Registration
CCC offers diverse services and products to support regulatory compliance competency.
To register or to inquire, please use this form.
1. Drug Development 101 Training Seminar
This on-line, on-demand seminar is appropriate for any junior to mid-level professional in the pharmaceutical, biotech, or device industries, or at communication/promotional agencies, who needs a basic level of understanding of the drug development process.
The training seminar provides an overview of a drug's lifecycle, from drug discovery through post-marketing studies. It addresses at a basic level the pre-clinical and clinical phases, provides easy-to-understand definitions of diverse study designs and endpoints, and describes the role of clinical investigators. Staffers will be able to read abstracts and understand clinical study endpoints with greater ease.
The Web-based Training Seminar is taught by internationally recognized regulatory experts. The course is comprised of a lecture session which correlates to the Regulatory Compliance Test (RCT) – Drug Development 101. Each participating staff member may access the session 24/7 off the CCC Web site. Access is for a period of 12 months.
The training seminar, which is offered along with the certification test (RCT) as a complete educational package, is priced per individual employee, with significant volume discounts based on the number of staff registered.
2. Regulatory Compliance Test (RCT) - Drug Development 101
The RCT evaluates and validates the mastery of the information contained in the training module, Drug Development 101. This RCT, which is provided along with the training module as a complete educational package, is priced per individual employee, with significant volume discounts based on the number of staff registered.
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 the firm before using the access code to take the test, you may substitute another employee; simply send us the substitute employee's information.
CCC will e-mail 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.
3. Drug Development 101 Test Sampler
CCC offers the opportunity to take a Drug Development 101 Test Sampler to experience the Regulatory Compliance Test. The Test Sampler is available at no cost.
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.
5. Customized Reports
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.
6. Diagnostics
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.
7. Licensing of Certification Test (Industry Only)
The Regulatory Compliance Tests and Drug Development 101 Web-based training course are available for licensing. Please contact Ilyssa Levins for more information.
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 inquire, please use this form.