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  1. News & Events for Human Drugs

Seventh Annual Predictive Safety Testing Consortium (PSTC) / FDA CDER Scientific Workshop

Goals and Objectives

The purpose of this scientific workshop is to discuss the impact of safety biomarkers on drug development. The workshop will also serve to discuss the use of other nonclinical species beyond rodents in biomarker qualification, as well as assay validation expectations throughout the qualification process, and toxicometrics as a translational safety strategy that integrates nonclinical and clinical safety approaches with non-safety disciplines.

Who Should Attend:

This workshop is intended for a diverse group of scientists from FDA, Critical Path Institute (C-Path), and other interested parties regarding ongoing efforts on research and development of safety biomarkers and drug development tools.

The primary audience includes academic experts, interested pharmaceutical companies, regulatory agencies, patient advocacy groups, non-profit organizations, scientists and clinicians from regulatory, academic, industrial and other healthcare sectors involved in drug development in the US and abroad. Those individuals from the fields such as medicine, toxicology, statistics, clinical pharmacology who are involved in qualification of safety biomarkers or directly impacted by the qualification of safety biomarkers for drug development are encouraged to attend.

Register Now:

Persons interested in attending this meeting in person must register online by April 11, 2016 at http://www.cvent.com/d/2fqzl2/4Wdisclaimer icon. Early registration is recommended because limited seating is available. Registration is free and will be on a first-come, first-served basis. Onsite registration on the day of the scientific workshop will be based on space availability.

For questions regarding registration, and those interested persons without Internet access, please contact Stephanie Codd Anderson, 520-647-8376, Email: scanderson@gmail.com, at the Critical Path Institutedisclaimer icon, 520-547-3440.

If you need special accommodations because of disability, please contact Stephanie Codd Anderson, at least 7 days before the scientific workshop.

Contact

Stephanie Codd Anderson, Critical Path Institute, Predictive Safety Testing Consortium, 1730 E. River Rd., Tucson, AZ 85719, Email: scanderson@gmail.com, Telephone: 520-647-8376, Fax: 520-547-3456