Biosimilars Workshop

Start Date & Time: 
Tuesday, 30 August, 2016 - 08:30
End Date & Time: 
Friday, 2 September, 2016 - 18:00
Venue: 

Lead on 3, Room #03-16
Duke-NUS Medical School

Speaker: 
Speaker Details: 

Dr Yasuhiro Kishioka
Principal Reviewer,
Office of Cellular and Tissue-based Products, 
PMDA

Speaker: 
Speaker Details: 

Dr Kenji Sawanobori
Reviewer,
Office of Cellular and Tissue-based Products,
PMDA
For the full list of speakers, click here.

Synopsis: 

Through this workshop, our aim is to build skilled human capacity in regulatory science to promote and facilitate the accessibility of biosimilars, through quality submissions and effective evaluations, and to enhance regulatory cooperation on regulation of biosimilars. 

Biography: 

Dr Kishioka is a principal reviewer in the Office of Cellular and Tissue-based Products of the Japanese regulatory agency, Pharmaceuticals and Medical Devices Agency (PMDA). Since joining PMDA in 2008, his main work is the pharmaceutical quality review of biotechnological/biological products. His areas of expertise also include biosimilars and he has been assigned as the ICH Q12 topic leader of Japanese regulatory authorities. He holds a Ph.D from Hokkaido University in Meat Science with emphasis in Molecular Biology. 

Dr Sawanobori, a pharmacist, has been a reviewer at the Office of Cellular and Tissue-based Products at Pharmaceuticals and Medical Devices Agency (PMDA) in Japan since 2010. He is currently a team leader for CMC of biologics and biosimilar products review team, where CMC, non-clinical, clinical evaluations of the biosimilar products are conducted. He actively participates in various PMDA, IPRF, and WHO working groups and expert committees on biologics.

Dr.Sawanobori has received his Ph.D in pharmaceutical science from the Tokyo University, Japan in 2010.

Host: 

A/Prof John Lim 
Executive Director, CoRE, 
Duke-NUS & Deputy Director of Medical Services (Industry & Research Matters), 
Ministry of Health, Singapore 

Other Information: 

10% discount for groups of 5 or more
10% discount for "CoRE Contributors"
All prices are inclusive of GST.
All prices in SGD.

Contact Person: 

Sherna Wadia, sherna.wadia@duke-nus.edu.sg