Visit www.brookwood-global.com for further details and to order online GCLP Regs RM MD GMP NIS CDM PV GDPR GCP Stats 2 Contents Introduction Our online training courses: The UK Clinical Trial Regulations are Changing ......................................... 4 A Guide to the UK Clinical Trial Regulations 2026 .............................. 4 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 GCP for All .............................................. 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 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, General Principles ............................... 13 NIS, Practical Aspects ......................... 13 NIS Essentials for Investigators ... 13 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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