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Walter E. Washington Convention Center

Jun 14, 2015 2:30 PM - Jun 18, 2015 6:45 PM

801 Mount Vernon Place, NW, , Washington, DC 20001-3614 , USA

DIA 2015 51st Annual Meeting: Develop. Innovate. Advance.

Full conference and one-day registrants will have access to presentation PDFs through Friday, December 18, 2015 <A href="http://www.diaglobal.org/Flagship-Meetings/DIA-Annual-Meeting/Meeting-Program/ePac-Presentations-Access.aspx">Review Presentations </A>

Pharmacovigilance Concerns with the Use of Experimental Medicines for Ebola and Enterovirus B-68

Session Chair(s)

Elizabeth E. Garrard, PharmD

Elizabeth E. Garrard, PharmD

Executive Vice President, Global Safety Operations

Clinipace Worldwide, United States

The race is on to find a cure for Ebola which has killed more than 8000 people in West Africa and remains the largest outbreak on record. Over the last several months, the United States has experienced a nationwide outbreak of enterovirus D68 (EV-D68) associated with severe respiratory illness. The CDC and/or state public health laboratories have confirmed over 1100 people in 47 states and the District of Columbia with respiratory illness caused by EV-D68. There are no proven treatments for people with the Ebola or enterovirus D68 virus or vaccines to prevent infection in the first place. However, progress is now being made on an unprecedented scale. Trials, which would normally take years and decades, are being fast-tracked on a timescale of weeks and months. This session will discuss how fast-tracking clinical investigations has obvious shortcomings, most notably required understanding of the safety profile of the agents used to treat these epidemics. Another issue is that of ethical considerations in providing treatment during epidemics with agents that have not undergone robust clinical trials.

Learning Objective : Discuss the impact of fast tracking the regulatory process including the possible downstream effects on patient safety; Describe the ethical impact of the use of experimental medications and vaccines that have not been formally approved or even tested in humans; Identify if we will gain insight on antimicrobial resistance during epidemics.

Speaker(s)

Syed Rizwanuddin  Ahmad, MD, MPH, FISPE

Antimicrobial Resistance: Issues and Concerns

Syed Rizwanuddin Ahmad, MD, MPH, FISPE

Drug Safety Consultant, United States

Ex-Consultant/Safety Reviewer, FDA, Assoc Prof (adjunct), Rutgers, Georgetown

Raj  Long, MEd, MSc

Accelerating the Evaluation of Potential Treatments for Ebola

Raj Long, MEd, MSc

Bill and Melinda Gates Foundation, United Kingdom

Deputy Director, Safety and Pharmacovigilance

Bharat  Khurana, DVM, PhD, MBA

Expedited Development of Ebola Vaccines: Ensuring Safety

Bharat Khurana, DVM, PhD, MBA

FDA, United States

Microbiologist, OVRR, DVRPA, CBER

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