2020 - Clinical Study Risk Management including Compliance During The COVID-19

Understand the new requirements for risk management in clinical trials including the latest EMA and FDA guidance on risk management during Covid-19
Define the regulations and guidelines which cover risk management and Covid-19 applied to clinical study-level risk management
Consider the elements of QM system are and what a regulatory inspector would expect to be in place for clinical trials
Have explained key risk-based process/tools and techniques including RBM and FDA and EMA recommendations during Covid-10
Review a risk-based approach to protocol design
Hear best practice of these new management risk requirements during Covid-19