Quantitative Systems Pharmacology (QSP) is increasingly applied in MIDD frameworks and regulatory interactions, though challenges remain in ensuring transparency and credibility. This webinar will share insights from the group’s work, including considerations on virtual populations, regulatory submission examples, proposed minimum evaluation criteria, and ongoing challenges highlighting areas in need of further regulatory guidance.
The presentation will be given by ISoP QSP SIG WG on Credibility Assessment of QSP for regulatory use. The ISoP QSP SIG Working Group on Credibility Assessment of QSP for regulatory use was launched in fall of 2024 with multiple members from the QSP community. The Working Group has a charter focused on: i)identification and systematic evaluation of typical regulatory context of use scenarios for QSP based on community experiences and published examples, ii) evaluation and formulation of best practices for credibility assessment and reporting of QSP in regulatory settings, iii) engagement of the community via outreach to develop a shared vision for QSP credibility assessment standards based on existing case studies and future areas of growth for QSP.
The MIDD Webinar Series, coordinated by Yash Kapoor and Fulya Akpinar Singh, is a series of webinars focused on shaping the future of drug development and regulatory decision-making sponsored by the ISoP Education Committee. Topics range from MIDD approaches in regulatory submission to pharmacometrics topics that are at the core of model development.