U.S.Global
Drug Development 101Country Specific Modules

Registration

CCC offers multiple services and products to support regulatory compliance competency.

To register or to inquire, please use this form.

Global Programs: Approval & Promotion for:

Advertising/Promotion

Public Relations

1. Regulatory Compliance 101: Global Compliance Training Seminars 

CCC offers standardized regulatory compliance training for Advertising/Promotion in the following areas:

Module 1: Application/Dossier Submission and Approval
Addresses what you need to know about application/dossier submission for and approval of new drugs/devices in the country(ies) of interest. While this module is largely applicable to Regulatory Affairs, any professional in the pharmaceutical, biotech, or device industry, or their agency vendors, will benefit from mastery of the information.

Module 1 Expanded: Approval of Promotional Materials By Regulatory Authorities
Addresses what you need to know about the approval of promotional materials for new drugs/devices in the country(ies) of interest. While this module is largely applicable to regulatory affairs professionals, any professional in the pharmaceutical, biotech, or device industry, or their agency vendors, will benefit from the information.

CCC offers standardized regulatory compliance training for two distinct disciplines, Public Relations (PR) and Advertising/Promotion, in the following area: 

Module 2: Global Promotional Compliance
Addresses what healthcare professionals (inside companies, at agencies, consultants) need to know about promotional regulatory compliance in the country(ies) of interest. This module is for any professional in the pharmaceutical, biotech, or device industry, or their agency vendors, who works with, designs, executes, reviews, or oversees global promotional programs, including but not limited to: Communications, Marketing and Sales, and Compliance and Ethics. This lecture session on global promotional regulatory compliance correlates with the Regulatory Compliance Test (RCT) for the country(ies) addressed.

For both Modules 1 and 2, coursework is available at a per person price. Course materials are accessible 24/7 from the CCC Web site. Access is for a period of 12 months.

Click Here to Register or Inquire

Click Here to See Curriculum for Advertising/Promotion

Click Here to See Curriculum for Public Relations

2. Global Regulatory Compliance Test (RCT) for:

Advertising/Promotion 

Public Relations 

CCC certifies regulatory compliance competency for the execution of promotional materials and programs around the world. The Regulatory Compliance Test (RCT) is applicable to any professional in the pharmaceutical, biotech, or device industry, or their agency vendors, who works with, designs, executes, reviews, or oversees global promotional programs, including but not limited to: Communications, Marketing and Sales, and Compliance and Ethics.

The RCT is administered online and available on demand, 24/7. Questions are either multiple choice or True/False. The RCTs evaluate and validate mastery of the information contained in the respective training modules. RCTs are provided along with the training modules as a complete educational package for the country(ies) of interest. For additional information regarding the focus of these global training modules:

Click Here for the Global Course Curriculum for Advertising/Promotion

Click Here for the Global Course Curriculum for Public Relations

Sign up for Certification

3. Global Promotion Test Sampler for:

Advertising/Promotion 

Public Relations

CCC offers the opportunity to take the Global Promotion Test Samplers to experience the RCT. The Test Sampler are available at no cost.

Click Here to Request the Test Samplers

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 Regulatory Compliance 101: Global Compliance Web-based training courses 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.