Module 3 Presentations

07/05/2024

Investigational Products

• Annex 13 (CTD) or detailed Commission guidelines No C(2017) 8179 on GMP for investigational medicinal products for human use (CTR) • Includes specifics to Clinical Trial Materials

• Auxiliary Medicinal Products & Comparators

Blinding

•

• Labelling for clinical trial material

Product Specification Files

•

• Randomisation and Randomisation Code

• Specific considerations for Clinical Trial Materials in line with the other chapters in Eudralex

The Organisation for Professionals in Regulatory Affairs

11

Eudralex-volume-10

The Organisation for Professionals in Regulatory Affairs

12

6