FDA, EMA advise on risk-based monitoring in clinical trials
US and EU officials explained on Wednesday what their respective regulatory agencies look for in clinical trial risk-based monitoring (RBM) and how RBM can impact review times.
Under a cooperative agreement with the FDA, the Duke-Margolis Health Policy Center convened the public workshop in Washington, DC for a debate on improving the implementation of RBM in clinical trials by identifying how regulators can help with some of the current barriers to widespread adoption of RBM. Participants looked for clarification around how regulators’ approaches to RBM differ.
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