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Advancing Global Regulatory Harmonization for Cell and Gene Therapies: Enhancing Access and Innovation
Session Chair(s)
Akanksha Kaushal, MS
Director, Science and Regulatory Advocacy
PhRMA, United States
Regulatory and Industry experts will share opportunities to advance regulatory convergence and reliance for Cell and Gene Therapies, including the promotion of international regulatory harmonization by the ICH Discussion Group.
Learning Objective : Analyze global regulatory challenges and opportunities posed by current frameworks for CGT products; Discuss work under international organizations, such as ICH, to align regulatory expectations and harmonize technical requirements; Engage on opportunities to build on efforts by health authorities, such as, collaborative assessments, pilot programs to increase patient access to CGTs.
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