7 November 2019
08:55 – 09:00 Start Summit, Gihwan Kim, Clupea, Inc CEQ, Host MC
09:00 – 09:05 Welcome Address, Seonghyup Lee, Director of DIP (Daegu Digital Industry Promotion Agency)
09:05 – 09:10 Welcome Address, Soondo Cha, M.D., Medicity Daegu Chairman
09:10 – 09:15 Welcome Address, Young-jin Kwon, Mayor of Daegu
09:15 – 09:20 Welcome Address, TBC, Member of the National Assembly
09:20 – 10:00 FDA Presentation, Dr. Ron Fitzmartin, FDA
10:00 – 10:30 State of the CDISC Union, David R. Bobbitt, CDISC President and CEO
10:30 – 11:00 Break
11:00 – 11:45 CDISC Foundational Standards Overview, Bess LeRoy, Head of Standards Development
11:45 – 12:45 Lunch
12:45 – 13:15 PMDA Presentation, Dr. Yuki Ando, PMDA
13:15 – 13:45 Therapeutic Area Standards and CDISC RWD (Real World Data) Connect, Rhonda Facile, Vice President, Development Opportunities
13:45 – 14:30 CDISC 360 and CDISC Library, Mike Hamidi, CDISC Head of Data Science
14:30 – 15:00 CDISC Coordinating Committees - Asia Pacific, China, Europe and Japan; CDISC Membership; Sheila Leaman, Vice President, Membership, Events & Asia Initiatives
15:00 – 15:45 Break
15:45 – 16:00 Special Lecture on Regulation, MFDS TBC
16:00 – 16:30 EMA Presentation, Dr. Frank Pétavy, EMA
16:30 – 16:45 CDISC for the Promotion of the Medical Big Data Industry, Jooyeon Kim, Manager of DIP
16:45 – 16:55 Probationary K3C Presentation, Dr. Im Hee Shin, Daegu Catholic University and Gihwan Kim, Clupea, Inc.
16:55 – 17:05 Closing