Registration
CCC offers multiple services and products to support regulatory compliance competency.
To register or to inquire, please use this form.
1. Regulatory Compliance Test (RCT): Advertising/Promotion
The cost to certify an individual employee at the basic level starts at $400, with significant volume discounts based on the number of staff registered for RCT certification. Staff initially registered for the Basic RCT can sign up at a later time for the Advanced RCT.
Registered employees have a year to take the test, and are allowed three attempts to pass. At the end of one year, all unused access codes are disabled; no refunds or credits will be issued for any access codes unused within that period.
If a registered employee leaves your firm before they have used the access code to take the test, you may substitute another employee; simply send us the substitute employee’s information.
CCC will email you a confidential access code for each employee on your list of registrants so they can proceed to the Log In button on the CCC Web site to begin.
2. Regulatory Compliance 101: Advertising/Promotion 3-Module Web-based Training Seminar
CCC offers a 3-module Web-based Training Seminar, Regulatory Compliance 101: Advertising/Promotion, taught by nationally recognized regulatory experts. The course includes 3 one-hour sessions. Each session, containing lecture material and a Q&A segment, correlates with a section of the Regulatory Compliance Test (RCT): Advertising/Promotion, as shown below. Up to 100 members of your staff may access the sessions 24/7 off the CCC Web site, making this standardized Web-based educational service extremely economical. The course price is $6500. Access is for a period of 12 months.
Regulatory Compliance 101: Advertising/Promotion Module I – Addresses Basic RCT-A
Regulatory Compliance 101: Advertising/Promotion Module II – Addresses Basic RCT-B and Advanced RCT
Regulatory Compliance 101: Advertising/Promotion Module III – Addresses entire Regulatory Compliance Test (both levels) through case studies
3. Advertising/Promotion Test Sampler
CCC offers the opportunity to take an Advertising/Promotion Test Sampler to experience the Regulatory Compliance Test. The Test Sampler is available at no cost; you may register for it by using the form at the bottom of this page.
General
4. Consultation and On-site Customized Instruction with Regulatory Experts
CCC provides access to leading regulatory experts for telephone consultation and on-site customized instruction. The customized agenda can include questions related to the certification test or training seminar, a specific regulatory situation, a recently announced policy decision, execution of specific tactics, etc. Consulting time requested and level of customization determines the cost.
Throughout a brand's life cycle, there is a required continuum of strategy and execution needs to satisfy the requirements of Risk Evaluation and Mitigation Strategy (REMS), a provision added to the FDA Amendment Act (FDAAA) in 2007. CCC helps to ensure that risk information is communicated effectively and proactively – both internally and externally. This includes counsel and execution in regard to REMS creation, research, education, preparedness planning, and organizational development.
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CCC offers insights on specific topics affecting regulatory compliance and risk communication, such as social media, REMS, and writing creatively in a regulated environment.
Customized reports on test results are available to support staff development (e.g., for annual reviews). Data can be broken down by employee level, years in the business, and specific regulatory subjects. Level of detail determines the cost.
CCC audits the internal processes of companies and agencies and develops customized recommendations for creating a culture of compliance throughout the organization. This includes recommendations to strengthen the review procedure prior to submission of materials; compliant use of e-mail; and a version control process for program recommendations. Cost varies based on level and scope of audit. Similar versions are also available for industry.
9. Customization and Licensing of Certification Test and 3-Module Course (Industry Only)
CCC custom-designs a learning management system (LMS) to train and certify employees that includes interactivity, drag-and-drop testing, embedded quizzes, and mastery testing. Throughout the coursework are examples of violative claims, fair balance prominence, directional statements, etc. Additionally, the Regulatory Compliance Tests and Regulatory Compliance 101 Web-based training courses are available for licensing. Please contact Ilyssa Levins for more information.
10. Certification Library
CCC currently has a library of over 250 validated questions and answers that reflect what federal and state laws, regulations, policies, and voluntary industry codes require, based on a consensus perspective of experienced experts, including former FDA officials and legal and regulatory experts. Based on a drug or device company’s existing regulatory compliance training curriculum, CCC will mine questions from its library to correlate with the company’s existing training content.
Once CCC’s test construction team has correlated questions to content, the optimal test length will be established, including the appropriate sequence of questions and scoring system. This includes the question configuration (e.g., true/false or multiple choice) and number of possible answers per question.
These services meet a growing need among drug and device companies whose existing regulatory training programs currently do not confirm employee mastery of the content provided by the curriculum.
NOTE: Passing a certification test, training, and other CCC services are among the many steps that healthcare communication professionals need to take to address the challenging regulatory environment.
To register or to enquire, please use this form.