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Trk 10: Pub Pol/HealthCare Compl/Law [clear filter]
Wednesday, June 29
 

10:30am EDT

#318: Changes to Common Rule Likely Affecting FDA-Governed Research
Limited Capacity seats available
Component Type: Session
Level: Advanced
CE: CME 1.00; IACET 1.00; RN 1.00

Although the Common Rule for research does not govern FDA governed clinical investigations, the proposed changes likely will eek over into FDA governed research. This session explores those proposed changes and their expected effects.

Learning Objectives

List key proposed changes to the Common Rule for Research; Contrast changes to FDA's requirements; Hypothesize how changes will affect FDA governed research.

Chair

David Vulcano

Speaker

Industry Perspective
David Vulcano

Industry Perspective
Neil McCullough


Chair
avatar for David Vulcano

David Vulcano

Vice President, Clinical Research Compliance and Integrity, HCA Healthcare, United States
David is a well-known leader in the clinical research industry through numerous associations, boards and initiatives. Among other things he is currently employed by HCA Healthcare, the largest private healthcare provider in the United States, as the Responsible Executive for Clinical... Read More →

Speakers
NM

Neil McCullough

Executive Vice President, Clinical Quality Compliance, ICON Clinical Research
Dr. McCullough has vast experience leading global quality and compliance teams within the industry. His expertise in quality assurance, regulatory affairs, risk-based auditing, continuous improvement, and project management are relied upon by PPD and its clients to achieve high quality... Read More →

Wednesday June 29, 2016 10:30am - 11:30am EDT
202AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 10: Pub Pol/HealthCare Compl/Law, Session |   Trk 01: Clinical Operations, Session

4:00pm EDT

#366: Infectious Disease Containment and Lessons Learned
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

Director, Office of International Programs, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Sato joined the Pharmaceuticals and Medical Devices Agency (PMDA) in 1998, and she is currently the Office Director for the Office of International Programs. She has work experiences in new drug review for 11 yrs, risk management for 3 yrs, and international area for 6 yrs. She... Read More →
avatar for Walter Straus

Walter Straus

Vice President, Safety and PV, Moderna, United States
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 EDT
202AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 10: Pub Pol/HealthCare Compl/Law, Session