Thursday, 20th January 2022
14:00 |
ICH E8 (R1) FINAL Guideline on General Considerations for Clinical Studies
|
14:00 |
Welcome and Introduction to the Tutor
Sanjay Bajaj, CEO & MD, Glostem Private Limited, India
|
14:05 |
Technical Session 1
Liz Wool, President & CEO, Wool Consulting Group, USA
1. Describe the General Principles in ICH E8 (R1)
2. Discuss designing QUALTY into clinical trials
3. Explain drug development planning |
15:30 |
Break
|
15:40 |
Technical Session II
Liz Wool, President & CEO, Wool Consulting Group, USA
4. Identify clinical study design elements and data sources for clinical studies
5. Assess trial execution activities that includes study conduct, participant safety and study reporting
6. Interpret considerations in identifying critical to quality factors |
17:00 |
Q/A Session
|
17:30 |
Closing of Day 1
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Friday, 21st January 2022
14:00 |
International Conference for Harmonisation (ICH) E6 Good Clinical Practice (GCP) Pending Revision 3 in 2022
|
14:05 |
Technical Session I
Liz Wool, President & CEO, Wool Consulting Group, USA
1. Describe the reasons for a third revision (R3) to ICH E6 GCP
2. Discuss the overarching principles document added to ICH E6 GCP (R3) |
15:30 |
Break
|
15:40 |
Technical Session II
Liz Wool, President & CEO, Wool Consulting Group, USA
3. Explain the new ANNEXEs that are added to ICH E6 E6 GCP (R3) |
17:00 |
Q/A Session
|
17:25 |
Closing Remarks
Sanjay Bajaj, CEO & MD, Glostem Private Limited, India
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