SELECT * FROM sessions where years='2017' and sequence=128
December 3-7, 2018 at Atlantic City, New Jersey
The 74th Deming Conference on Applied Statistics
Sponsored by Metropolitan Section, ASQ and Biopharmaceutical Section, ASA

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Roles of Biostatisticians In New Drug Development and Regulatory Review

Speaker(s): Dr. Yuki Ando, Senior Scientist for Biostatistics
Pharmaceuticals and Medical Devices Agency, Japan
Moderator: Naitee Ting

Dr. Yuki Ando is a Senior Scientist for Biostatistics of the Pharmaceuticals and Medical Devices Agency (PMDA), Japan.

She received a masterís degree in Engineering from Tokyo Science University, and PhD in Health Science from Osaka University.

In 1997, she joined the Pharmaceuticals and Medical Devices Evaluation Center (PMDEC), which was established that year and subsequently transformed into the current PMDA. Currently she is responsible for the biostatistics review and consultation in the new drug and device review offices in PMDA. Additionally, she works as a leader of business part of Advanced Review with Electronic Data Promotion Group, the group which is responsible for the use of patient level electronic study data that are submitted with new drug applications in Japan. She is responsible for promoting CDISC implementation and the use of submitted electronic data in new drug review in PMDA.

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