Brookwood Global Products Brochure 2020

• ELECTRONIC BOOKS • To evaluate the training, contact us by email info@brookwood-global.com @ GCP ProfessorDavidHutchinson 15Golden IND/GCP Rules for Investigators ProfessorDavidHutchinson 12Golden ISO14155:2011 Rules forMedicalDeviceTrials DavidHutchinsonand JorisBannenburg 10 Golden GCP Rules for Trial Pharmacists This book aims to help the trial pharmacist understand the GCP requirements relevant to handling study medications in a clinical trial. The requirements in this book apply most to studies on unlicensed medicinal products, where responsibility for product accountability has been delegated to a trial pharmacist. 15 Golden IND/GCP Rules for Investigators This quick and easy-to-read, illustrated, ‘bullet point’ guide will help investigator site personnel comply with ICH GCP investigator responsibilities and the US Code of Federal Regulations 21 CFR Part 312, which applies to all studies performed in accordance with a US Investigational New Drug Application. 12 Golden ISO14155:2011 Rules for Medical Device Trials Anyone involved in clinical trials on medical devices should read this easy-to-read, ‘bullet point’ guide. New rules regarding the clinical investigation of medical devices for human subjects have been broken down into digestible chunks, providing the relevant requirements and some practical advice to facilitate regulatory compliance.