For companies looking to develop new therapies or improve existing ones, and for the regulators overseeing them, striking right balance between potential benefits to patients and an appropriate level of risk is critical. The drive to innovate, develop new and better products, and help patients live healthier lives has led to numerous medical breakthroughs. But it is just as imperative that products are as safe as possible, and that where there are associated risks, they are identified and deemed acceptable.
Understanding the principles of risk management is crucial in the regulatory world. And while the concept of balancing benefit and risk may be straightforward, in practice, risk management is not only complex but also rapidly changing as it is subject to constant and…
