Back to Agenda
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
Tierney Strategies, United States
Former FDA Chief of Staff and CBER Deputy Center Director
WHO Update
Samvel Azatyan, MD, PHD
Council For International Organizations of Medical Sciences (CIOMS), Switzerland
Senior Adviser
PMDA Update
Yasuhiro Kishioka, PHD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Review Director, Office of Cellular and Tissue-based Products
Industry Update
Maria Antonieta Roman
Novartis, Mexico
Head Regulatory Policy LaCan
EMA Update
Anabela Marcal, PHARMD
European Medicines Agency, Netherlands
EMA Liaison Official to the US FDA
Have an account?