Brookwood Global 2026 Online Training Brochure

Contents 2
About Brookwood Global 3
UK Clinical Trial Reguslations 4
The UK Clinical Trial Regulations are Changing 4
A Guide to the UK Clinical Trial Regulations 2026. 4
Good Clinical Practice 5
Fundamentals of GCP 5
Essential GCP for Sponsors 6
GCP Refresher for Sponsors 7
GCP has Changed – what’s new in ICH E6(R3) 7
Essential GCP for Investigators 8
GCP Refresher for Investigators 9
GCP has Changed – E6(R3) for investigators 9
The Principles of GCP 10
Are You Ready for … a GCP Inspection? 10
Risk Management in Clinical Trials 10
EU Clinical Trial Regulation 11
Essential Guide to the EU Clinical Trial Regulation 11
Managing and Reporting Serious Breaches of the EU Clinical Trial Regulation 12
CTR for ALL – a high-level overview of the EU CTR 12
Clinical Investigator Site Awareness: the EU CTR 12
Non-interventional Studies 13
Non-interventional Studies, General Principles 13
NIS, Practical Aspects 13
NIS Essentials for Investigators 13
Pharmacovigilance 14
Are You Ready for … a PV Inspection? 14
PV for ALL 14
Essential PV – know PV 14
PV for the Local Safety Contact and L-QPPV 15
PV Refresher 15
Essential Safety Reporting for the Investigator Site 15
The Principles of the General Data Protection Regulation (GDPR) 16
GCP for Clinical Data Management 16
GCP for Clinical Laboratories 16
Good Manufacturing Practice 17
Good Distribution Practice 18
Data Integrity 19

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