What are the Key Components of ICH Q9 in Cancer Treatment?
ICH Q9 outlines several key components essential in the context of cancer treatment:
Risk Assessment: Identifying and analyzing potential hazards related to cancer drug quality. Risk Control: Implementing measures to mitigate identified risks, such as stringent quality control tests and adherence to manufacturing protocols. Risk Communication: Ensuring clear communication among stakeholders, including healthcare providers, patients, and regulatory bodies, about potential risks and the measures in place to address them. Risk Review: Continuously monitoring and reviewing risk management processes to ensure their effectiveness and make necessary adjustments.
