The current regulatory environment in anti-infective drug development is changing due to updates in submission requirements as well as the potential for risk mitigation strategies post-launch. Conversely, the need to develop drugs with acceptable risk/benefit profiles for emerging and re-emerging infectious diseases is certainly present considering the rising concerns of disease due to drug-resistant pathogens, biothreat agents and novel influenza strains.
In this conference our speakers review some of the basic principles surrounding anti-infective drug development in the framework of regulatory submissions. They also provide an update on some of the most important changes in recent years related to specific anti-infective indications.
Design and Regulatory Considerations in Anti-Infective Drug Development is being presented by Dr. John Powers, George Washington University School of Medicine & Dr. Carl Kraus, PRA International and airs on Wednesday, December 16, 2009. For more details or to register, please visit our site at www.fxconferences.com
