Anja Slikkerveer, MD, PhD, ERT, Astellas Pharma Europe BV - Qepler Summits And Conferences

Anja Slikkerveer, MD, PhD, ERT

Scientific Director Translational Science
Astellas Pharma Europe BV
Hague, Netherlands
Astellas Pharma EMEA

Related Sessions:

Genotoxic Impurities in
Pharmaceuticals Summit 2019

GTI strategies & new methodologies: analysis, in silico & regulations. Challenges & opportunities.
  • 11 Apr 2019
  • Berlin, DE
  • Pharma
Day 1: Thursday, 11 April 2019
BLOCK:
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?
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