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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 4: Regulatory and Industry Perspectives in Clinical Development

Session Chair(s)

Jung Yun  Chang

Jung Yun Chang

Pharmaceutical Standardization Division

Ministry of Food and Drug Safety (MFDS), Korea, Republic of

Session 4.1 : cGMP Inspection cases-common findings

Speaker(s)

Charles  Ahn

Session 4.1 : cGMP Inspection Cases-Common Findings/ Responses in Asia

Charles Ahn

Aegisbeacon, Korea, Republic of

Principal Consultant

Sun Jin  Kim

Session 4.2 :Differentiation Strategy for the Drugs Preclinical Development Using Orthotropic Animal Models

Sun Jin Kim

Platbio Inc., Korea, Republic of

Chairman/Founder

Hae-Young  Ahn, PhD

Session 4.3 :Enhanced Early Clinical Drug Development with Advanced Tools

Hae-Young Ahn, PhD

Ahn Bio, United States

President

Mee Ryung  Ahn, PhD

Session 4.4 :Clinical Multi-Regional Clinical Trial in Korea

Mee Ryung Ahn, PhD

Ministry of Food and Drug Safety, Korea, Republic of

Director

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