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Bringing Transformational Treatments to Patients: Regulatory Convergence and Reliance on Cell and Gene Therapy Products
Session Chair(s)
Ginny Beakes-Read, BSN, JD
Head, Global Regulatory Policy and Intelligence
Johnson & Johnson Innovative Medicine, United States
In this session, we will discuss international efforts to promote regulatory convergence and expand the use of reliance to bring these highly complex therapies to market earlier, particularly in less developed countries.
Learning Objective : Describe how international harmonization, collaboration, and reliance principles can be effectively applied to the regulation of cell and gene therapies; Discuss the key considerations and regulatory challenges associated with bringing complex, innovative medicines such as cell and gene therapy products to less experienced, emerging markets.
Speaker(s)
FDA Update
Julia Tierney, JD
FDA, United States
Deputy Center Director for Strategy, Policy, and Legislation, CBER
WHO Update
Samvel Azatyan, MD, PhD
World Health Organization (WHO), Switzerland
Team Lead, Regulatory Convergence and Networks (RCN/REG)
PMDA Update
Yasuhiro Kishioka, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Reviewer Director, Office of Cellular and Tissue-based Products
Industry Update
Maria Antonieta Tony Roman, MPharm
Novartis, Mexico
Head Regulatory Policy Emerging Markets LATAM
EMA Update
Anabela Marcal, PharmD
European Medicines Agency, Netherlands
EMA Liaison Official to the US FDA
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