Leaving Sierra Leone for the first time, 16-year-old Kelvin Doe flew to the US to participate in MIT's fabled practitioner's program, where he demo-ed his soldered and duct-taped radio hardware to admiring undergrads.
This roundtable will consist of several 15-20 min short talks describing recent regulatory experiences with QbD filings. Afterwards, panelists will lead a discussion on current and future regulatory strategies for implementing QbD. Session chairs to strive
Talks in this session will cover the considerations and approaches for managing risk in the context of QbD principles. Talks will include identifying and assessing risk and effectively managing it through understanding CQAs and process design space. Understanding and mitigating the risk
This session will focus on how best to leverage prior process, analytical and formulation knowledge toward acceleration of drug substance and drug product manufacture. The value of clear understanding of the link between process parameters and CQAs will also be explored. Some examples c
Application of QbD principles and methods can present special challenges when working with external CRO’s, CMO’s and other external partners. This session will cover experiences and potential approaches for managing QbD application in this important interface.
Talks in this session will discuss approaches for accelerating clinical and commercial development by quickly developing phase appropriate formulations.
