Regulatory

Back to Forum

This forum has 23 topics, 49 replies, and was last updated 1 month, 2 weeks ago by Anonymous.

Viewing 15 topics - 1 through 15 (of 23 total)

- Topics
- Replies
- Author
- Out of country sourcing
- 1
- By Anonymous
- # of Samples Required after transition to CTR
- 1
- By Anonymous
- Clarification on IMP Batches Transitioning from CTD to CTR
- 1
- By Anonymous
- Package Insert
- 2
- By Anonymous
- Acceptable Testing Methods for Health Canada Canadian Trials
- 1
- 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
- Annex VI labelling requirements EU/EMA public consultation
- 1
- By Shawn Murtough
- Regulatory – FDA/EMA approval screening
- 1
- By admin@mygcsg.com
- Minimum Shelf Life Requirements for Importation to Asia-Pac
- 2
- By Anonymous

Viewing 15 topics - 1 through 15 (of 23 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