This session will explore the critical role of Identification of Medicinal Products (IDMP) standards in addressing global healthcare challenges, such as pharmacovigilance, drug shortages, and medicinal product traceability.
Learning Objectives
Discuss how IDMP standards address drug shortages by enhancing supply chain transparency and traceability; Identify the challenges and opportunities in implementing IDMP globally, focusing on the need for regulatory collaboration and interoperability; Explain the significance of global identifiers, such as PhPID, in ensuring consistent product identification across regions.
Senior Advisor, Office of Regulatory Operations, CBER, FDA, United States
Ron Fitzmartin is a Senior Advisor in the Data Standards Branch, Office of Regulatory Operations, Center for Biologics Evaluation and Research, FDA. He provides policy and strategy consultation on electronic regulatory submissions and standardized data. Ron serves as Rapporteur for... Read More →
Monday June 16, 2025 11:00am - 12:00pm EDT
TBDWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
Discover how to redesign R&D policies with women in mind. Join experts to explore why women’s inclusion in clinical trials matters, what changes are needed, and how stakeholders can drive impact. Together, let's shape a more inclusive future for research.
Learning Objectives
Evaluate the historical underrepresentation of women in clinical trials, its healthcare impact, and the role of initiatives like the FDA's Diversity Action Plan in addressing gender disparities; Identify key policy changes and strategies for including gender considerations into clinical trial design; Develop actionable approaches to foster cross-sector collaboration among industry, regulatory bodies, government, and research institutions to advance gender diversity in clinical research.
Experts representing industry, non-profit, research, regulatory, and payor perspectives will explore key hurdles and solutions to rare disease treatment development, from recruitment and diagnosis to late-stage development and access after accelerated approval.
Learning Objectives
Identify hurdles and solutions to clinical trial recruitment, incl. early diagnosis and newborn screening; Explore approaches to patient stratification, disease understanding, and novel biomarkers, while de-risking late-stage development in competitive and high-failure landscapes; Examine challenges of market access and pricing after accelerated approval, and gain insights into addressing payer-specific concerns to ensure equitable access.
Wednesday June 18, 2025 8:30am - 9:30am EDT
TBDWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
