The need for a risk evaluation and mitigation strategy (REMS) or a risk management plan (RMP) is essential to ensure risk–benefit balance for complex cellular therapies. Hear from our Expert Dr. Vineet Kacker as he discusses:
- Importance of early planning to ensure product safety and well-planned risk mitigation strategies along with active engagement with regulatory authorities.
- Early detection of the risks, characterization, and development of mitigation plans in parallel with appropriate risk–benefit assessment and communication should continue throughout the development process.
- How the Information collected may result in a change in risk–benefit profile, and timely action can prevent a lot of complexities?