FDA-Duke Global Regulatory Pre-Workshop

White Flint Amphitheater

Date: Tuesday, May 7, 2019

8:00 – 8:30 AM
Registration/Continental Breakfast
8:30 – 8:35 am
Welcome/Introduction/Goals of the Workshop
Speaker
Ke LiuUS FDA
8:35 – 10:05 am
Moderator
Session I: International Regulators’ Forum
Agnes ChanSingapore HSA
Larissa HigginsEMA Representative
Jaigi MathaiHealth Canada
Jan Mueller-BerghausGermany PEI
Sumimasa NagaiJapan PMDA
Kelly NorsworthyUS FDA
Ho Jung OhKorea MFDS
Anuradha PoonepalliSingapore HSA
S. Eswara ReddyIndia CDSCO
Arun SinghalGovernment of India
Joohee SulUS FDA
Reiko YanagiharaJapan PMDA
Hong ZhangChina NMPA
Ming ZhouChina NMPA
10:05 – 10:30 am
Break
10:30 – 11:45 pm
Moderator
Session II: Academic Investigators’ Perspectives
Panelists
Xiaoyuan ChenTsinghua University
Thomas GrossNational Cancer Institute
Abiola IbraheemUniversity of Chicago

Funmi Olopade

University of Chicago
Jun RenChina Capital Medical University
Martin StocklerThe University of Sydney
11:45 – 12:45 pm
Lunch
12:45 – 2:05 pm
Moderator
Session III: Oncology Drug Development and Approval in China
Panelists
Tao FuZai Laboratory
Xiaoyuan ChenTsinghua University
Frank JiangCStone
Jian PengShenogen Pharma Group
Dan ZhangFountain Medicine
2:05 – 2:25 pm
Break
2:25 – 3:45 pm
Moderator

Joseph Arena, Pfizer

Session IV: Industry’s View on Global Drug Development
Panelists
3:45 – 4:45 pm
Moderator

Kate Rawson, Prevision Policy

Session V: What Media Say about Global Drug Development
Panelists
Joshua BerlinBiocentury
Nielsen HobbsThe Pink Sheet
Sarah Karlin-SmithPolitico
Steve UsdinBiocentury
Craig TendlerJanssen
4:45 – 4:50 pm
Closing Remarks
Speaker
Ke LiuUS FDA
4:50 pm
Adjourn
5:00 - 6:00 pm
Networking Reception in Brookside A and B