Trk 10: Pub Pol/HealthCare Compl/Law [
clear filter]
10:30am EDT
#318: Changes to Common Rule Likely Affecting FDA-Governed Research
Chair
Vice President, Clinical Research Compliance & Integrity, Hospital Corporation of America (HCA)
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, the largest private healthcare provider in the United States, as the Responsible Executive for Clinical Research...
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Speakers NM
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...
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Wednesday June 29, 2016 10:30am - 11:30am EDT
202AB
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
4:00pm EDT
#366: Infectious Disease Containment and Lessons Learned
Chair JH
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...
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Speakers
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...
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Director, Office of International Programs, Pharmaceuticals and Medical Devices Agency (PMDA)
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...
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Associate Vice President, Therapeutic Area Head, Vaccines & Infectious Disease, Merck Research Laboratories
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...
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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
- Credit Type ACPE, CME, IACET, RN
- Audience Intermediate
- Featured Topics Current Issues in Policy and Law, Vaccines
- Interest Area Public Policy - Health Care Compliance - Law, Regulatory Affairs, Clinical Research
- format json
- Interest Area Public Policy / Health Care Compliance / Law,Regulatory Affairs,Clinical Research
- Featured Topics Current Issues in Policy and Law,Vaccines
- Credit Type ACPE, CME, IACET, RN
- Tags Session