Application
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- KIC_eng.
[KoNECT-APEC] MRCT & GCP INSPECTION
| Classification | Mixed education | ||
|---|---|---|---|
| Category | KIC_eng. > Level 6 | ||
| Name | [KoNECT-APEC] MRCT & GCP INSPECTION | ||
| Application period | 2024.07.01 (09:00) ~ 2024.10.25 (24:00) | Education period | 2024.10.30 ~ 2024.10.30 |
| Days/hour | 1 days / 6 hours | Place |
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| Education fee | free | Capacity | 610people |
- Introduction
- Table of contents
- Education schedule
Poster
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Program
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*Program subject to change without notice *Simultaneous Interpretation Provided | |||
| Chaired by : Sumi Hyun(Qvis), Seunghoon Han(The Catholic Univ) | |||
| Topic | Speaker | Affiliation | |
| Opening Remarks | KoNECT | ||
| Lecture 1 | 1.U.S. FDA’s Good Clinical Practice Assessment and Review for Marketing Applications | Ling Yang | FDA |
| Lecture 2 | 2. (MFDS) What regulators/inspectors expect in GCP inspection and current trends based on actual experiences +Evaluation of Inspection findings | Park, KyeongSoo | Medi-Insight |
| Lecture 3 | 3. (EMA) Draft ICH E6 (R3) Guideline - Regulatory perspective | Dong Ho Kim Pietsch | EMA |
| Lunch | |||
| Lecture 4 | 4. Putting principles into Practice: Implementing the updated ICH E6 R3 | Ernesto Vera-Sanchez | Allucent |
| Lecture 5 | 5. Considerations on the multi-regional decentralized trials | Seunghoon Han | ?the Catholic Univ. of Korea |
| Lecture 6 | 6. Intelligent Multi-Regional Clinical Trials (MRCT) strategy | Hyun Hee Na | LSK GLOBAL PS |
| Break | |||
| Panel Discussion | |||
| Closing | |||
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Information
Thank you for your interest in participating in our workshop.
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Please refer to the attached agenda for details about the program and the instructor.
The workshop will be conducted in a webinar format.
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Registration for the workshop is on a first-come, first-served basis, and may close early. After registering on the KoNECT website, you can apply for the course, and a certificate of completion will be issued in 1~2 week after completion of survey.
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We sincerely appreciate your interest in this workshop.
If you have any questions, please contact us at global@konect.or.kr or the administrative office at 070-4711-7762.
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Thank you.
Pass/fail criteria
| Evaluation criteria | Attendance rate | Online progress rate | Test | Task | Discussion | Others |
|---|---|---|---|---|---|---|
| Percentage in evaluation | 100.00% | - | - | - | - | - |
| Minimum requirement | - | - | - | - | - | - |
KAC, 6th floor of the 137 KPX Building, Mapo-daero, Mapo-gu, Seoul, Republic of Korea / Business Registration Number: 110-82-17935 / Director: Inseok Park
Education 02-398-5090, 02-398-5036, 02-398-5093, 02-398-5094
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