In the first quarter of 2022 drafts of ICH Q2(R2) and Q14 were released for public comment. This is the first time there have been significant changes to the guidance for analytical methods since the release of Q2 in the 1990's. Stop and think for a moment how much change there has been in the past several decades. The speed of development has increased, the diversity of therapeutic products has changed, and the technology employed (including use of multivariate methods) to test these materials has continued to evolve.
This session will bring together the opinions of thought leaders in this area (EWG industry, EWG regulatory, and the practitioner) to share their perspectives and lead a discussion on the new operating system that is possible given the new draft ICH guidelines.
Presentations will be followed by a roundtable/panel discussion to address questions and obtain feedback on the guidance documents (including implementation and case studies) and/or solicit input on any available feedback from the EWG.
Executive Director Synthetic Molecule Design & Development,
Eli LIlly & Company