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Wednesday, June 29 • 4:00pm - 5:15pm
#366: Infectious Disease Containment and Lessons Learned

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Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-565-L01-P; CME 1.25; IACET 1.25; RN 1.25

This session will bring together industry, health scientists, and regulators to discuss scientific, regulatory, and other issues related to advancing preparedness for Ebola vaccine development based on the previous year’s experience.

Learning Objectives

Identify important scientific lessons learned from the Ebola outbreak of 2014 and the vaccine development process; Identify scientific and regulatory issues to address future Ebola vaccine development.

Chair

Jinjie Hu, PhD

Speaker

How Can We Develop Medicinal Products for Emerging Disease?
Junko Sato

Regulatory Response and Pathways for Licensure of Ebola Virus Vaccines: FDA Perspective
Sara Gagneten, PhD

Ethical Perspective
Walter Straus



Chair
JH

Jinjie Hu

co-chair of FDAAA International Network committee; Senior Consultant, Biologics Consulting Group
Dr. Hu received her Ph.D. in Comparative Pathology from UC, Davis, followed by postdoctoral fellowship at the NIAID, NIH. She worked at FDA for almost 12 years where she is recognized as the IVD expert on FDA regulation and QSR requirement. She chaired many review committees for 510... Read More →

Speakers
avatar for Sara Gagneten

Sara Gagneten

Associate Div Director, Policy, Office of Vaccines Research and Review, CBER, FDA
Dr. Gagneten completed her graduate studies at the Uniformed Services University for the Health Sciences (USUHS) in Maryland and conducted research in virology and genetic recombination before joining the Office of Vaccines Research and Review (OVRR) at CBER, FDA. Currently she is... Read More →
avatar for Junko Sato

Junko Sato

Office Director, Office of International Cooperation, Pharmaceuticals and Medical Devices Agency (PMDA)
She joined the agency in 1998. She has work experiences in new drug review for 11 yrs, risk management for 3 yrs and international area for 6yrs. She also worked in U.S.FDA as a guest reviewer 2002-2003, and in EMA as the Japan Liaison Officer, 2012-2014. She is actively involved... Read More →
avatar for Walter Straus

Walter Straus

Associate Vice President, Therapeutic Area Head, Clinical Safety and Risk Mgmt, Merck & Co., Inc.
Dr. Straus’ team oversees global clinical safety for investigational products as well as post-licensure safety monitoring and assessment for the Merck portfolio in vaccines and infectious disease therapeutics. He is trained as an internist, gastroenterologist, and epidemiologist... Read More →


Wednesday June 29, 2016 4:00pm - 5:15pm
202AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA