New Policy Summit Speakers: Global Regulators Will Talk Convergence Efforts for CGTs
Join us Sept. 23-24 at the Westin Washington DC Downtown Hotel or virtually! - July 22, 2024
Presenters from regulatory agencies in Spain, Japan, and the United States will discuss considerations for earlier approval pathways and how their agencies are thinking about CGT regulation into the future.
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The global convergence of regulatory standards can significantly impact the efficiency and success of bringing new cell and gene therapies to market. On Sept. 23, the first day of the Policy Summit, the global regulatory convergence session will explore the intricacies of international collaborations and pilots while highlighting the benefits and challenges of both formal and informal harmonization efforts. Don't miss your chance to engage with these decision-makers!
Dr. Sol Ruiz is the Head of the Division of Biological Products, Advanced Therapies, and Biotechnology at the Spanish Agency of Medicines and Medical Devices (AEMPS). She previously chaired the Biologics Working Party of the European Medicines Agency (EMA). Dr. Ruiz also represents Spain on EMA's Committee for Advanced Therapies.
Dr. Yasuhiro Kishioka is the Review Director in the Office of Cellular and Tissue-based Products at the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. Dr. Kishioka has engaged in various international regulatory activities, contributing to organizations such as WHO, APEC, IPRP, and ICH, where he was appointed as the ICH Q12 topic leader. Additionally, he has worked in the Office of International Programs and served as the ICH Technical Coordinator.
Dr. Nicole Verdun is Director of FDA CBER's Office of Therapeutic Products. She has over a decade of service with the Agency, including in the Office of Hematology and Oncology Products and the Office of Therapeutic Biologics and Biosimilars at the Center for Drug Evaluation and Research (CDER). Dr. Verdun joined the Center for Biologics Evaluation and Research (CBER) in 2016 in the Office of Blood Research and Review.
The 2024 Policy Summit will be offered in a hybrid format, with in-person and virtual registration options. Both options include access to on-demand content for 30 days following the event. In-person registration will be limited – so register early to secure your spot in Washington, DC!
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