that you will be able to apply to your job?
Great Deal (80%)
Fair amount (20%)
Not Much (0%)
None At All (0%)
Rate the course overall on the scale 10: Excellent, 0: Poor
Average score: 9.6
Participant Feedback :
Showed me how essential it is to keep up to date
I was not aware of how things had progressed until this course
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