Outlining Key Regulatory Considerations for Industry to Avoid Regulatory Pushback
Time: 3:30 pm - 5:30 pm
day: Pre-Conference Workshop Day – Workshop E
The cell therapy field offers remarkable opportunities for overcoming the limitations of other therapies. However, this field is new and constantly evolving, accordingly there are many unique biological, clinical and regulatory challenges. This workshop focuses on the latter and will open the channel of conversation between regulatory experts and those involved in cell therapy research.
- Define the best approach to submitting filings with regulatory bodies (i.e. FDA & EMA) to get seamless acceptance of analytical protocols
- Address the need for consensus on core regulatory elements for the sound development of cell therapy products
- Share experience and advice regarding key pain points