As a regulatory professional, confidence comes from having the answers you need. But what do you do when the answers just aren't there? 2014 RAPS will give you the know-how to tackle your toughest issues.
Local or global—RAPS has you covered with offices in Washington, DC, Shanghai and Singapore. There are RAPS chapters in Canada, Israel, Switzerland, Taiwan and throughout the United States, and local networks in Australia, Belgium, Brazil, Germany, India, Mexico, The Netherlands, Poland and Singapore.
In an environment where medical product regulations seem to be expanding continuously, proportional investment in compliance infrastructure and controls runs the risk of diminishing returns. The key to achieving the right balance of commercial success and compliance is to focus on continuous improvement, specifically root-cause analysis.
The US Food and Drug Administration (FDA) has published a new draft guidance intended to assist industry with developing products under the agency's so-called "Animal Rule," a regulatory pathway intended to facilitate approvals of medical countermeasures to rare, emerging or serious pathogens.
LifeCenter Organ Donor Network encourages and coordinates the donation of human organs and tissues for transplantation. We are an independent, not-for-profit, organ procurement organization serving Southwestern Ohio, Northern Kentucky and Southeastern Indiana. LifeCenter Organ Donor Network is a member of the United Network for Organ Sharing (UNOS) and follows all federal guidelines for organ shar...ing as outlined by the Organ Procurement and Transplant Network (OPTN) and tissue banking by the American Association of Tissue Banks (AATB).