As science and technology advance, pharmaceutical regulatory science is evolving in a way that minimizes uncertainty in the development process and shapes an environment where the actual data use.

The Regulatory Agencies around the world are moving from the traditional approach of determining the drug characteristics and QC based on the test results conducted in the development stage to drug monitoring throughout the lifecycle utilizing RBM, RWE etc.

In the case of generic dosage & formulation development applying various advanced technologies, a bioequivalence evaluation considering the formulation characteristics is essential. This provides the basis for the safe use of drugs in Korea where the proportion of generics is high.

In this two-day workshop, we would like to share vivid examples from the industry along with the voices of regulatory agencies on continuous quality management throughout the drug life cycle, actual use of data, and equivalence evaluation reflecting the formulation characteristics, which are currently being actively discussed in accordance with the advancement of technology.