FDA and EMA Plan Joint Workshop on PRIME and Breakthrough Submissions

The European Medicines Agency and the FDA will host a joint workshop in November to discuss quality challenges and approaches that can be used to prepare quality data packages for use in accelerated drug development.

The London workshop will include discussions between stakeholders and regulators on product characterization, validation and stability testing and ways to identify quality issues early on in the development process.

The agencies will consider developing follow-up guidance based on insights gained from the workshop.