Module 3 - Strategic case studies in practice

Identifying the guidelines that apply ICH: https://www.ich.org/page/quality-guidelines EMA: https://www.ema.europa.eu/en/human-regulatory/research- development/scientific-guidelines/quality-guidelines Medical devices MDCG https://ec.europa.eu/health/md_sector/new_regulations/guidance_en

FDA:

• https://www.fda.gov/drugs/pharmaceutical-quality-resources/guidances-and- manuals-pharmaceutical-quality