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In response to the competitive landscape, unmet medical needs and increased patient demand, pharmaceutical companies have taken phase appropriate GMP approaches to accelerate drug development to market. In addition, increased interactions between regulatory agencies and industry also allowed for clarity and acceptability of these expedited approaches. This session focuses on industry and regulatory perspectives of phase appropriate GMP considerations for process and analytical development and validation, including considerations for different modalities (e.g. antibody-drug conjugates, vaccines, cell/gene therapies). Furthermore, the session will also cover innovative approaches such as setting of phase appropriate specifications, use of pools of clones for toxicological studies, clearance of process- and product-related impurities, phase appropriate raw materials testing, and inspection and commercial readiness.
A review of the regulatory requirements and guidance recommendations to support storage conditions of reconstituted and/or diluted drug products during IND development and for BLA approval will be presented. Microbial challenge study design and data analysis will be discussed…
In response to increasing demands to expedite the availability of various therapeutic modalities globally, health authorities have developed accelerated regulatory pathways to reduce development timelines towards product licensure with the goal of patient benefit…
Innovative regulatory pathways have accelerated product development and approval for many innovative medicines for patients with an unmet medical need. These pathways have broken down barriers to speed up access for new therapies and have had a direct impact on public health…