On-site Workshop Overview
Regulatory approval procedures are becoming increasingly stringent and time-consuming. Not having the right regulatory strategy in place will cost time and money, and may result in the failure or delay of your drug development program. It relayed to potential of Generative AI how it can help overcome those regulatory challenges. The emergence of Generative Artificial Intelligence (Gen AI) has created a huge wave in Regulatory industry with high interest to explore novel ways of working in new era of regulatory writing and strategy.
In this workshop, you can see how you can increase your program’s chance of expedited success for FDA IND submissions with Certara’s regulatory expert and Certara AI. Proactively partner with Certara that will evaluate your program and provide tailored regulatory strategies while ensuring your program’s regulatory compliance with maximum efficiency.
Date & Time
9:20am – 11:40am , Friday, May 10
Sessions
- Navigating FDA’s pre-IND and IND submission process to initiate a Phase 1 study in the US
- Certara.AI GPT for Regulatory Writing and submission
For whom will the workshop be beneficial?
Regulatory Writer, Regulatory Affair experts in pharmaceutical companies who aim to submit to global regulatory agency.
Location
Certara Korea Office (ASEM Tower in Seoul)
Registration fee
Free
The number of seats
20 seats (Please note that we will close the registration if we reach full capacity)
Event flyer in Korean
Download the flyer in Korean