Webinar "Integrated addendum to ICH E6 (R1): guideline on Good Clinical Practice E6 (R2)"
The aim of the new addendum is introducing improved and more effective approaches to design development, clinical trials, monitoring of their progress, documentation and reporting, and standards for the maintenance of electronic documentation and mandatory documents.
What will we discuss in Webinar?
Quality and Risk Management
Preliminary assessment of possible risks specific to the study
Introduction of new technological processes and tools, subject to the guarantee of the protection of the subject and reliability of the results of the study
For drug developers, pharmaceutical and biotech companies, clinical trial sponsors and marketing authorization holders, participants of the clinical trial market, doctors.
Irina Nikitina, QA and Training Manager, IPHARMA