RALEIGH, N.C., Dec. 9 /PRNewswire/ -- PRA International, a leading Clinical Research Organization, announces its Scientific Head of Infectious Diseases Carl Kraus, M.D., Vice President of Scientific Affairs will host an audio conference along with John Powers, M.D., Assistant Professor of Medicine at George Washington University, on the design and regulatory environment considerations in anti-infective drug development.
Understanding the current regulatory environment and how it will affect the study design in anti-infective drug development is critical to addressing the present concerns of disease due to drug-resistant pathogens, biothreat agents, and novel influenza strains. The need to develop drugs with acceptable risk-benefit profiles for emerging and re-emerging diseases is evident. During the presentation, Drs. Kraus and Powers will review some of the basic principles surrounding anti-infective drug development in the framework of regulatory submissions as well as provide an update on some of the most important changes in recent years related to specific anti-infective indications. A question and answer discussion on selected infectious disease indications will follow their talk.
Both Drs. Powers and Kraus were formerly with the US Food and Drug Administration. At the FDA, Dr. Powers was the lead medical officer for Antimicrobial Drug Development and Resistance Initiatives, and Dr. Kraus was a medical officer in the Division of Special Pathogens and Immunologic Drug Products. Over the years, Dr. Powers has been involved in more than 50 clinical trials as a clinical investigator, has won several teaching awards, and has published extensively in the infectious disease field. Dr. Kraus has participated in more than 20 developmental programs for antiviral, antibiotic and biothreat agents and currently heads the Infectious Diseases Research Center (IDRC) at PRA.
PRA's IDRC is a cross-functional department comprised of staff from Scientific Affairs, Project Management, Patient Recruitment, and Clinical Informatics. The IDRC serves as a central collection point for infectious disease knowledge and provides cross-functional oversight of ongoing studies. Operating globally in Africa, South America, Asia-Pacific, Europe and the United States, IDRC experts offer PRA's clients significant expertise in the design and management of both individual protocols and complete clinical development programs.
The audio conference is scheduled for 16 December 2009 from 11:30 a.m. - 1:00 p.m. (ET). For additional information and to register, please navigate to www.praintl.com and click on "Events" under the News and Events heading.
About PRA International
PRA International conducts clinical trials in more than 75 countries across 6 continents and provides services through all phases of clinical development. PRA performs studies in all therapeutic areas, with specialization in infectious diseases, oncology, neurosciences, respiratory/allergy and cardiovascular. PRA has supported over 2,100 clinical trials through its 36 global offices.
PRA's therapeutic expertise, global reach and project experience, combined with extensive local knowledge and our differentiating PERSONAL ELEMENT enable our project teams to deliver consistent and on time performance for our clients. This unique PRA philosophy - THE PERSONAL ELEMENT - recognizes that true client service comes only from trained, empowered and dedicated employees who are encouraged to use innovation and their personal commitment to accelerate the development lifecycle.
SOURCE PRA International
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