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Chungbuk C&V Center

Dec 05, 2018 8:00 AM - Dec 06, 2018 5:30 PM

Osong-eup, Osong-Saengmyeong-1-ro, 194 , Chungbuk, , Cheongju-si,  28160, Korea, Republic of

MFDS-DIA Workshop

Opportunities and Challenges in Drug Development and Approval

Session 2: Strategy for Biosimilar Development & Approval

Session Chair(s)

Hee Kyung  Kim, MBA, RPh

Hee Kyung Kim, MBA, RPh

Sr. Vice President

Samsung Bioepis, Korea, Republic of

Speaker(s)

SuEun  Song

Session 2.1 : Challenges in the Global Clinical Development of Biological Products

SuEun Song

CELLTRION, Korea, Republic of

Head of Clinical Operation

Se Eun  Kim, MPH, RN

Session 2.2 :Establishing Biosimilarity : Totality of Evidence

Se Eun Kim, MPH, RN

MFDS , Korea, Republic of

Director- Cell and Gene Therapy Products Division, NIFDS

HyeJung  Na

Session 2.3 : Global Regulatory Development Strategy of Biosimilar

HyeJung Na

Samsung Bioepis, Korea, Republic of

Director

Hae-Young  Ahn, PhD

Session 2.4 :Biosimilars: Current Status and Future Trends

Hae-Young Ahn, PhD

Ahn Bio, United States

President

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