ICH Guideline Updates and Discussion: Q12, Q13 and Q2(R2)/Q14

ICH Q12 “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management” reached Step 4 during the last ICH meeting in Singapore in November 2019. Q5A(R2) “Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin” was endorsed by the ICH Assembly in June 2019 and EWG are advancing work on the concept paper. Q2(R2)/Q14 “Analytical Procedure Development and Revision of Q2(R1) Analytical Validation” and Q13 “Continuous Manufacturing of Drug Substances and Drug Products” are anticipated to sign-off on Step 1 in May and June 2020, respectively. This session will provide updates for these guidelines and concept papers through a series of discussions and case studies with industry and regulators to illustrate the mindset of the Expert Working Groups, before the next ICH meeting in Vancouver, BC, Canada in May 2020.