Harmonisation and application of BCS-based Guidance

Purpose of the Meeting

This symposium will look at the progress of the ICH M9 guidance (Biopharmaceutics Classification System (BCS)-Based Biowaivers) from a regulatory and industrial perspective; evaluating barriers to implementation from a solubility, permeability and dissolution perspective. Attendees will also better understand the progress that has been achieved by the International Pharmaceutical Federation (FIP) initiative on biowaiver monographs for essential drugs. These monographs are in-depth literature reviews, assessing whether a biowaiver can be recommended for a new formulation of an active pharmaceutical ingredient (API) based on publicly available data. It is also the intention of the meeting to seek feedback from JPAG members via a panel discussion, which in turn can be fed back to the ICH M9 Expert Working Group as part of the public consultation process. In addition, the symposium will look to update delegates on progress in the related fields of clinically relevant dissolution specifications and outcomes from the IMI OrBiTo consortium. 

Proposed outcomes

• Awareness of current requirements and future developments and challenges
• Opportunities to challenge / raise concerns and understand from experts in this field as to how they might be addressed
• Opportunities to provide their feedback into the ICH M9 process via an interactive panel discussion
• Hear from experts what is actually happening in practice and what the future state will look like.

Who should attend

This symposium should be attended by those involved in in vitro dissolution testing in R&D and production, in the compilation of regulatory dossiers and in the planning and execution of biowaivers in lieu of bioequivalence studies- particularly those working in consumer healthcare and developing markets. This symposium will also appeal to those working in CMOs and quality management.