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 16 For details of packages for training larger groups contact us at info@brookwood-global.com The Principles of the General Data Protection Regulation (GDPR) This 30-minute online on-demand training with a quiz and certification is an ideal way for those processing personal data to learn about the latest requirements for data protection. Content includes: • Key roles • Definitions of personal data • Applicability of the GDPR and exemptions • Consent and rights of Data Subjects • Legal basis for processing • Obligations towards Data Subjects • Risk assessment • Data transfer outside EEA • Record keeping • Data security and storage • The Data Protection Officer • Data protection ‘by design and default’ • Audits • Managing breaches, compensation and penalties • Data protection checklist • Specific content on the impact of GDPR on pharmacovigilance and clinical trials. GDPR GCP for Clinical Laboratories This 30-minute narrated course is ideal for laboratory staff needing an insight into GCLP requirements, as well as sponsors’ monitors, medical experts and auditors who utilize laboratory services in clinical trials. It is based on the guidance given in the European Medicines Agency “Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples”, adopted by the GCP Inspectors Working Group in 2012. It covers the most important aspects in the Reflection Paper and offers practical advice on how and when a laboratory should comply. The program also covers some GCP basics to fulfil the requirement that laboratory staff have relevant GCP knowledge. GCLP GCP for Clinical Data Management This online on-demand training with a quiz and certification is a fun interactive way for data management personnel to learn about their GCP responsibilities. Content includes: • Qualifications, training, SOPs • Computerized systems • Data flow and source data quality • Data collection, quality and management • Documentation • Using CROs • Risk register and risk-based approaches • GCP checklist for clinical data management. CDM
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