Through the workshops and sessions of Regulator Updates deals with the rapidly changing clinical trial

regulatory environment, participants will have information on clinical trials regulation status, IND, and

clinical trial strategies in various countries including Korea, Japan and China. In particular, several

sessions from the MFDS (The Ministry of Food and Drug Safety) are scheduled this year.

*Please find the attached Target Audience documents by topic.

- Workshop 1. Biologics CMC for IND [September 17th]
- Workshop 3. How to Manage Safety in Clinical Development; Lessons Learned [September 17th]
- Session 1. Impact of NMPA Reform in China [September 18th]
- Session 1. Regulatory Updates on Japan [September 18th]
- Session 1. Regulatory Updates on Korea [September 18th]
- Session 1. Regulatory Updates on US FDA or EMA [September 18th]
- Session 3. Use of Real World Evidence to Support Regulatory Decision Making [September 18th]
- Session 4. Challenges in Drug/Device Combination Products Trials (by MFDS) [September 18th]
- and many other sessions

Should you need any further information, please do not hesitate to contact us. (info-kic@konect.or.kr)