This webinar presents a summary of current best practices and considerations for PBBM regulatory submissions generated by industrial and regulatory collaborators, with an eye towards decreasing deficiencies, reducing requests for additional information, and improving acceptance rates.
Sumit Arora will introduce the topic and its relevance in the current context where regulatory agencies and pharmaceutical companies have different levels of familiarity with PBBM elaboration and submission. Dr. Xavier Pepin will introduce the context, talk about model development/parameterization, selection of adequate formulation variants and clinical data. Dr. Arora will then cover themes around alignment of terminologies, credibility assessment framework, model validation and reuse, and will conclude the presentation.