ICH E8(R1) - US edition Masterclass
03 & 04 November, 2022
ICH E8(R1) Masterclass is the umbrella guideline that maps to all the ICH “E” family, including ICH E6(R3), Good Clinical Practice
ICH E8(R1) Masterclass is the umbrella guideline that maps to all the ICH “E” family, including ICH E6(R3), Good Clinical Practice.
03 & 04 November, 2022, Virtual
Time Zone: Eastern Standard Time (EST) / UTC−05:00
ICH E8(R1) is the umbrella guideline that maps to all the ICH “E” family, including ICH E6(R3), Good Clinical Practice. The revision modernizes clinical trial design, planning, management, conduct, and reporting and introduces the idea of quality as data being fit for purpose, which is ensuring the protection of study participants, the integrity of the data and reliability of the results, and the ability of the trials to meet their objectives. The key purpose is to design quality into clinical trials, which is supported by the establishment of an appropriate framework for the identification and review of Critical to Quality factors at the time of design and planning of the study, and throughout its conduct, analysis, and reporting.
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Who should attend?
This course is applicable for all clinical research professionals involved with the design, planning, and conduct of clinical trials.
"High attention to detail in course content and very well delivered"
Product Development Manager
"Very good training led by two knowledgeable and open experts. Excellent insight given on many complex topics. Interactive and highly useful"
USP PD Team Manager
"Great course, impressed with the knowledge of the trainers and ability to answer wide variety of questions!"
Manager, Senior Investigator
MT Sword Laboratories (BMS)
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