Navigating Varying Regulatory Guidance to Inform ADC Clinical Studies & Meet Global Regulatory Requirements
Time: 9:03 am
day: Pre-Conference Workshop Day
Details:
The biggest roadblock in developing ADCs in Asia is not having enough regulatory guidance from other agencies. This is especially important when trying to run clinical trials in multiple countries while adhering to varying regulatory guidelines. This interactive session will give you a holistic overview of varying government regulations and how to follow them to confidently meet expectations from agencies.
Join this workshop to:
- Understand how to jump over regulatory hurdles in the APAC region
- Examine the differing regulatory requirements of the FDA, EMA, NMPA, and more
- Assess the best way to gain IND approval to kickstart your clinical trials
- Analyze regulatory expectations from a CMC aspect • Focus on regulatory harmonization across the globe
