Visit www.brookwood-global.com for further details and to order online • ONLINE TRAINING • GCLP Regs RM MD GMP NIS CDM PV GDPR GCP Stats 14 Are You Ready for … a PV Inspection? This online, on-demand inspection readiness training takes around 35 minutes to complete. It is ideal for those facing a pharmacovigilance (PV) inspection, including the safety and clinical operations departments. Developed with Dr Lisbeth Tofte Hemmingsen, a well-respected PV and QA expert who has huge experience of inspections. • Based on answers to a series of questions relating to inspections • Packed with information, ‘Words of Advice’ and practical tips • Personalized, narrated or read-only options • Highly interactive • Can be done on PCs, Macs, laptops and mobile devices 24/7/365 • Comes with a downloadable self-checklist. PV PV for ALL This short online PV training is for an entire organization’s staff. It can be fully customized. Run it on your own server or let us manage it for you. Content includes: • Types of product safety information that may be encountered • Who might report safety information • How and when to report to the Local Safety Contact • Key information to be obtained. PV PV Essential PV – know PV This online training covers essential PV in more depth. It is approximately 60 minutes long and is ideal for those who need a more detailed knowledge of PV. Content includes: • What is and what governs PV • Roles and responsibilities • Key PV process steps; safety information and its capture • Product safety oversight • ADRs – basic facts, solicited v unsolicited reports • Expedited individual case safety reporting • MedDRA coding • Periodic safety reporting, PSURs, PBRERs, DSURs • Risk management planning • Safety signals • Reference safety information • PV system master file • Inspections. For details of packages for training larger groups contact us at info@brookwood-global.com We facilitate Webinars on a variety of subjects relating to clinical trials.Be sure to check the website frequently to view our forthcoming webinar events.
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