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Introducing the Format for the Roundtable Discussions
Session Chair(s)
Maria Vassileva, PhD
Chief Science and Regulatory Officer
DIA, United States
Topic 1: Regulatory Challenges: Ideas of How to Best Harmonize Regulations Globally and adapt existing regulatory processes in the context of application to cell and gene therapies to make sure they work for a fast-evolving field while driving innovation and encouraging cooperation
Topic 2: Ensuring Timely Access to Approved Therapies in Developing Countries with Patient Needs and Public Health Unmet Medical Needs in mind
Topic 3: CMC Hurdles with Cell and Gene Therapy Manufacturing
Speaker(s)
Topic 1: Regulatory Challenges - Moderator
Radha Goolabsingh
DIA, United States
Global Regulatory Strategist
Topic 2: Ensuring Timely Access to Approved Therapies in Developing Countries - Moderator
Maria Paula Bautista Acelas, MS
DIA, United States
Scientific Project Manager
Topic 3: CMC Hurdles with Cell and Gene Therapy Manufacturing - Moderator
Tamei Elliott, MS
DIA, United States
Associate Director, Scientific Programs
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