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Walter E. Washington Convention Center

2025 年 06 月 15 日 7:15 上午 - 2025 年 06 月 15 日 5:45 下午

801 Allen Y. Lew Place, NW, Washington, DC 20001-3614, USA

Global Regulatory Harmonization and Improving Access to Advanced Therapies Summit

Registration Ends In

DAYS

HOURS

MINUTES

SECONDS

Introducing the Format for the Roundtable Discussions

Session Chair(s)

Maria  Vassileva, PhD

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)

Radha  Goolabsingh

Topic 1: Regulatory Challenges - Moderator

Radha Goolabsingh

DIA, United States

Global Regulatory Strategist

Maria Paula  Bautista Acelas, MS

Topic 2: Ensuring Timely Access to Approved Therapies in Developing Countries - Moderator

Maria Paula Bautista Acelas, MS

DIA, United States

Scientific Project Manager

Tamei  Elliott, MS

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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