1:00pm Workshop D: Understanding How to Conduct Clinical Trials to Meet Regulatory Expectations & Gain Approval
Time: 1:00 pm
day: Workshop Day Track B P2
Details:
The increased regulatory scrutiny on cell therapy means the need to better understand what regulatory guidelines need to be met, how to meet regulatory expectations and more. Additionally, with the FDA releasing new guidance for cell therapy development, there are a lot of questions.
Join this workshop to:
- Unpack the new guidance and understand what it means for your trials
- Analyze what prevents the regulatory agencies from approving certain trials and products
- Understand what a successful IND submission looks like to ensure your IND is accepted
- Harmonize global regulatory requirements to ensure approval globally
- Interpret regulatory guidance and learn from examples on how to apply the guidance
