PRZOOM - /newswire/ -
Eatontown, NJ, United States, 2009/02/11 - New agreement creates the foundation for expanded cooperation among US and non-US government regulatory agencies to achieve consistent regulatory enforcement.
Kaplan EduNeering, a leading provider of compliance and knowledge management solutions and the US Food and Drug Administration (FDA) have expanded their Cooperative Research and Development Agreement (CRADA) to support the educational needs of government regulatory agencies outside the US using unique technology and content specific to FDA regulations. Other U.S. government agencies will also benefit by the ability to share consistent education relevant to the needs of their constituents.
“Through this expansion of our initial agreement, we are harnessing the power of advanced technology and specific learning content in response to global challenges,” said Lisa Clune, Kaplan EduNeering’s President. “Kaplan EduNeering has been a partner to FDA for many years in online training for its federal, state and local investigators. The new CRADA expands that partnership and helps assure that high standards of safety for FDA-regulated products are met in the US and beyond our borders, as well as improving consistent education across other key US government regulatory agencies.”
The expanded agreement enables the following:
• Use of the ComplianceWire® technology to extend access to regulators outside the US. ComplianceWire is Kaplan EduNeering’s web-based 21 CFR Part 11 technology that enables the distribution, validation of receipt, testing and documentation of all learning activities.
• Translation of courses into multiple languages for use by regulators and industry in China, Mexico and Canada, as well as other nations based on mutual agreement.
• Access to the CRADA curricula by other US government regulatory agencies.
The original CRADA between FDA and Kaplan EduNeering (kaplaneduneering.com) was launched in 1999 as the first learning technology agreement of its kind between FDA and a private-sector company. The cornerstone of the partnership is the Office of Regulatory Affairs’ virtual university, known as ORA U, which Kaplan EduNeering and FDA have co-developed. ORA U’s more than 100 web-based learning activities and courses are accessible to over 30,000 federal, state and local investigators. This same solution—technology and content—is available to regulated industry. In addition to FDA, ComplianceWire is used by the National Institutes of Health, the US Department of Agriculture, and approximately 100 life sciences companies with employees in more than 50 countries.