CCC Certification for Promotional Medical Education
The Regulatory Compliance Tests (RCTs) evaluate and validate mastery of the information contained in the respective training modules.
CCC certifies regulatory competency for Promotional Medical Education at two levels: Basic and Advanced. Our Regulatory Compliance Test (RCT): Promotional Medical Education is structured in three sections:
Basic RCT-A: Regulatory Environment
Basic RCT-B: Promotional Medical Education Materials and Tactics
Advanced RCT: Promotional Medical Education Scenarios
All three sections are administered online and are available on demand, 24/7. Questions are either multiple choice or True/False.
Basic Regulatory Competency: Promotional Medical Education
Passing Basic RCT-A and RCT-B certifies Basic Regulatory Competency in the essentials of regulatory compliance for Promotional Medical Education.
Basic RCT-A tests knowledge of the regulations and policies established by government agencies and industry groups.
Basic RCT-B tests competency in the development and execution of Promotional Medical Education materials within regulatory guidelines.
Each section of the Basic test takes approximately 30 minutes to complete. There are 20 questions in each section. A passing grade is 80%.
Advanced Regulatory Competency: Promotional Medical Education
Advanced RCT certifies Advanced Regulatory Competency – mastery of the application of regulatory guidelines to complex Promotional Medical Education scenarios with multiple factors at play.
Advanced RCT covers such topics as presentations at medical society conferences, speaker training and fees, key opinion leaders, and use of consultants for program development.
The Advanced test takes approximately 30 minutes to complete. All questions are multiple choice. There are 16 questions. A passing grade is 80%.
Promotional Medical Education Test Sampler
CCC offers the opportunity to take a Promotional Medical Education Test Sampler to experience the Regulatory Compliance Test. The Test Sampler is available at no cost.
RCT Educational and Test Prep Services
Regulatory Compliance 101: Promotional Medical Education
CCC offers professionals who design, execute, review, or oversee Promotional Medical Education a 3-module Web-based training seminar, Regulatory Compliance 101: Promotional Medical Education, taught by nationally recognized regulatory experts. Each hour-long session, containing lecture material and a Q&A segment, correlates with a section of the Regulatory Compliance Test (RCT): Promotional Medical Education, as shown below. Up to 300 members of your staff may access the sessions 24/7 off the CCC Web site, making this standardized Web-based educational service extremely economical. Access is for a period of 12 months.
Regulatory Compliance 101: Promotional Medical Education Module I – Addresses Basic RCT-A
Regulatory Compliance 101: Promotional Medical Education Module II – Addresses Basic RCT-B and Advanced RCT
Regulatory Compliance 101: Promotional Medical Education Module III – Addresses the entire Regulatory Compliance Test (both levels) through case studies
Consultation and On-site Customized Instruction with Regulatory Experts
CCC offers access to leading regulatory experts for telephone consultation and on-site customized instruction. The agenda is yours to determine, including questions related to the certification test or training seminar, a specific regulatory situation, a recently announced policy decision, execution of specific tactics, etc.
REMS
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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Webcasts
CCC offers insights on specific topics affecting regulatory compliance and risk communication, such as social media, REMS, and writing creatively in a regulated environment.