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GMPs in Early Development Webinar

GMPs in Early Development Webinar

September 28, 2012


A key challenge for the Pharmaceutical industry in the coming years is to drive innovations in science, technology, and business practices to improve R&D productivity in bringing new medicines to patients. Towards this end, in early 2011, the IQ consortium’s Analytical and Drug Product Leadership Groups formed a joint Working Group (WG) to consider opportunities for improving efficiency in Early Development. This presentation will describe the efforts of the GMPs in Early Development Working Group. The rationale for this WG is that while the concept of “phase-appropriate GMPs” is fairly well known, most regulatory guidance and the efforts of ICH focus on late-stage development (Phase 3 and beyond). The WG believes that improved clarity in definition of GMP expectations for early development (Phase I to 2a) would advance innovation in drug product development with the potential to improve cycle times and reduce costs, while maintaining appropriate product quality and ensuring patient safety.

The presentation will describe the scope, key objectives and the activities of the WG over the past 12 to 18 months. The WG’s focus has been to develop a series of position papers where it was felt additional clarity in GMP expectations would add value. The papers represent industry positions on best practices in four areas: Analytical methods, Specifications, Drug Product Manufacturing and Stability. The intention of the papers is to stimulate discussion and build alignment with internal stakeholders and regulatory agencies. In addition, the papers set the stage for further discussion in the form of a joint workshop. The presentation will conclude with a brief description of the workshop which is in the early phases of planning and anticipated to occur in mid-2013.

This webinar will be from 11:00AM-12:00PM ET. It is open to members of all IQ Consortium committees.