Anja Slikkerveer, MD, PhD, ERT
Genotoxic Impurities in
GTI strategies & new methodologies: analysis, in silico & regulations. Challenges & opportunities.
Pharmaceuticals Summit 2019
- 11 Apr 2019
- Berlin, DE
Day 1: Thursday, 11 April 2019
CASE STUDY: ICH Q3D: elemental impurities- an insider’s perspective.
- How did the ICH process work for this quality guideline with a large safety component?
- How were the elements covered in the guideline selected?
- How was relevant literature selected?
- Do the PDE cover pediatric products?
- Can the PDE be exceeded?