Regulatory

Back to Forum

This forum has 17 topics, 50 replies, and was last updated 1 week, 1 day ago by Nikoletta Toth.

Viewing 15 topics - 1 through 15 (of 17 total)

- Topics
- Replies
- Author
- Site-to-Site IMP Transfer in the EU
- 1
- By Nikoletta Toth
- CE-marked requirements for product to be used clinical investigation
- 1
- By Anonymous
- Out of country sourcing
- 2
- By Anonymous
- Package Insert
- 2
- By Anonymous
- Grace period for label changes
- 9
- By Anonymous
- Seeking examples of finished product release documents
- 3
- By Anonymous
- EU guideline on shipping and temp monitoring (536/2014)
- 8
- By Josh Anderson
- Regulatory release of IMP
- 6
- By Amy Thompson
- Comparator references in INDs
- 2
- By Anonymous
- IMP Accountability in IRT & Returns/Destruction @ site
- 7
- By Marla Cordova
- Virtual Finished CT Material Retention Samples
- 3
- By Anonymous
- Minimum Shelf Life Requirements for Importation to Asia-Pac
- 2
- By Anonymous
- Keeping Up With Changing Regulations
- 5
- By Anonymous
- COA vs COC
- 2
- By Anonymous
- New GCSG Global Regulatory Team
- 8
- By Philippe Van der Hofstadt

Viewing 15 topics - 1 through 15 (of 17 total)

You must be logged in to create new topics.

Become a member

Global Clinical Supplies Group

Join GCSG for full access...

to our educational resources, conference materials and our directory of more than 480 Clinical Supply colleagues. Experience the culture of collaboration, It only takes approximately 3 minutes 22 seconds.

Please note that membership is included and FREE of charge when you sign up for an event.

Join Renew