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

2019 Conference Agenda

 

This information will be updated shortly.

Last Conference Agenda (2018)

지난 컨퍼런스 일정 (2018)
8.28(Tue) Time Title Organisation Speaker
Session 1 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
Session 2 13:30 - 14:10 Claims for Foods in the European Union: Key Regulatory Features 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
Session 3 15:30 - 16:30 WHO Prequalification Programme, Opportunities for Drug Product and API Manufacturers WHO
(World Health Organisation)
Dr. Antony Fake

지난 컨퍼런스 일정 (2018)
8.29(Wed) Time Title Organisation Speaker
Session 4 10:15 - 10:55 The US Complex Generic Products & Biosimilar Product Regulatory 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 Biosimilar Products.
Session 5 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
Session 6 15:00 - 15:40 The Biologics Drug Development in China - CMC and Quality Challenges 1 Suzhou AABioQ Pharmaceuticals Co., Ltd. (China) Dr. Claudia Lin,
15:40 - 15:55 Break Time    
15:55 - 16:35 The Biologics Drug Development in China - CMC and Quality Challenges 2   CEO

지난 컨퍼런스 일정 (2018)
8.30(Thu) Time Title Organisation Speaker
Session 7 10:15 - 10:55 Nutrition and Health Food Claim Regulations in China & What They Mean to Consumers China Skinny Andrew Atkinson, Marketing Manager
10:55 - 11:10 Break Time
11:10 - 11:50 Trends Impacting the Health Food Market in China
Session 8 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