The final ICH Q12 Guideline "Product Life Cycle Management" is currently in the implementation phase in the ICH regions. Regulators and Industry expect more regulatory flexibility for the management of post-approval changes by using the tools provided in ICH Q12, e.g. "Established Conditions" (ECs) and the "Post approval Change Management Protocol" (PACMP).
During the implementation phase the U.S. FDA started an Established Conditions Pilot. At ECA's Live Online Conference ICH Q12 Product Life Cycle Management from 15-16 September 2020 case studies (for process and product) from the pilot will be presented by FDA Speakers!
These concepts (e.g. Established Conditions) also apply to analytical methods. The new ICH Q14 Guideline on analytical procedure development is expected to build a bridge between ICH Q12 and ICH Q2 (R1) on analytical method validation. Therefore, the ICHQ2/14 Analytical Procedure Life Cycle Management Online Conference takes place directly after the ICH Q12 Conference on 16 and 17 September.