Roundtable Discussion

Time: 10:00 am
day: Day 2

Details:

Following a series of case studies, this is your opportunity to engage and interact with your fellow colleagues to share your ideas, challenges and seek solutions together. Select the topic of choice for a solution-led discussion, and we will feedback for Q&A towards the end of the session to create a comprehensive action plan for your team.

Topic 1: Exploring FDA Perspectives to Ensure Compliance & Clear Communication With CDER

• Validating thorough documentation and testing of production processes
• Gathering the latest guidance for safety, purity, and monitoring

Topic 2: Examining Structural Complexity of Oligonucleotides With the EMA

• Navigating technical complexity of developing analytical methods
• Improving reliability of characterization methods for oligonucleotides
• Bringing oligonucleotides to market safely to improve future acceptance