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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
VP, Global Regulatory Policy, 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
Principal, Leavitt Partners, United States
WHO Update
Samvel Azatyan, MD
Deputy Secretary-General, Council For International Organizations of Medical Sciences (CIOMS), Switzerland
PMDA Update
Yasuhiro Kishioka, PhD
Review Director, Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Industry Update
Maria Antonieta Roman
Head Regulatory Policy LaCan, Novartis, Mexico
EMA Update
Anabela Marcal, PharmD
EMA Liaison Official to the US FDA, European Medicines Agency, Netherlands
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