Navigating Challenges in CMC Package Submissions
Time: 11:30 am
day: Conference Day Two
Details:
- Addressing the challenge of limited batch data, including the proposal to manufacture additional batches for compatibility testing
- Emphasizing the need for forward-thinking strategies in transitioning from experimental processes to commercially viable ones
- Exploring the regulatory landscape and how regulatory agencies, such as the FDA, respond to innovative approaches
- Highlighting the importance of risk assessment in justifying the analytical approach and how this can influence regulatory decision-making
