| Session 1. Regulatory Update |
|
Korea Food and Drug Administration (KFDA) continuously improves its regulations and guideline to secure the efficacy and safety of drug products. Recent enforcement of the validation requirement is evaluated as a essential step to prepare Korea-US FTA and to export the drug products to advanced countries. Therefore, it is very important to update recent development in the KFDA regulations. In this session a plan of KFDA for CTD (Common Technical Document) which ICH had implemented in its State Parties, Global GMP training, and regulations of cell bank control and validation for biologics manufacturing. |
| Chair : Chan Wha KIM, Professor, Korea Univ. |
 |
- Efficient and Practical Training Program for Vaccine Manufacturer
and National Regulatory Authority Personnel |
| Chung Keel LEE, Special Advisor/Adjunct Professor, Biopharmaceutical Bureau, Korea Food & Drug Administration/Life Sciences & Biotechnology, Korea Univ. |
|
   |
|
- Implementation of the Common Technical Document (CTD) in Korea
: Biotechnological/Biological Products |
| Sookyung SUH, Senior Scientific Officer, Recombinant Products Division, Korea Food & Drug Administration |
|
|
|
- Safety Evaluation and Validation of Cell Substrates and Managing
Contamination for Production of High Quality Biotechnological
Products such as Biopharmaceuticals
: Current Trends in Cell Banking Technologies |
| Sue Nie PARK, Director, NITR, Division of Genetic Toxicology, Korea Food & Drug Administration |
|
|
|
|
| Session 2. GMP Compliance |
|
GMP compliance is one of the most important tasks in the drug manufacturing. Therefore, drug manufacturing companies allocate significant portions of their resources to improve levels of GMP. In this session industrial experts will present PAT in manufacturing processes and quality control in biopharmaceutical manufacturing. In addition, GMP compliance in research institute will be presented. |
| Chair : Doo Hong PARK, Director, Green Cross Corp., Korea |
|
| - Validation of Sterile Filtration Systems |
| Chan-Wha KIM, Professor, Division of Life Sciences & Biotech., Korea Univ. |
|
|
|
| - GMP-compliant Testing of Biopharmaceuticals |
| Guy BERG, Senior Vice President, Business Development, NewLab BioQuality AG |
|
 |
|
- GMP Application in Research & Development Institute
: Quality Management in Research & Development Phase |
| Do Yeon LEE, Manager, CJ CheilJedang Corp. Pharmaceutical Bureau R&D QA |
|
|
|
|
| Session 3. Quality Control and Quality Assurance |
|
| With rapid growth of the monoclonal antibody therapeutic market, technological demand of quality control and quality assurance of therapeutic monoclonal antibody manufacturing increases. In this session, validation of analytical method and quality assurance for monoclonal antibodies will be presented by industrial experts. In addition, quality assurance in vaccine manufacturing will be presented. |
Chair : Gyun Min LEE, Professor, Korea Advanced Institute of Science and Tech. |
|
| - Validation of Analytical Method for Monoclonal Antibody Products |
| KC CHENG, Associate Director, Analytical and Formulation Development, Medarex Inc. |
|
|
|
| - Quality Assurance of Monoclonal Antibody Manufacturing Processes |
| Brian KIM, Vice President, QA & Regulatory Compliance, Celltrion Inc. |
|
|
|
| - Continuous Improvement and Modern Quality System |
| Sang Jeom AHN, CEO/President, Berna Biotech Korea Corp. |
|
|
|
|
|
