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 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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