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제6회 품질규제과학 국제 웨비나 컨퍼런스
혁신기술 기반 의약품 개발 및 품질보증
Development and Quality Assurance of Innovative Manufacturing Technology-based Pharmaceuticals
2021년 11월 2일 화요일 ZOOM Webinar
Webinar’s Agenda (Tentative)
This webinar is aimed to understand and promote development and quality assurance of innovative manufacturing technology (IMT)-based pharmaceuticals, by applying continuous manufacturing (CM, ICH Q13) technologies in pharmaceutical company. Webinar conference will be composed of three sessions and panel discussion.
1. Session I: Current regulatory considerations and challenges for IMT in Korea
- Policy-level support for application of IMT including CM to pharmaceuticals
- International regulatory status of IMT including CM
- Regulatory status of quality by design and PAT
2. Session II: Current status and challenges of CM in Japan
- Regulatory considerations (including approval review) and challenges
- Techniques for manufacturing and quality controls, and RTRT
- Industrial status in PAT, process system technologies and models
3. Session III: Promoting and realizing CM in pharma industry
- Governmental support and results for IMT in Korea
- Understanding and perspectives of CM in the viewpoint of ICH Q13
- Case study of PAT application in pharma industry
- Change control from batch production to CM
- Chemometrics and statistical tools
4. Panel discussion on CM in English
Six panelists (three speakers each from Japan and Korea) will discuss about challenges from regulatory, quality and technology aspects, each for five minutes, and related answers or comments among panelists will be given in real-time for 50 minutes.
Please understand that suggested agenda may be changed, depending on the request from speakers or moderator, and emerging topic.