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Conference

The Hi Korea conference programme offers you high-level sessions featuring opinion leaders from government and academia.

As a leading learning platform for trends and issues confronting the health ingredients & pharmaceutical industry in Korea and the region, the Hi Korea conference is an integral part of the event, and will give you a realistic assessment of the industry challenges, and strategies for dealing with them.

Hi Korea 2018 Conference Programme

Tuesday, August 22
 
◈ Session 1
Date Title Organisation Speaker
10:15 - 10:55 Experience of GMP Inspection at PMDA and Future Perspective of GMP in Japan PMDA YUKI KATOH,
Inspector
10:55 - 11:10 Break Time
11:10 - 11:50 Practical Examples with Q&A

* Japanese → Korean

◈ Session 2
Date Title Organisation Speaker
13:30 - 14:10 Claims for Foods in the European Union: Key Regulatory EAS
Strategies
Elodie Lebastard,
Manager Food Law
14:10 - 14:25 Break Time
14:25 - 15:05 Claims for Foods in the EU: Regulatory Checklist

* English → Korean

◈ Session 3
Date Title Organisation Speaker
15:30 - 16:30 WHO Prequalification Programme, Opportunities for Drug Product and API Manufacturers WHO
(World Health Organisation)
Dr. Antony Fake

* English → Korean

 
Wednesday, August 29
 
◈ Session 4
Date Title Organisation Speaker
10:15 - 10:55 The US Complex Generic Products & Biosimilar Product Regualtory Approval Process Insight, Advice & Solutions, LLC (USA) Dr. Ajaz S. Hussain
10:55 - 11:10 Break Time
11:10 - 11:50 US FDA Pre-approval and Routine cGMP Inspections for Complex Generic and Biosimialr Products

* English → Korean

◈ Session 5
Date Title Organisation Speaker
13:00 - 13:40 Recent Trends in the EU Market APIC Marieke van Dalen,
Global Regulatory Specialist
13:40 - 13:55 Break Time
13:55 - 14:35 Implementation of ICH Q3D (elemental impurities) for APIs - Practical examples

* English → Korean

◈ Session 6
Date Title Organisation Speaker
15:00 - 15:40 The Biologics Drug Development in China - CMC and Quality Challenges 1 Suzhou AABioQ Pharmaceuticals Co., Ltd. (China) Dr. Clsaudia Lin,
CEO
15:40 - 15:55 Break Time
15:55 - 16:35 The Biologics Drug Development in China - CMC and Quality Challenges 2

* English → Korean

 
Thursday, August 30
 
◈ Session 7
Date Title Organisation Speaker
10:15 - 10:55 중국 내 건강기능식품 인증 관련 규정 및 해당 규정이 소비자에게 미치는 영향 China Skinny Andrew Atkinson,
Marketing Manager
10:55 -11:10 Break Time
11:10 - 11:50 중국 건강식품 시장 현황 및 트렌드

* English → Korean

◈ Session 8
Date Title Organisation Speaker
13:00 - 13:40 Changes in ICH E6 GCP(R2) and Issues Concerning Safety Evaluation and Reporting of Clinical Trials MEDI-INSIGHT Corp Tae Gyun Nam,
CEO
13:40 - 13:55 Break Time    
13:55 - 14:35 Current Trend in Pharmaceutical GMP Policy MFDS(Ministry of Food and Drug Safety) JeongHyun Choi,
Assistant Deputy Director

* Korean only

※ Please note that the above timetable is subject to change without prior
    notice by the organiser or speakers.

Conference Registration Speakers Free Seminar