2021 Program

Program Details

October 05 (Tue)

Time Program Speaker Affilliation
09:00~09:30 Registration
W1: NIFDS-KoNECT Multi-Regional Clinical Trials and GCP Inspection Workshop
09:30~11:00 Multi-Regional Clinical Trials: Expediting Global Clinical Development for Patients Chair : HyunJoo Rhee,
Paul (Neunggyu) Park
09:30~10:00 How to Design a Successful MRCT with a Focus on Neurodegeneration Joanne Bell Syneos Health
10:00~10:25 Key Consideration to Conduct MRCTs Saumya Nayak IQVIA
10:25~10:50 Case Study (Strategic Perspective) Romi Singh Pfizer
10:50~11:00 Q&A All Chairs & Speakers -
11:00~11:30 Coffee Break
11:30~13:00 GCP Inspection (TBD) Chair : Sumi Hyun,
Jung-Ah Byun
11:30~11:50 PV Inspection Trend Jung-Ah Byun MFDS
11:50~12:20 Remote Insepction Experiences Eunjung Choi Seqirus
12:20~12:50 Inspection Readiness on New Digital Technology TBD TBD
12:50~13:00 Q&A All Chairs & Speakers -
W2: Flawless IND Preparedness
09:30~11:00 Preparation of U.S. IND Chair : Tae Youn Jo,
Jeong Weon Park
09:30~10:00 CMC documentation for IND Jun Park ILIAS Biologics
10:00~10:25 Key to Submit a Successful IND application to the FDA Kathryn Penhale-Unz IQVIA
10:25~10:50 Regulatory Strategy and Practical aspect of Pre-IND meeting with FDA Yeonhee Ahn ImmuneOncia Therapeutics Inc
10:50~11:00 Q&A All Chairs & Speakers -
11:00~11:30 Coffee Break
11:30~13:00 Regulatory Interaction Chair : Jina Jung,
Jeong-Ja Oh
11:30~13:00 FDA environment for Oncology Drug Development Zohra Lomri Syneos Health
12:10~12:50 Communication Between IND Sponsors and Regulatory Agency during Drug Development Yun Joo Kim Yuhan Corporation
12:50~13:00 Q&A All Chairs & Speakers -
13:00~14:00 Lunch Break
W3: Practical Approaches to Global Trials (for K-Bio)
14:00~15:30 Preparing a Global Clinical Trial Chair : Yukyung Kwon,
Kyounghee Seo
14:00~14:40 How To Optimize CRO & Clinical Trial Site Selection Process in Global Trials Kyounghee Seo GemVax Pharmaceutical
14:40~15:20 Challenges and Opportunities for Conducting Global Trials in the COVID-19 Era Stephen Lutsch LEO Pharma
15:20~15:30 Q&A All Chairs & Speakers -
15:30~16:00 Coffee Break
16:00~17:30 Practices for Global Clinical Trial Operation Chair : Byung-In Yoon,
Saeyun Baik
16:00~16:30 Key Strategies for the Effective Study Initiation in Global Trials Mike Park C&R Research
16:30~16:50 Management of Clinical Supply in Global Trials Michelle Lynskey ICON plc
16:50~17:20 Trend Updates in Global Audit, Inspections and Findings Jiyeon Lee Hanmi Pharmaceuticals
17:20~17:30 Q&A All Chairs & Speakers -
W4 : Business Development and Partnering
14:00~15:30 BD Overview and Deals of 2020/21 Chair : James Lee,
Sung-Chun Kim
14:00~14:40 BD Overview and Korea 2021 Snapshot/Trends Sung-Chun Kim Olipass
14:40~15:20 Trends in Partnering Deals 2020-2021 (TBD) Soomin Shim Partners Investment
15:20~15:30 Q&A All Chairs & Speakers -
15:30~16:00 Coffee Break
16:00~17:30 Alliance Management Chair : Sung-Chun Kim,
Seungwon Jeong
16:00~16:40 HanAll - Roivant from 2017 to 2021 Seungwon Jeong HanAll Biopharma
16:40~17:20 The Beginning of Global Cooperation and Its Endless Challenges Lauren Young-Mi Lee Hanmi Pharmaceuticals
17:20~17:30 Q&A All Chairs & Speakers -

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