December 1, 2008

First FDA Regulatory Training & Certification Learning Portal Uses Powerful, Flexible Web Platform

Backend Admin Dashboard provides automatic information for creating benchmark industry reports

The first regulatory training and certification website for healthcare communicators uses CMEpilot’s web platform to create a highly functional and flexible custom learning portal (www.communicationcompliance.com).

The Center for Communication Compliance (CCC) created the concept and developed content for the new learning portal. It is designed to help pharmaceutical, medical device and biotech companies, and their public relations, advertising and medical education agencies successfully navigate the increasingly complex regulatory environment and to help industry set new standards in regulatory compliance literacy.

“Working with creator and president, Ilyssa Levins, we also engineered an extensive backend reporting function customized to CCC’s specific needs,” says Matthew Kicinski, president of CMEpilot (www.cmepilot.com). “It will provide CCC the statistical information to write insightful reports on the state of regulatory compliance expertise among healthcare communicators.”

Administration Dashboard

In addition to tracking enrollment, building and maintaining its database and capturing statistics about interest, participation and completed certificates, CMEpilot’s backend Administration Dashboard allows CCC to aggregate data to develop benchmark reports for industry.

Companies also can request confidential reports for each registered employee to enhance professional development initiatives, including quarterly or annual staff reviews. Every certification question can be tracked to compare the individual’s score with the department’s scores, including who passed, who failed, the average score and ranges. Knowledge “gaps” are readily apparent and will be used to guide future programming.

"We want to help the industry reduce risk, increase credibility and save money, “Levins says. “This requires a website platform that can adapt easily to updates and additional programs as we continually make new tools, programs and services available.

“CMEpilot’s professionalism every step of the way simplified what could have been a daunting process. Plus, the system’s powerful platform and flexibility meant we could make important changes quickly, including our current addition of new training modules and certification tests for additional communication sectors.”

CCC Learning Portal Provides Testing & Training

CCC’s flagship products are the Regulatory Compliance Tests (RCT) that were developed with CCC’s Advisory Board of former FDA officials, regulatory lawyers, and regulatory affairs experts from industry and professional consulting firms. The tests certify knowledge of:

1. Government regulations and voluntary industry guidelines
2. Development and execution of materials
3. Application of regulatory guidelines to complex healthcare communication scenarios

The learning portal also provides a series of Web-based training courses, “Regulatory Compliance 101,” taught by nationally recognized regulatory experts. The easy-to-download modules are designed to prepare learners for taking the certification tests.

In addition, there is easy access to a free library of links to more than 50 resources about regulations, policies and guidelines, as well as best-in-class books, articles and industry presentations -- organized and annotated for easy reference.

The first Regulatory Compliance Test, certification credentials, and training courses are directed to healthcare public relations professionals through their companies. Advertising and medical education training and certification programs will be launched in October, 2008.

Also in development is a Content Management System (CMS) for CCC to use to keep its public-facing pages up to date themselves with the latest relevant industry news. For more information about CCC, see www.communicationcompliance.com.