On-site Workshop Overview
規制当局からの承認方法は、ますます厳しくなり多くの時間を必要とするようになっています。適切な規制対応戦略を未構築のままでは、多くの時間と費用の浪費するだけでなく、最悪の場合には、開発計画の失敗や大幅な遅延に繋がる恐れがあります。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
