Pharmaceutical manufacturers are exploring how the ICH Q12 lifecycle management concepts can be implemented internally and in their interactions with regulators to maximize the benefits in practice.
ICH’s Expert Working Group (EWG) members, in turn, are encouraging industry to share its experience with the group on where the implementation challenges lie and how the draft guideline can be refined to help address them.
The EWG is also interested in hearing from industry on the implementation strategies that are proving effective, so that they can be shared back more broadly as part of the training effort that the group recognizes as essential to realizing Q12’s value.
The CASSS WCBP conference, held in Washington, DC January 30-February 1 is among the recent venues that have provided a substantive opportunity for EWG members to meet with their industry and regulatory colleagues and explore the Q12 concepts, what they are trying to achieve, and the challenges and opportunities that present themselves on the implementation pathway.
A dozen of the key players in the guideline development efforts, including nine EWG members, participated in the dialogue at a session of the conference specifically focused on Q12. At the session, they had the opportunity to share insights on the guideline’s intent, significance, and implementation, and where the feedback on the draft would be most helpful.