Hear from the US FDA, the Australian Therapeutic Goods Administration, the Japanese at PMDA 2 September, 2010

Bethesda, Md. – The Parenteral Drug Association (PDA) is proud to announce the confirmation of expert regulatory speakers at this year’s Global Conference on Pharmaceutical Microbiology.

Thomas J. Arista, Investigator, National Expert, Pharmaceutical/Biotechnology, ORA/ORO, Division of Field Investigations,FDA will discuss Practical Regulatory Guidance on Risk Assessment for Microbial Controlled Issues.

The agenda includes discussions on topics such as objectionable microorganisms, investigations of microbial data deviations, manufacturing and product attributes impacting sterility assurance, new technologies and more.

A highlighted session at this conference, scheduled for October 25-28, 2010 in Washington, D.C., is Global Regulatory Perspectives on RMM. It will provide an overview on current perspectives and future directions of various regulatory agencies across the globe (FDA/CDER, FDA/CBER, TGA and PDMA) in the area of Rapid Microbiology Methods (RMM) as it applies to product testing and release.

Confirmed speakers include: Vivienne Christ, PhD, Chief Microbiologist, OLSS, Therapeutic Goods Administration, David Hussong, PhD, Director, Microbiology, CDER, FDA, Rajesh Gupta, PhD, Deputy Director, Division of Product Quality, Office of Vaccines Research and Review, CBER, FDA and Tsuguo Sasaki, PhD, GMP Expert, Office of Compliance and Standards,PMDA.

For more information, visit www.pda.org/microbiology2010. Press inquiries about registration should be directed to PDA’s Adrienne Fierro, fierro@pda.org.