Module 3 - Strategic case studies in practice
Implementation Working Group ICH Q11 Guideline: DEVELOPMENT AND MANUFACTURE OF DRUG SUBSTANCES (CHEMICAL ENTITIES AND BIOTECHNOLOGICAL/BIOLOGICAL ENTITIES) Questions and Answers
Version: 23 August 2017
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ICH Secretariat, Chemin des Mines 9, 1202 Geneva, Switzerland Telephone: +41 (22) 338 32 06 - admin@ich.org, http://www.ich.org
Made with FlippingBook Learn more on our blog